Trial Outcomes & Findings for Early Communication Intervention for Toddlers With Hearing Loss (NCT NCT03803943)

NCT ID: NCT03803943

Last Updated: 2025-10-15

Results Overview

Parent use of communication support strategies was measured from a 12-minute parent-child interaction in which the dyad plays using a standard set of toys. Interactions were video recorded and coded for 13 items representing subcomponents of seven communication support strategies. Each item was rated on a 5-point scale (1 = novice use, 5 = expert use), reflecting the quality and proficiency of parent strategy use. Items were averaged to yield a Total Composite Score (Min = 1, Max = 5), with higher scores indicating more proficient and consistent use of communication strategies.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

105 participants

Primary outcome timeframe

Change from Baseline to Month 7

Results posted on

2025-10-15

Participant Flow

Randomization occurred at the dyad level, with each dyad consisting of one parent and one child. The dyad was considered the enrolled unit in the study, and each dyad was randomly assigned to either the intervention or control group. The arm/group title is labeled based on the dyad's assignment and reflects the joint participation of both caregiver and child.

Participant milestones

Participant milestones
Measure
Parent-Implemented Communication Intervention (PICT) - Children
Participants assigned to the PICT condition will receive weekly hour long intervention sessions in their home for 6 months. Parents will learn four sets of communication support strategies: (a) visual (e.g., modeling language within the child's line of sight), (b) interactive (e.g., following the child's attentional focus), (c) responsive (e.g., responding to all communicative attempts), and (d) linguistically stimulating (e.g., modeling language targets, expanding child communication). Parent-Implemented Communication Intervention (PICT): Weekly hour long intervention sessions for 6 months
No Intervention - Business-as-usual control - Children
Participants assigned to the BAU control group will not receive the PICT intervention. No Intervention - Business-as-usual control: Does not receive PICT intervention
Parent-Implemented Communication Intervention (PICT) - Parents
Participants assigned to the PICT condition will receive weekly hour long intervention sessions in their home for 6 months. Parents will learn four sets of communication support strategies: (a) visual (e.g., modeling language within the child's line of sight), (b) interactive (e.g., following the child's attentional focus), (c) responsive (e.g., responding to all communicative attempts), and (d) linguistically stimulating (e.g., modeling language targets, expanding child communication). Parent-Implemented Communication Intervention (PICT): Weekly hour long intervention sessions for 6 months
No Intervention - Business-as-usual control - Parents
Participants assigned to the BAU control group will not receive the PICT intervention. No Intervention - Business-as-usual control: Does not receive PICT intervention
Overall Study
STARTED
48
46
48
46
Overall Study
COMPLETED
46
44
46
44
Overall Study
NOT COMPLETED
2
2
2
2

Reasons for withdrawal

Reasons for withdrawal
Measure
Parent-Implemented Communication Intervention (PICT) - Children
Participants assigned to the PICT condition will receive weekly hour long intervention sessions in their home for 6 months. Parents will learn four sets of communication support strategies: (a) visual (e.g., modeling language within the child's line of sight), (b) interactive (e.g., following the child's attentional focus), (c) responsive (e.g., responding to all communicative attempts), and (d) linguistically stimulating (e.g., modeling language targets, expanding child communication). Parent-Implemented Communication Intervention (PICT): Weekly hour long intervention sessions for 6 months
No Intervention - Business-as-usual control - Children
Participants assigned to the BAU control group will not receive the PICT intervention. No Intervention - Business-as-usual control: Does not receive PICT intervention
Parent-Implemented Communication Intervention (PICT) - Parents
Participants assigned to the PICT condition will receive weekly hour long intervention sessions in their home for 6 months. Parents will learn four sets of communication support strategies: (a) visual (e.g., modeling language within the child's line of sight), (b) interactive (e.g., following the child's attentional focus), (c) responsive (e.g., responding to all communicative attempts), and (d) linguistically stimulating (e.g., modeling language targets, expanding child communication). Parent-Implemented Communication Intervention (PICT): Weekly hour long intervention sessions for 6 months
No Intervention - Business-as-usual control - Parents
Participants assigned to the BAU control group will not receive the PICT intervention. No Intervention - Business-as-usual control: Does not receive PICT intervention
Overall Study
Withdrawal by Subject
2
2
2
2

