Early Communication Intervention for Deaf/Hard of Hearing Toddlers: A Randomized Clinical Trial.

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Published in final edited form as: Pediatrics. 2025 Jun 1;155(6):e2024066847. doi: 10.1542/peds.2024-066847 Early Communication Intervention for Deaf/Hard of Hearing Toddlers: A Randomized Clinical Trial Maranda K Jones a , Katherine Zanzinger a , Jeffrey Grauzer a , Laura Sudec a , Aaron J Kaat b , Megan Y Roberts a Author information Copyright and License information a Roxelyn and Richard Pepper Department of Communication Sciences, School of Communication, Northwestern University, Evanston, IL b Department of Medical Social Sciences, Feinberg School of Medicine, Northwestern University, Chicago, IL Contributors Statement Page Dr. Maranda Jones contributed to the conceptualization and design of the study, collected data, carried out the analyses, and drafted the initial manuscript. Katie Zanzinger designed the data collection instruments, collected data, and reviewed the manuscript. Laura Sudec coordinated and supervised data collection, collected data, and reviewed the manuscript. Jeffrey Grauzer designed the data collection instruments, supervised data collection, and contributed to the data analysis. Dr. Aaron Kaat contributed to the conceptualization and design of the study, supervised the data analysis, and reviewed the manuscript. Dr. Megan Roberts conceptualized and designed the study, supervised data collection and analyses, and reviewed the manuscript. All authors approved the final manuscript as submitted and agree to be accountable for all aspects of the work. ✉ Address correspondence to : Megan Y. Roberts, PhD, CCC-SLP, 2240 Campus Drive, Evanston, IL 60208, megan.y.roberts@northwestern.edu . PMC Copyright notice PMCID: PMC12278989  NIHMSID: NIHMS2093041  PMID: 40419285 The publisher's version of this article is available at Pediatrics Abstract Objective: To maximize outcomes for deaf/hard of hearing (DHH) children, it is essential to develop effective early interventions. Parent-mediated interventions (PMIs) are a promising form of early communication interventions for DHH toddlers. The current study tests the effect of the PMI by evaluating (1) the effect of the PMI on parent strategy use and child communication and (2) the extent to which communication mode moderates these effects. Methods: This single-site parallel stratified clinical trial (2×2; hearing device, communication mode) enrolled 96 parent-child dyads. Child inclusion criteria were: (a) between 12–18 months, (b) diagnosed with bilateral hearing loss, (c) no additional diagnoses, (d) had at least one parent with typical hearing, and (e) exposed to some degree of spoken language by their parents. Communication mode (i.e., how a language is conveyed) was measured as exposure or no exposure to sign. Dyads were randomized to the PMI or control group. The PMI occurred weekly via telehealth over 6 months. Outcomes were measured before, during, and immediately after intervention. Results: Parent strategy use (d = 1.57) and child communication (d = 0.59) were greater for participants in the PMI group, indicating a statistically and clinically significant intervention effect. The intervention effect on child communication was significantly greater for children exposed to signs than children not exposed to signs (B = 18.93, SE = 8.09, P = 0.02). Conclusion: The PMI effectively facilitates parent strategy use and child communication outcomes. Moreover, this early communication intervention seems particularly beneficial for parent-child dyads who use sign. Article Summary Results of the first large-scale randomized clinical trial support the efficacy of a parent-mediated communication intervention for deaf/hard of hearing toddlers. The onset of universal newborn hearing screenings and advancements in early hearing technology, including cochlear implants, have contributed to the vast improvement in long-term outcomes for deaf/hard of hearing (DHH) children. 1 , 2 Nonetheless, significant variability remains in language outcomes for DHH children, many of whom do not “catch up” to their hearing peers. 3 – 9 Persistent language learning difficulties may, in part, be attributed to early language learning experiences. During the critical period of language development between birth to three years old, 10 DHH children experience reduced access to fluent, natural language input inciting a negative developmental cascade that contributes to discrepancies in long-term language outcomes. 11 – 16 To support long-term outcomes for DHH children, Early Hearing Detection and Intervention (EHDI) guidelines recommend that all newborns should (a) complete a hearing screening by 1 month of age, (b) receive a definitive diagnosis of hearing loss by 3 months of age, and (c) enroll in early intervention by 6 months of age. 17 Early communication interventions demonstrate the potential to enhance language learning experiences and disrupt the negative consequences of early language deprivation; however, there is a paucity of intervention research for DHH children. 18 Preliminary evidence suggests that parent-mediated interventions (PMIs), whereby parents are taught to use communication support strategies with their child, are a promising approach to early intervention for DHH children. 