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.
COMPLETED
PHASE2
105 participants
Change from Baseline to Month 7
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
| 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
| 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
| 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 7Population: 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
| 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 7Population: 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
| 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 7Population: 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
| 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 24Population: 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
| 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 24Total 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 24Population: 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
| 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 24Population: 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
| 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
No Intervention - Business-as-usual control: Children
Parent-Implemented Communication Intervention (PICT): Parents
No Intervention - Business-as-usual control: Parents
Serious adverse events
Adverse event data not reported
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place