Baseline Characteristics

This is a baseline measure of the child participants only.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Parent-Implemented Communication Intervention (PICT): Children
n=46 Participants
Participants assigned to the PICT condition will receive weekly hour long intervention sessions in their home for 6 months. Parents will learn four sets of communication support strategies: (a) visual (e.g., modeling language within the child's line of sight), (b) interactive (e.g., following the child's attentional focus), (c) responsive (e.g., responding to all communicative attempts), and (d) linguistically stimulating (e.g., modeling language targets, expanding child communication). Parent-Implemented Communication Intervention (PICT): Weekly hour long intervention sessions for 6 months
No Intervention - Business-as-usual control: Children
n=48 Participants
Participants assigned to the BAU control group will not receive the PICT intervention. No Intervention - Business-as-usual control: Does not receive PICT intervention
Parent-Implemented Communication Intervention (PICT): Parents
n=46 Participants
Participants assigned to the PICT condition will receive weekly hour long intervention sessions in their home for 6 months. Parents will learn four sets of communication support strategies: (a) visual (e.g., modeling language within the child's line of sight), (b) interactive (e.g., following the child's attentional focus), (c) responsive (e.g., responding to all communicative attempts), and (d) linguistically stimulating (e.g., modeling language targets, expanding child communication). Parent-Implemented Communication Intervention (PICT): Weekly hour long intervention sessions for 6 months
No Intervention - Business-as-usual control: Parents
n=48 Participants
Participants assigned to the BAU control group will not receive the PICT intervention. No Intervention - Business-as-usual control: Does not receive PICT intervention
Total
n=188 Participants
Total of all reporting groups
Age, Continuous
15.6 months
STANDARD_DEVIATION 1.8 • n=46 Participants • This is a baseline measure of the child participants only.
15.5 months
STANDARD_DEVIATION 2.1 • n=48 Participants • This is a baseline measure of the child participants only.
15.6 months
STANDARD_DEVIATION 1.9 • n=94 Participants • This is a baseline measure of the child participants only.
Sex: Female, Male
Female
26 Participants
n=46 Participants
34 Participants
n=48 Participants
43 Participants
n=46 Participants
43 Participants
n=48 Participants
146 Participants
n=188 Participants
Sex: Female, Male
Male
20 Participants
n=46 Participants
14 Participants
n=48 Participants
3 Participants
n=46 Participants
5 Participants
n=48 Participants
42 Participants
n=188 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
7 Participants
n=46 Participants
8 Participants
n=48 Participants
6 Participants
n=46 Participants
7 Participants
n=48 Participants
28 Participants
n=188 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
39 Participants
n=46 Participants
38 Participants
n=48 Participants
40 Participants
n=46 Participants
37 Participants
n=48 Participants
154 Participants
n=188 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=46 Participants
2 Participants
n=48 Participants
0 Participants
n=46 Participants
4 Participants
n=48 Participants
6 Participants
n=188 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=46 Participants
1 Participants
n=48 Participants
0 Participants
n=46 Participants
0 Participants
n=48 Participants
1 Participants
n=188 Participants
Race (NIH/OMB)
Asian
5 Participants
n=46 Participants
3 Participants
n=48 Participants
5 Participants
n=46 Participants
2 Participants
n=48 Participants
15 Participants
n=188 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=46 Participants
0 Participants
n=48 Participants
0 Participants
n=46 Participants
0 Participants
n=48 Participants
0 Participants
n=188 Participants
Race (NIH/OMB)
Black or African American
4 Participants
n=46 Participants
1 Participants
n=48 Participants
4 Participants
n=46 Participants
1 Participants
n=48 Participants
10 Participants
n=188 Participants
Race (NIH/OMB)
White
30 Participants
n=46 Participants
39 Participants
n=48 Participants
31 Participants
n=46 Participants
40 Participants
n=48 Participants
140 Participants
n=188 Participants
Race (NIH/OMB)
More than one race
6 Participants
n=46 Participants
2 Participants
n=48 Participants
1 Participants
n=46 Participants
1 Participants
n=48 Participants
10 Participants
n=188 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants
n=46 Participants
2 Participants
n=48 Participants
5 Participants
n=46 Participants
4 Participants
n=48 Participants
12 Participants
n=188 Participants
Total Number of Communicative Acts from the Language Sample - Child