19 – 27 The current study is the first large-scale randomized clinical trial designed to evaluate the efficacy of a PMI targeting communication outcomes for DHH toddlers. PMIs may enhance DHH toddler’s communication outcomes for several reasons. First, it is well known that the quantity and quality of parent language input is associated with improved long-term child language outcomes across a variety of clinical populations, including DHH children. 26 , 28 – 32 The current PMI is adapted to the language learning needs of DHH children, such that the strategies elicit parent behaviors associated with improved communication outcomes for DHH children. 19 – 24 , 26 , 27 Second, earlier intervention is associated with improved language outcomes for children with communication disorders, including DHH children. 18 , 33 – 35 Results of numerous high-quality, large-scale clinical trials indicate that PMIs are an efficacious approach for children with communication disorders. 36 While these findings suggest that early intervention and high-quality parent language input are associated with positive language outcomes for DHH children, these studies have largely been descriptive. The current study leverages the methodological rigorous experimental design of a randomized clinical trial to isolate the precise effects of an early intervention designed for DHH children. Within early interventions for DHH children, one particularly salient consideration relates to the optimal communication mode (i.e., the means through which a language is conveyed, such as speech or sign) for language learning. 37 , 38 Given that spoken language is a primary goal for many families, decisions related to communication mode tend to be based on how supplemental modalities, in addition to speech, may support spoken language acquisition. 39 – 41 For example, visual input (i.e., signs) may be incorporated to supplement the auditory input (i.e., speech) used to convey a spoken language (e.g., English). a While some argue that signing hinders spoken language development, 42 others argue that signing facilitates spoken language development. 43 , 44 Here, we consider communication mode as a moderator of intervention effects to understand the extent to which signing affects outcomes of an early communication intervention. Understanding if and under what conditions the current early intervention facilitates outcomes is essential to bringing the intervention to scale for implementation in clinical practice settings. The randomized control trial of the PMI is guided by the following research questions: To what extent do (a) parent strategy use and (b) child communication outcomes differ between the PMI and control groups during and after intervention? To what extent does communication mode moderate the effect of the PMI on parent and child outcomes? Results of the current study are an important first step in understanding effective intervention approaches for DHH toddlers. We note the important distinction between (a) using sign as a communication mode to support spoken language acquisition and (b) the acquisition of a natural sign language, such as American Sign Language. For a full review, see Mayer & Trezek (2023). Methods Trial Design This single-site parallel stratified randomized clinical trial enrolled 96 parents and their DHH toddlers ( NCT03803943 , clinicaltrials.gov ). Using a 1:1 allocation ratio, dyads were randomized to receive the PMI or the control group (See Figure 1 CONSORT Chart). The business-as-usual (BAU) control group and the PMI group continued to receive any early intervention services separate from the current study (i.e., community-based services). The PMI group also received the intervention through the current clinical trial. The randomization sequence was computer generated and accessed only by the data analyst. The project coordinator completed group allocation after eligibility criteria were verified and all baseline assessments were completed. Randomization was stratified on hearing device and communication mode. Hearing device was dichotomized as either (a) hearing aid (n = 42) or (b) cochlear implant, cochlear implant candidate, or bone conduction device (n = 52). At baseline, 44 of the 46 children with cochlear implants had activated cochlear implants. The remaining two participants had their cochlear implants activated within the first month of the study. Between baseline and post-intervention, 3 participants without cochlear implants received bilateral cochlear implants, including one participant that was not originally identified as a cochlear implant candidate. Communication mode was dichotomized as using visual communication with the child (a) less than 10% of the time (i.e., no sign subgroup; n = 63) or (b) 10% or more of the time (i.e., sign subgroup; n = 31), per parent report. 42 Table S1 includes of description of the child’s language access profile as measured by the DHH Language Exposure Assessment Tool (D-LEAT). 45 FIGURE 1. Open in a new tab Consolidated Standards of Reporting Trials chart. Data collection and management were completed using REDCap databases. The institutional review board (IRB) at Northwestern University approved all study procedures. All parents completed a written, informed consent. Research staff documented all protocol deviations and adverse events, which did not differ between groups (see Table S2 ). Sample Size A pilot study of the PMI, which included 19 parent-child dyads, yielded an effect size of d = 1.09 for the intervention effect on child communication. 25 Given an estimated sample size of n = 86 (96 recruited with 10% attrition), pre-trial power analyses projected greater than 99% power to detect an effect of d = 1.09. The actual sample size included 96 parent-child dyads, 94 of whom were randomized, and 90 of whom completed post-intervention assessments. With the achieved sample size of n = 90 (96 recruited with 6.25% attrition) and 80% power, we were able to detect a main effect of greater than d = 0.60. Participants Participants were recruited nationwide from March 2020 until September 2022 via hospitals, early intervention providers, and social media advertisements. Families from across 33 states were enrolled in the study. Child inclusion criteria were as follows: (a) between 12–18 months old at enrollment, (b) diagnosed with bilateral hearing loss, (c) no additional diagnoses that impact communication, (d) at least one parent with typical hearing, and (e) exposed to some degree of spoken language by their parents. Two participating parents, both of whom were the child’s mother, were diagnosed with hearing loss. Eight of the non-participating fathers were reported as having been diagnosed with hearing loss. Two of the participating families self-identified as being a part of Deaf culture and American Sign Language users, including one family with a Deaf mother/hearing father and one family with a Deaf father/hearing mother. See Tables 1 and 2 for baseline assessment and demographic information as well as Table S3 and S4 for a breakdown by communication mode. The only baseline variables that differed between the groups was biological sex. To reduce potential bias, biological sex was controlled for in all statistical models. Table 1. Child Baseline Assessment and Demographic Variables. Control (n = 48) PMI (n = 46) Child Variables M (SD) M (SD) ECI Total Weighted Score 49.0 (32.6) 54.7 (30.0) CSBS Raw Score 58.7 (23.6) 67.5 (24.7) LittlEARS 57 Total Scores 22.5 (8.0) 25.6 (7.3) Age at Diagnosis 2.0 (2.6) 1.9 (3.1) Age at Current Device Fitting/Activation 8.5 (4.8) 6.9 (4.2) Age at Study Enrollment 15.5 (2.1) 15.6 (1.8) Community-Based Services in Hours per Week 1.2 (1.7) 0.9 (0.8) n (%) n (%) Communication Mode Signing 17 (35%) 14 (30%) No Signing 31 (65%) 32 (70%) Hearing Device Cochlear Implant Stratum 28 (58%) 24 (52%) Hearing Aid Stratum 20 (42%) 22 (48%) Newborn Hearing Screening Results Pass 2 (4%) 2 (4%) Fail 45 (94%) 43 (94%) Unknown 1 (2%) 1 (2%) Hearing Level – PTA4 Better Ear Slight (16 – 25 dB) 2 (4%) 1 (2%) Mild (26 – 40 dB) 9 (19%) 9 (20%) Moderate (41 – 55 dB) 9 (19%) 3 (7%) Moderately-Severe (56 – 70 dB) 5 (10%) 11 (24%) Severe (71 – 90 dB) 6 (12%) 7 (15%) Profound (>90 dB) 17 (35%) 14 (30%) Unknown 0 (0%) 1 (2%) Sex * Male 34 (71%) 20 (43%) Female 14 (29%) 26 (57%) Race Native American or Alaska Native 1 (2%) 0 (0%) Asian 3 (6%) 5 (11%) Black 1 (2%) 4 (9%) White 39 (81%) 30 (65%) More than one race 2 (4%) 6 (13%) Other 0 (0%) 1 (2%) Prefer not to answer 2 (4%) 0 (0%) Ethnicity Hispanic or Latinx 8 (17%) 7 (15%) Not Hispanic or Latinx 38 (79%) 39 (85%) Prefer not to answer 2 (4%) 0 (0%) Open in a new tab * P < .05. Notes: All ages are presented in months. Table 2. Parent and Household Baseline Assessment and Demographic Variables. Control (n = 48) PMI (n = 46) Parent and Household Variables M (SD) M (SD) Parent Strategy Use 3.0 (0.5) 3.1 (0.4) n (%) n (%) Relationship to Child Mother 43 (89%) 43 (93%) Father 5 (11%) 3 (6%) Education High school graduate 1 (2%) 1 (2%) Special training after high school 0 (0%) 1 (2%) Some college 10 (21%) 6 (13%) College graduate 21 (44%) 15 (33%) Graduate/professional training or above 16 (33%) 23 (50%) Employment Status Stay-at-home parent 13 (27%) 12 (26%) Employed part-time 9 (19%) 8 (18%) Employed full-time 26 (54%) 25 (54%) Student 0 (0%) 1 (2%) Receiving Government Assistance Yes 9 (19%) 7 (15%) No 39 (81%) 39 (85%) Geographic Region Urban 11 (20%) 9 (23%) Suburban 31 (70%) 32 (65%) Rural 6 (11%) 5 (12%) Race Native American or Alaska Native 0 (0%) 0 (0%) Asian 2 (4%) 5 (11%) Black 1 (2%) 4 (9%) White 40 (83%) 31 (67%) More than one race 1 (2%) 1 (2%) Other 0 (0%) 3 (7%) Prefer not to answer 4 (8%) 2 (4%) Ethnicity Hispanic or Latinx 7 (15%) 6 (13%) Not Hispanic or Latinx 37 (77%) 40 (87%) Prefer not to answer 4 (8%) 0 (0%) Use of Second Language Never (0% of the time) 36 (75%) 32 (70%) Rarely (Less than 25% of the time) 9 (19%) 9 (20%) Sometimes (25–50% of the time) 3 (6%) 1 (2%) Often (More than 50% of the time) 0 (0%) 3 (6%) Always (100% of the time) 0 (0%) 1 (2%) Open in a new tab Intervention Components Parents in the PMI group completed weekly intervention sessions via Zoom for 6 months. Interventionists included 4 research clinicians (1 developmental therapist and 3 speech-language pathologists) trained to fidelity on all intervention procedures. The first intervention session included a guided conversation to discuss goals, expectations, and the intervention format. The subsequent intervention sessions followed a Teach-Model-Coach-Review framework modified for telehealth, as outlined below. 