54.7 Total Weighted Frequency Score
STANDARD_DEVIATION 30.0 • n=46 Participants • This is a baseline measure of the child participants only.
49.0 Total Weighted Frequency Score
STANDARD_DEVIATION 32.6 • n=48 Participants • This is a baseline measure of the child participants only.
51.8 Total Weighted Frequency Score
STANDARD_DEVIATION 31.3 • n=94 Participants • This is a baseline measure of the child participants only.
Communication and Symbolic Behavior Scales Score - Child
67.5 units on a scale
STANDARD_DEVIATION 24.7 • n=46 Participants • This is a baseline measure of the child participants only.
58.7 units on a scale
STANDARD_DEVIATION 23.6 • n=48 Participants • This is a baseline measure of the child participants only.
63.0 units on a scale
STANDARD_DEVIATION 24.4 • n=94 Participants • This is a baseline measure of the child participants only.
Use of Communication Support Strategies - Parent
3.10 units on a scale
STANDARD_DEVIATION 0.40 • n=46 Participants • This is a baseline measure of the parent participants only.
3.0 units on a scale
STANDARD_DEVIATION 0.40 • n=48 Participants • This is a baseline measure of the parent participants only.
3.10 units on a scale
STANDARD_DEVIATION .50 • n=94 Participants • This is a baseline measure of the parent participants only.
Hearing Level - Child
slight
1 Participants
n=46 Participants • This is a baseline measure of the child participants only.
2 Participants
n=48 Participants • This is a baseline measure of the child participants only.
3 Participants
n=94 Participants • This is a baseline measure of the child participants only.
Hearing Level - Child
mild
9 Participants
n=46 Participants • This is a baseline measure of the child participants only.
9 Participants
n=48 Participants • This is a baseline measure of the child participants only.
18 Participants
n=94 Participants • This is a baseline measure of the child participants only.
Hearing Level - Child
moderate
3 Participants
n=46 Participants • This is a baseline measure of the child participants only.
9 Participants
n=48 Participants • This is a baseline measure of the child participants only.
12 Participants
n=94 Participants • This is a baseline measure of the child participants only.
Hearing Level - Child
moderately severe
11 Participants
n=46 Participants • This is a baseline measure of the child participants only.
5 Participants
n=48 Participants • This is a baseline measure of the child participants only.
16 Participants
n=94 Participants • This is a baseline measure of the child participants only.
Hearing Level - Child
severe
7 Participants
n=46 Participants • This is a baseline measure of the child participants only.
6 Participants
n=48 Participants • This is a baseline measure of the child participants only.
13 Participants
n=94 Participants • This is a baseline measure of the child participants only.
Hearing Level - Child
profound
14 Participants
n=46 Participants • This is a baseline measure of the child participants only.
17 Participants
n=48 Participants • This is a baseline measure of the child participants only.
31 Participants
n=94 Participants • This is a baseline measure of the child participants only.
Hearing Level - Child
unknown
1 Participants
n=46 Participants • This is a baseline measure of the child participants only.
0 Participants
n=48 Participants • This is a baseline measure of the child participants only.
1 Participants
n=94 Participants • This is a baseline measure of the child participants only.
Communication Mode - Child
Sign
14 Participants
n=46 Participants • This is a baseline measure of the child participants only.
17 Participants
n=48 Participants • This is a baseline measure of the child participants only.
31 Participants
n=94 Participants • This is a baseline measure of the child participants only.
Communication Mode - Child
No Sign
32 Participants
n=46 Participants • This is a baseline measure of the child participants only.
31 Participants
n=48 Participants • This is a baseline measure of the child participants only.
63 Participants
n=94 Participants • This is a baseline measure of the child participants only.
Hearing Device - Child
Cochlear Implant/Bone Conduction
24 Participants
n=46 Participants • This is a baseline measure of the child participants only.
28 Participants
n=48 Participants • This is a baseline measure of the child participants only.
52 Participants
n=94 Participants • This is a baseline measure of the child participants only.
Hearing Device - Child
Hearing Aid
22 Participants
n=46 Participants • This is a baseline measure of the child participants only.
20 Participants
n=48 Participants • This is a baseline measure of the child participants only.
42 Participants
n=94 Participants • This is a baseline measure of the child participants only.