46 All parents, regardless of their child’s communication mode, received the same instructional approach. Parents were encouraged to implement the strategies using the communication mode of their choosing. These sessions included 2 phases: (a) active learning and (b) review. Throughout the active learning phase, parents learned 7 communication support strategies (see Table S5 ). During each of the active learning sessions, the therapist explained the target communication support strategy (Teach), the therapist and parent reviewed 3 standardized clips of the strategy implementation (Model), the parent practiced using the strategy while receiving feedback from the therapist (Coach), and the therapist and parent reflected on the parent’s strategy use and discussed a plan to carryover the strategies during the week (Review). All parents learned the strategies individually in the following sequence: setting the stage, play and engage, respond and wait, notice and say, show it, contrast it, and add on. 47 – 49 A minimum of 2 sessions dedicated to active instruction of each strategy was required. Parents advanced to the subsequent strategy after demonstrating proficient strategy use for 2 consecutive sessions. The therapist determined proficient strategy use after watching a 6-minute parent-child interaction before each session. Following 2 consecutive sessions of proficient strategy use, the therapist introduced the next strategy. Alternatively, the therapist could use their clinical judgment to override the advancement rule in order to support the parent’s learning. If clinically appropriate, the therapist may elect to advance to the next strategy prior to demonstrated proficiency or continue with the target strategy instruction despite already demonstrated proficiency. For example, after focusing on the “Respond and Wait” strategy for five consecutive sessions, the parent did not demonstrate proficient strategy use. Specifically, the parent continued to have difficulty responding to the child’s communication in a timely manner because she did not know what to say when responding to the child’s communication. The therapist elected to move to the next strategy, “Notice and Say” because it would provide the parent with information on what to say to the child when responding to their communication. This decision-making was implemented to align the pacing of the intervention in service of the parent’s overall learning. However, such decisions were only permitted after meeting the minimum requirement of 2 sessions dedicated to active instruction of the target strategy. Therefore, all parents received at least 2 sessions dedicated to each of the 7 communication support strategies. Following the active learning phase, parents advanced to the review phase. The length of the review phase varied based on parent progress through the active learning phase. During the review phase, parents reviewed and integrated all communication support strategies. Each session followed the Teach-Model-Coach-Review format as outlined above. However, during the model portion, parents reviewed the video recording of their pre-session 6-minute parent-child interaction. The therapist and parent reflected on the parent’s strategy use, identified areas of improvement, and selected a focus for the session. Therapist’s fidelity of instruction was 0.95 for 20% of all intervention sessions, which were evaluated by research clinicians trained on intervention and fidelity scoring procedures. Outcomes Assessments were completed in the participant’s home via Zoom. Standardized assessments kits, an iPad (cellular-enabled, as needed), a tripod, and a Bluetooth headset were mailed to all participants. At all timepoints, assessors and coders were naïve to group allocation. A trained research clinician with extensive experience coding behavioral interactions and working with DHH children led the team of behavioral coders. Coders included undergraduate research assistants, master’s student in speech-language pathology, and research clinicians. Prior to coding, all coders achieved 80% reliability on 3 consecutive coding attempts of master reliability videos. To monitor ongoing reliability, 20% of assessments were coded a second time by a master coder. Parent Strategy Use Parent strategy use was measured at baseline (T0), monthly during intervention (T1 - T6), and immediately post-intervention (T7) during a 12-minute parent-child interaction. Parents were instructed to play with their own toys or an activity of their choice and interact with their child as they normally would. Interactions were recorded and later coded for 13 items that pertained to the subcomponents of the 7 communication support strategies (see Table S5 ). Coders reviewed the recording 2 times. First, coders attended to the parent and child’s overall interaction, play, and communication and rated items pertaining to the first 3 communication support strategies (setting the stage, play and engage, and respond and wait). Second, coders attended to the nuances of the parent’s language use and rated items pertaining to the remaining 4 communication support strategies (notice and say, show it, contrast it, and add on). Items were rated on a 5-point scale with higher scores indicating a stronger proficiency of strategy use (1 = Novice, 5 = Expert; ICC = 0.79). Items were averaged to yield a single composite score. The full coding manual is available upon request. Early Communication Indicator (ECI) Children’s communication was measured at baseline (T0), monthly during intervention (T1-T6), and immediately post-intervention (T7) during a 10-minute parent-child interaction. Parents were instructed to play with a standardized set of toys appropriate for the child’s age and interact with their child as they normally would. Interactions were recorded and later coded using the ECI, which reflects the frequency and complexity of the child’s functional communication during naturalistic interactions. 50 After recording the interaction, the assessor would note the use of sign in the assessment log. All ECI coders were directed to review a website of the most common signs and practiced identifying signs and sign approximations using standardized training videos. If the interaction included more than the most common signs, the parent or child was combining signs or using ASL, the assessor would flag the interaction to be coded by a fluent ASL user. A developmental therapist fluent in ASL would transcribe the interaction and the transcript would be coded by an ECI coder. Coding for all interactions followed the ECI coding manual. As such, each child utterance was coded for the presence of key skill elements that reflect prelinguistic and linguistic communication. These include gestures and vocalizations as well as single word utterances and multiple word utterances (both signed and/or spoken). The frequency of each communicative act was weighted to account for the hierarchy of skill complexity. Gestures and vocalizations were given 1 point, single words were given 2 points, and multiple-word utterances were given 3 points to yield a total weighted score (ICC = 0.98). Communication and Symbolic Behavior Scales – Developmental Profile (CSBS) Children’s communication was also measured at baseline (T0) and immediately post-intervention (T7) using the CSBS. The assessment was conducted by the parent with virtual coaching from a research clinician via a Bluetooth headset. All assessment administration procedures were conducted in accordance with the administration guidelines outlined in the CSBS manual. During the assessment, children were presented with 6 different activities designed to elicit pre-symbolic communication. The interaction was recorded and later scored for 20 items across 7 communication scales (emotion and eye gaze, communication, gestures, sounds, words, understand, and object use). The weighted raw scores for each of the 7 scales were grouped into 3 clusters (social, speech, and symbolic) and combined into a total raw score (ICC = 0.97). Prior to virtually coaching a parent through the administration of the CSBS, all research clinicians achieved 80% fidelity on 3 consecutive administrations. To monitor ongoing fidelity, 20% of all CSBS samples were scored for adherence to the protocol. Assessors’ average coaching fidelity was 0.97, and parents’ average administration fidelity was 0.95. Statistical Methods All statistical models were fit within a structural equation modeling (SEM) paradigm to estimate models using full information maximum likelihood (FIML), which provides unbiased estimation under common missingness mechanisms. Latent growth curve modeling was used to compare the growth of outcomes during intervention. Covariates included the child’s biological sex and age, which was mean centered. Maximum likelihood regressions were used to compare outcomes and test for moderation after intervention. Covariates included the child’s biological sex, the dependent variable before intervention, and the child’s age, which were mean centered. Heteroskedasticity was present in residuals for models including the ECI; thus, robust variance estimators were used in all models for methodological consistency. 51 Results Research Question 1a: Parent Strategy Use Outcomes During intervention, parent strategy use in the PMI group increased at a significantly greater rate than the control group (B = 0.08, SE = 0.02, P < .001). See Figure 2 . Directly after intervention, parent strategy use was significantly greater in the PMI group relative to the control group (B = 0.61, SE = 0.09, P < .001, d = 1.57). See Table 3 . FIGURE 2. Open in a new tab Growth of parent strategy use during intervention between groups. Table 3. Parent Strategy Use Outcomes During and After Intervention. Growth During Intervention Estimate SE P Parent Strategy Use Intercept (M = 2.97, SD = 0.32) Biological Sex −0.05 0.04 .26 Age at T0 −0.03 0.03 .25 Treatment Group 0.13 0.08 .11 Parent Strategy Use Slope (M = 0.01 SD = 0.04) Biological Sex 0.01 0.008 .15 Age at T0 0.002 0.004 .70 Treatment Group 0.08 0.02 < .001 Covariance of Intercept ~ Slope −0.01 0.004 .007 Robust Model Fit Statistics: χ 2 (49) = 79.89, P = 0.003; CFI = 0.90; TLI = 0.89; RMSEA = 0.09, 90% CI = (0.05, 0.12); SRMR = 0.08 Outcome After Intervention Estimate SE P Parent Strategy Use at T7 Intercept 3.09 0.06 < .001 Biological Sex 0.10 0.04 .02 Age at T0 −0.02 0.02 .45 Parent Strategy Use at T0 0.29 0.10 .005 Treatment Group 0.61 0.09 < .001 Model Fit: R 2 = 0.49 Open in a new tab Note: For all models, the dependent variable at T0 and the child’s age are mean centered. Biological Sex: Male = −1, Female = 1; Treatment Group: Control = 0, PMI = 1 Research Question 1b: Child Communication Outcomes During intervention, ECI weighted scores in the PMI group increased at a significantly greater rate than the control group (B = 3.16, SE = 1.47, P = .03). See Figure 3 . Directly after intervention, ECI weighted scores were significantly greater in the PMI group relative to the control group (B = 31.10, SE = 12.06, P = .01, d = 0.59). However, CSBS total raw scores did not significantly differ between the groups (B = 6.72, SE = 