PRIMARY outcome

Timeframe: Change from Baseline to Month 7

Population: This is an outcome measure of the parent participants only.

Parent use of communication support strategies was measured from a 12-minute parent-child interaction in which the dyad plays using a standard set of toys. Interactions were video recorded and coded for 13 items representing subcomponents of seven communication support strategies. Each item was rated on a 5-point scale (1 = novice use, 5 = expert use), reflecting the quality and proficiency of parent strategy use. Items were averaged to yield a Total Composite Score (Min = 1, Max = 5), with higher scores indicating more proficient and consistent use of communication strategies.

Outcome measures

Outcome measures
Measure
Parent-Implemented Communication Intervention (PICT): Parents
n=46 Participants
Participants assigned to the PICT condition will receive weekly hour long intervention sessions in their home for 6 months. Parents will learn four sets of communication support strategies: (a) visual (e.g., modeling language within the child's line of sight), (b) interactive (e.g., following the child's attentional focus), (c) responsive (e.g., responding to all communicative attempts), and (d) linguistically stimulating (e.g., modeling language targets, expanding child communication). Parent-Implemented Communication Intervention (PICT): Weekly hour long intervention sessions for 6 months
No Intervention - Business-as-usual control: Parents
n=48 Participants
Participants assigned to the BAU control group will not receive the PICT intervention. No Intervention - Business-as-usual control: Does not receive PICT intervention
Use of Communication Support Strategies - Parent
.60 units on a scale
Standard Deviation .52
.02 units on a scale
Standard Deviation .51

PRIMARY outcome

Timeframe: Change from Baseline to Month 7

Population: This is an outcome measure of the child participants only.

During the 10-minute interaction, the child played with toys and wordless picture books. A research assistant transcribed and coded all communicative acts. Each communicative act was assigned a weight reflecting its developmental complexity: gestures and vocalizations = 1 point, single words = 2 points, and multiple-word utterances = 3 points. The Total Weighted Frequency Score (Min = 0, Max = NA) is the sum of the weighted frequency of each act, with higher scores reflecting more frequent and complex communicative acts.

Outcome measures

Outcome measures
Measure
Parent-Implemented Communication Intervention (PICT): Parents
n=46 Participants
Participants assigned to the PICT condition will receive weekly hour long intervention sessions in their home for 6 months. Parents will learn four sets of communication support strategies: (a) visual (e.g., modeling language within the child's line of sight), (b) interactive (e.g., following the child's attentional focus), (c) responsive (e.g., responding to all communicative attempts), and (d) linguistically stimulating (e.g., modeling language targets, expanding child communication). Parent-Implemented Communication Intervention (PICT): Weekly hour long intervention sessions for 6 months
No Intervention - Business-as-usual control: Parents
n=48 Participants
Participants assigned to the BAU control group will not receive the PICT intervention. No Intervention - Business-as-usual control: Does not receive PICT intervention
Total Number of Communicative Acts From the Language Sample - Child
57.8 Total Weighted Frequency Score
Standard Deviation 57.8
25.24 Total Weighted Frequency Score
Standard Deviation 50.1

PRIMARY outcome

Timeframe: Month 7

Population: This is an outcome measure of the child participants only.