3.52, P = .06, d = 0.40). See Table 4 . FIGURE 3. Open in a new tab Growth of child ECI weighted scores during intervention between groups. Table 4. Child Communication Outcomes During and After Intervention. Growth During Intervention Estimate SE P ECI Weighted Score Intercept (M = 49.16, SD = 20.21) Biological Sex 5.008 2.95 .09 Age at T0 2.94 1.26 .20 Treatment Group 1.05 5.80 .86 ECI Weighted Score Slope (M = 5.26, SD = 4.88) Biological Sex 1.39 0.73 .06 Age at T0 −0.15 0.35 .66 Treatment Group 3.16 1.47 .03 Covariance of Intercept ~ Slope 65.17 20.71 .002 Robust Model Fit Statistics: χ 2 (49) = 65.39, P = .06; CFI = 0.97; TLI = 0.96; RMSEA = 0.06, 90% CI = (0.00, 0.10); SRMR = 0.07 Outcome After Intervention Estimate SE P ECI Weighted Score at T7 Intercept 78.58 8.02 < .001 Biological Sex 5.66 6.45 .38 Age at T0 −1.02 2.66 .70 ECI Weighted Score at T0 0.86 0.22 < .001 Treatment Group 31.10 12.06 .01 Model Fit: R 2 = 0.29 Estimate SE P CSBS Total Raw Score at T7 Intercept 95.21 2.82 < .001 Biological Sex 1.32 1.87 .48 Age at T0 −4.25 0.90 < .001 CSBS Total Raw Score at T0 0.86 0.07 < .001 Treatment Group 6.72 3.52 .06 Model Fit: R 2 = 0.64 Open in a new tab Note: For all models, the dependent variable at T0 and the child’s age are mean centered. Biological Sex: Male = −1, Female = 1; Treatment Group: Control = 0, PMI = 1 Research Question 2: Communication Mode Moderation The intervention effect on parent strategy use was large for both the no sign (d = 1.64) and sign subgroups (d = 1.52). Parent strategy use was not significantly moderated by communication mode (B = −0.05, SE = 0.18, P = .78). The intervention effect on ECI weighted scores was small for the no sign subgroup (d = 0.36) and large for the sign subgroup (d = 1.05). Communication mode did not significantly moderate the effect of the intervention on ECI weighted scores (B = 39.68, SE = 25.95, P = .13). The intervention effect on CSBS raw scores was negligible for the no sign subgroup (d = 0.09) and large for the sign subgroup (d = 1.09). Furthermore, communication mode significantly moderated the effect of the intervention on CSBS total raw scores (B = 18.93, SE = 8.09 P = .02). See Table 5 and Figure 4 . Table 5. Outcomes After Intervention Moderated by Communication Method. Outcome After Intervention Estimate SE P Parent Strategy Use at T7 Intercept 3.02 0.08 < .001 Biological Sex 0.10 0.04 .02 Age at T0 −0.02 0.02 .46 Parent Strategy Use at T0 0.26 0.10 .007 Treatment Group 0.64 0.11 < .001 Communication Mode 0.17 0.11 .12 Treatment Group*Communication Mode −0.05 0.18 .78 Model Fit: R 2 = 0.51 Estimate SE P ECI Weighted Score at T7 Intercept 90.66 9.31 < .001 Biological Sex 5.57 6.27 .37 Age at T0 −0.38 2.74 .89 ECI Weighted Score at T0 0.83 0.20 < .001 Treatment Group 16.90 13.37 .21 Communication Mode −32.54 13.61 .02 Treatment Group*Communication Mode 39.68 25.95 .13 Model Fit: R 2 = 0.32 Estimate SE P CSBS Total Raw Score at T7 Intercept 260.63 39.46 < .001 Biological Sex 1.36 1.72 .43 Age at T0 −3.88 0.90 < .001 CSBS Total Raw Score at T0 0.82 0.07 < .001 Treatment Group 0.27 3.33 .08 Communication Mode −13.22 6.03 .03 Treatment Group*Communication Mode 18.93 8.09 .02 Model Fit: R 2 = 0.67 Open in a new tab Note: For all models, the dependent variable at T0 and the child’s age are mean centered. Biological Sex: Male = −1, Female = 1; Treatment Group: Control = 0, PMI = 1; Communication Mode: No Signing = 0, Signing = 1. FIGURE 4. Open in a new tab Conditional means of CSBS total raw scores after intervention moderated by communication mode. Discussion Results of the first large-scale randomized clinical trial of an early communication intervention for DHH children suggest that the PMI is an efficacious approach to supporting DHH toddlers’ communication development. 18 , 25 By completing weekly, one-hour sessions for 6 months, parents learned to effectively implement communication support strategies that align with their DHH child’s language learning needs. Consequently, throughout the course of the intervention, growth in the frequency and complexity of child communication increased at a significantly greater rate for children enrolled in the intervention. Directly after intervention, child outcomes on the ECI were significantly greater for children in the PMI condition. Although differences in CSBS scores did not meet traditional levels of statistical significance ( P = .06), the intervention effect on CSBS scores was clinically significant (d = 0.40). The lack of a statistically significant effect is likely due to limitations in statistical power of the current clinical trial, rather than the true absence of an intervention effect on CSBS scores. Overall, the current clinical trial builds on an extensive body of literature demonstrating the positive effects of early intervention and high-quality parent input for DHH children. 18 – 24 , 26 , 27 , 33 , 34 Outcomes of the current study address a critical need for high-quality early interventions for DHH children and their families, which is highly relevant for clinical practice. The primary goal of a parent-mediated early intervention is to support the parent’s capacity to improve their child’s communication, thereby increasing family involvement and intervention dosage. Involving parents in early intervention is associated with a number of positive outcomes, including parent satisfaction with services, family well-being, parenting self-efficacy, and child developmental outcomes. 52 Consistent with outcomes of PMIs across clinical populations, 53 results of the current trial indicate robust parent outcomes (d = 1.57). In line with our expectations, as parents increased their use of communication support strategies, child communication improved. The immediate impact of parent strategy use on child outcomes may, however, vary depending on the child’s communication. The intervention effect on CSBS outcomes was significantly moderated by communication mode and although the moderation effect on ECI outcomes did not meet statistical significance ( P = .13), the pattern of results was consistent for both outcomes. Across all child outcomes, the intervention effect was greater for children exposed to sign relative to children not exposed to sign, indicating that the intervention was particularly effective for children exposed to sign. Future analyses will characterize the extent to which these effects remain long-term. Foremost, it is critical to contextualize the effects of the intervention based on the sample of children enrolled in the current study. All children enrolled in the study had at least one hearing parent and the majority of parents prioritized supporting their child’s spoken language development. While the prioritization of spoken language is not the goal of every family, it is in line with the principles of family-centered care mandated by IDEA Part C to consider how to facilitate families’ capacity to optimize outcomes of the language of their choosing. 38 , 54 , 55 In order to support their child’s acquisition of spoken language, some parents elected to expose their child to signs as well as speech. This is in contrast, and distinct from, natural sign language acquisition. As noted in Table S1 , the subgroup of children exposed to signs were exposed to sign-supported speech (SSS), whereby parents pair speech and signs to provide spoken language input, not a natural sign language such as American Sign Language (ASL). Thus, the extent to which these results generalize to ASL exposure is beyond the scope of the current study. To highlight this distinction, we discuss the implications of the current findings with respect to the use of sign to support spoken language acquisition. There are several explanations for the moderation effect, each with varying levels of support given the outcomes of the current study. Because communication mode was not randomly assigned, we initially considered whether the moderation effect was due to underlying differences between the two groups. For example, parents may elect to use sign language with children who may benefit from additional support to acquire spoken language. Except there were no differences across a number of key variables (e.g., hearing levels, auditory behaviors) and the analyses controlled for baseline communication, age, and biological sex. Additionally, parents in both subgroups learned to use the strategies to an equal degree and, even so, the intervention was more beneficial for the sign subgroup. This may indicate that the intervention was especially necessary for children whose parents elected to use sign, however, the underlying reason for this differentiated benefit is unclear. These results highlight the need to understand individual differences across parent-child dyads that may influence intervention outcomes. We then considered the effect of using sign to support spoken language acquisition, as visual input may supplement reduced auditory access. Yet, children exposed to sign in the control group scored the lowest across child outcomes. It is then reasonable to consider that using sign in addition to the taught communication support strategies is uniquely facilitative of child communication. However, children in the PMI group exposed to sign did not significantly outperform children not exposed to sign. Given these conflicting results and the fact that communication mode was not randomly assigned, we cannot determine the precise mechanism through which signing in isolation or in conjunction with the current intervention affects child communication. In order to further elucidate the unique and interactive effect of sign and the PMI, a future trial that actively manipulates the use of sign as a component of the intervention is necessary. Despite the strengths of the current study, there are several limitations. One limitation is the difference in biological sex between groups, though its impact is likely minimal because analyses controlled for biological sex. Additionally, recruitment began in March 2020 during the onset of the COVID-19 pandemic, therefore, we modified our protocol to conduct the study via telehealth. This approach had many advantages including the ability to maintain service delivery throughout the pandemic and increase access to families nationwide but required adaptations, such as virtual assessment administration. Given the excellent fidelity of coaching and parent administration, it is unlikely that the modified administration had a significant impact on the study results. While the study recruited a nationwide sample of DHH families, the sample had limited racial and cultural diversity. Future studies may consider the extent to which the intervention effects generalize to a diverse, representative sample of DHH families. To this end, future research may also address how the current intervention may be modified with