The child is presented with 6 different activities (wind-up toy, balloon, bubbles, jar, books, play) designed to elicit child communication. The interaction is video recorded and then scored for 20 items across 7 communication scales (emotion and eye gaze, communication, gestures, sounds, words, understanding, 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 (min = 0; max = 113). Higher scores indicate better skills.

Outcome measures

Outcome measures
Measure
Parent-Implemented Communication Intervention (PICT): Parents
n=46 Participants
Participants assigned to the PICT condition will receive weekly hour long intervention sessions in their home for 6 months. Parents will learn four sets of communication support strategies: (a) visual (e.g., modeling language within the child's line of sight), (b) interactive (e.g., following the child's attentional focus), (c) responsive (e.g., responding to all communicative attempts), and (d) linguistically stimulating (e.g., modeling language targets, expanding child communication). Parent-Implemented Communication Intervention (PICT): Weekly hour long intervention sessions for 6 months
No Intervention - Business-as-usual control: Parents
n=48 Participants
Participants assigned to the BAU control group will not receive the PICT intervention. No Intervention - Business-as-usual control: Does not receive PICT intervention
Communication and Symbolic Behavior Scales Score - Child
104.98 units on a scale
Standard Deviation 24.49
92.24 units on a scale
Standard Deviation 29.61

SECONDARY outcome

Timeframe: Change from Baseline to Month 24

Population: This is an outcome measure of the parent participants only.

Parent use of communication support strategies was measured from a 12-minute parent-child interaction in which the dyad plays using a standard set of toys. Interactions were video recorded and coded for 13 items representing subcomponents of seven communication support strategies. Each item was rated on a 5-point scale (1 = novice use, 5 = expert use), reflecting the quality and proficiency of parent strategy use. Items were averaged to yield a Total Composite Score (Min = 1, Max = 5), with higher scores indicating more proficient and consistent use of communication strategies.

Outcome measures

Outcome measures
Measure
Parent-Implemented Communication Intervention (PICT): Parents
n=46 Participants
Participants assigned to the PICT condition will receive weekly hour long intervention sessions in their home for 6 months. Parents will learn four sets of communication support strategies: (a) visual (e.g., modeling language within the child's line of sight), (b) interactive (e.g., following the child's attentional focus), (c) responsive (e.g., responding to all communicative attempts), and (d) linguistically stimulating (e.g., modeling language targets, expanding child communication). Parent-Implemented Communication Intervention (PICT): Weekly hour long intervention sessions for 6 months
No Intervention - Business-as-usual control: Parents
n=48 Participants
Participants assigned to the BAU control group will not receive the PICT intervention. No Intervention - Business-as-usual control: Does not receive PICT intervention
Use of Communication Support Strategies - Parent
.30 units on a scale
Standard Deviation .59
.09 units on a scale
Standard Deviation .58

SECONDARY outcome

Timeframe: Change from Baseline to Month 24

Total number of spoken words will be collected using two measures that will be combined used confirmatory factory analysis. Total Number of Words Said from the MacArthur-Bates Communicative Development Inventory: Words and Sentences and the total number of different spoken word roots from a 10-minute language sample in which an assessor plays with the child following a standardized protocol.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Month 24

Population: This is an outcome measure of the child participants only.

The child is presented with different receptive tasks, such as following simple directions and pointing to pictures, until the child provides an incorrect response to six consecutive items. A total standard score is calculated based on the raw score and the child's age (min = 50; max = 150). Higher score indicate better outcomes.

Outcome measures

Outcome measures
Measure
Parent-Implemented Communication Intervention (PICT): Parents
n=46 Participants
Participants assigned to the PICT condition will receive weekly hour long intervention sessions in their home for 6 months. Parents will learn four sets of communication support strategies: (a) visual (e.g., modeling language within the child's line of sight), (b) interactive (e.g., following the child's attentional focus), (c) responsive (e.g., responding to all communicative attempts), and (d) linguistically stimulating (e.g., modeling language targets, expanding child communication). Parent-Implemented Communication Intervention (PICT): Weekly hour long intervention sessions for 6 months
No Intervention - Business-as-usual control: Parents
n=48 Participants
Participants assigned to the BAU control group will not receive the PICT intervention. No Intervention - Business-as-usual control: Does not receive PICT intervention
Expressive Communication Standard Score on the Preschool Language Scale - 5th Edition - Child
100.44 units on a scale
Standard Deviation 20.05
93.81 units on a scale
Standard Deviation 20.45

SECONDARY outcome

Timeframe: Month 24

Population: This is an outcome measure of the child participants only.

The child is presented with different expressive tasks, such as labeling pictures, until the child provides an incorrect response to six consecutive items. A total standard score is calculated based on the raw score and the child's age (min = 50; max = 150). Higher Scores indicate better outcomes.

Outcome measures

Outcome measures
Measure
Parent-Implemented Communication Intervention (PICT): Parents
n=46 Participants
Participants assigned to the PICT condition will receive weekly hour long intervention sessions in their home for 6 months. Parents will learn four sets of communication support strategies: (a) visual (e.g., modeling language within the child's line of sight), (b) interactive (e.g., following the child's attentional focus), (c) responsive (e.g., responding to all communicative attempts), and (d) linguistically stimulating (e.g., modeling language targets, expanding child communication). Parent-Implemented Communication Intervention (PICT): Weekly hour long intervention sessions for 6 months
No Intervention - Business-as-usual control: Parents
n=48 Participants
Participants assigned to the BAU control group will not receive the PICT intervention. No Intervention - Business-as-usual control: Does not receive PICT intervention
Auditory Comprehension Standard Score on the Preschool Language Scale - 5th Edition - Child
102.46 units on a scale
Standard Deviation 20.27
92.14 units on a scale
Standard Deviation 23.8

Adverse Events

Parent-Implemented Communication Intervention (PICT): Children

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

No Intervention - Business-as-usual control: Children

Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths

Parent-Implemented Communication Intervention (PICT): Parents

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

No Intervention - Business-as-usual control: Parents

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Parent-Implemented Communication Intervention (PICT): Children
n=46 participants at risk
Participants assigned to the PICT condition will receive weekly hour long intervention sessions in their home for 6 months. Parents will learn four sets of communication support strategies: (a) visual (e.g., modeling language within the child's line of sight), (b) interactive (e.g., following the child's attentional focus), (c) responsive (e.g., responding to all communicative attempts), and (d) linguistically stimulating (e.g., modeling language targets, expanding child communication). Parent-Implemented Communication Intervention (PICT): Weekly hour long intervention sessions for 6 months
No Intervention - Business-as-usual control: Children
n=48 participants at risk
Participants assigned to the BAU control group will not receive the PICT intervention. No Intervention - Business-as-usual control: Does not receive PICT intervention
Parent-Implemented Communication Intervention (PICT): Parents
n=46 participants at risk
Participants assigned to the PICT condition will receive weekly hour long intervention sessions in their home for 6 months. Parents will learn four sets of communication support strategies: (a) visual (e.g., modeling language within the child's line of sight), (b) interactive (e.g., following the child's attentional focus), (c) responsive (e.g., responding to all communicative attempts), and (d) linguistically stimulating (e.g., modeling language targets, expanding child communication). Parent-Implemented Communication Intervention (PICT): Weekly hour long intervention sessions for 6 months
No Intervention - Business-as-usual control: Parents
n=48 participants at risk
Participants assigned to the BAU control group will not receive the PICT intervention. No Intervention - Business-as-usual control: Does not receive PICT intervention
Psychiatric disorders
Crying
0.00%
0/46 • Monthly over 18 months
2.1%
1/48 • Number of events 1 • Monthly over 18 months
0.00%
0/46 • Monthly over 18 months
0.00%
0/48 • Monthly over 18 months

Additional Information

Megan Roberts

Northwestern University

Phone: (847) 491-3066

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place