particular consideration of the values, preferences, and goals of each family. Finally, at this stage in the intervention development, it was critical to design a foundational set of strategies that were feasible and appropriate for parents to implement. Only 2 of the 46 families in the intervention condition discontinued intervention, which may reflect the feasibility and acceptability of the current PMI. Feasibility of the current intervention may be further improved by isolating which strategies work best and for whom. Conclusion As there is a paucity of evidence-based early interventions for DHH children, 18 these results have immediate implications for clinical practice that fall into two broad categories: instructional approaches to support parent outcomes and communication support strategies to facilitate child outcomes. First, the instructional approach implemented as part of the PMI was effective in facilitating parent’s use of strategies. Given the robust literature on caregiver coaching these findings were expected, 53 , 56 yet nonetheless, they confirm that the effect of this instructional approach extends to parents of DHH children. It is also noteworthy that such effects were observed in the context of a telehealth model for parent coaching. Second, on average, the communication support strategies embedded in the PMI were effective in facilitating child communication outcomes. The intervention effect was significantly greater for children exposed to signs, indicating that it is essential to consider communication modality within the development and evaluation of early communication interventions for DHH children. The current study is a first step toward the implementation of evidence-based early communication interventions designed to maximize language outcomes for DHH children. Supplementary Material Supplemental Materials NIHMS2093041-supplement-Supplemental_Materials.docx (50.8KB, docx) What’s Known on This Subject Although advances in early identification and hearing technology have improved outcomes for deaf/hard of hearing children, these children continue to have poorer language outcomes than their hearing peers. Developing effective early communication interventions is critical to maximizing long-term language outcomes. What This Study Adds The current study is the first large-scale randomized clinical trial of a communication intervention for deaf/hard of hearing toddlers. Results support the efficacy of a parent-mediated communication intervention, which has significant implications for clinical practice. Acknowledgements We would like to recognize the families that participated in the study and the contributions from the Early Intervention Research Group at Northwestern University. We would also like to acknowledge that research reported in this publication was supported in its entirety by the National Institute of Deafness and Other Communication Disorders of the National Institutes of Health under award number (R01DC016877, awarded to Megan Y. Roberts). The NIH had no role in the design and conduct of the study. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. Funding/Support: Research reported in this publication was supported in its entirety by the National Institute of Deafness and Other Communication Disorders of the National Institutes of Health under award number: R01DC016877. Role of Funder/Sponsor: The NIH had no role in the design and conduct of the study. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. Abbreviations: ASL American Sign Language CSBS Communication and Symbolic Behavior Scales ECI Early Communication Indicator DHH Deaf/hard of hearing D-LEAT Deaf and Hard of Hearing Language Exposure Assessment Tool PMI Parent-Mediated Intervention SSS Sign-supported speech Footnotes Conflict of Interest Disclosures: The authors have no conflicts of interest to disclose. Clinical Trial Registration : NCT03803943 , clinicaltrials.gov . Data and associated documentation is available to users only under a data-sharing agreement that provides for a commitment: (1) to use the data only for research purposes and not to identify any individual participant; (2) to secure the data using appropriate computer technology; (3) to destroy or return the data after analyses are completed; and (4) to cite the grant and key publications describing the database and measures in any resulting presentations and publications. With a signed data access agreement, deidentified participant data, data dictionaries, and statistical code will be shared. No participant personally identifiable information will be shared for any purpose. Requests for a data access agreement can be made by completing the data request form at the following link: https://redcap.nubic.northwestern.edu/redcap/surveys/?s=PFKELWJ7JA9KEF43 . References 1. Niparko JK, Tobey EA, Thal DJ, et al. Spoken language development in children following cochlear implantation. JAMA. 2010;303(15):1498–1506. doi: 10.1001/jama.2010.451 [ DOI ] [ PMC free article ] [ PubMed ] [ Google Scholar ] 2. Tomblin JB, Oleson JJ, Ambrose SE, Walker E, Moeller MP. The influence of hearing aids on the speech and language development of children with hearing loss. JAMA Otolaryngol Head Neck Surg. 2014;140(5):403–409. doi: 10.1001/jamaoto.2014.267 [ DOI ] [ PMC free article ] [ PubMed ] [ Google Scholar ] 3. Antia SD, Lederberg AR, Easterbrooks S, et al. 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