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A Trial of Project ImPACT in Early Intervention

A Randomized Trial of Project ImPACT, an Evidence-based Intervention for Infants and Toddlers With Autism Spectrum Disorder

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04729127
Enrollment
79
Registered
2021-01-28
Start date
2020-06-11
Completion date
2022-08-31
Last updated
2025-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism Spectrum Disorder

Brief summary

Our pilot study will address a number of pressing questions, including: Can community clinicians successfully coach parents of children with ASD in evidence-based practice to achieve positive outcomes for their children and themselves? What dose is necessary to achieve change? And what is the cost effectiveness of implementing evidence-based interventions at different doses?

Detailed description

The investigators will partner with 6 of Philadelphias 13 agencies serving young children with ASD. The investigators will enroll 3 clinicians per agency (18 total) and 3 families per clinician (54 total). Agencies will be randomized to the 3 arms. The investigators will measure clinician fidelity and parent fidelity through direct observation and selfreport. The investigators will measure child and parent outcomes at baseline and 6 months using measures common to similar trials. Resource use for the economic evaluation will occur quarterly and will take a societal approach. The investigators will partner with a community advisory board to apply the findings from this pilot trial to the development of a larger, system-wide subsequent trial that is feasible and ecologically valid for Philadelphias EI system. The results will provide rigorous information about whether evidence-based autism interventions for young children can be implemented successfully with the resources available in cities like Philadelphia, the role of hours of treatment in improving child outcomes, and the cost-benefit implications for families and community agencies. This project has the potential to dramatically improve the services families of young children with ASD in Philadelphia receive, and significantly improve their long-term outcomes. This preliminary trial would provide the EI system with the information needed to bring this type of intervention to scale across the entire system. It also would serve as the foundation for an application for federal funds to conduct a system-wide study of Project ImPACT as implemented in all Philadelphia agencies serving children with ASD.

Interventions

BEHAVIORALProject ImPACT

Project ImPACT (Improving Parents As Communication Teachers) is an evidence-based parent-mediated intervention program based on best practices in early intervention. The program is designed for young children up to age six with social communication delays, including autism spectrum disorder. Project ImPACT focuses on social engagement, language, social imitation, and play. Project ImPACT is a naturalistic developmental behavioral intervention (NDBI).

Sponsors

Michigan State University
CollaboratorOTHER
University of Pennsylvania
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 30 Months
Healthy volunteers
No

Inclusion criteria

1. child is \<30 months of age (to receive 6 months of intervention) 2. a classification of autism or high autism risk as determined by the EI system; 3. receive early intervention services through the infant and toddler program; and 4. parent is willing to complete the parent measures that are part of this study.

Exclusion criteria

1\) be over 30 months of age

Design outcomes

Primary

MeasureTime frameDescription
Vineland Adaptive Behavior Scales 3rd Edition-Socialization Domain6 monthsThe Vineland-3 is a standardized measure of adaptive behavior--the things that people do to function in their everyday lives. Because it is a norm-based instrument, the examinee's adaptive functioning is compared to that of others his or her age. The ABC score is based on scores for three specific adaptive behavior domains: Communication, Daily Living Skills, and Socialization. The domain scores are also expressed as standard scores with a mean of 100 and standard deviation of 15. The standard score range for the Socialization domain is 20-140. Higher scores indicate better outcomes.
Vineland Adaptive Behavior Scales 3rd Edition-Communication DomainTime 1 (Baseline) and Time 3 (6 Month Follow Up) for a total of 6 months.The Vineland-3 is a standardized measure of adaptive behavior--the things that people do to function in their everyday lives. Because it is a norm-based instrument, the examinee's adaptive functioning is compared to that of others his or her age. The ABC score is based on scores for three specific adaptive behavior domains: Communication, Daily Living Skills, and Socialization. The domain scores are also expressed as standard scores with a mean of 100 and standard deviation of 15. The standard score range for the Communication domain is 20-140. Higher scores indicate better outcomes.
Brief Observation of Social Communication Change (BOSCC)Baseline and 6 Month Follow Up (Exit) (6 months)The BOSCC is a measure of treatment-response for social-communication behaviors. The BOSCC contains 12 items in total. The score range of individual items is 0-5. Items are then summed to a total score. The range for a total score is 0-60. Higher scores are an indication of more symptom severity.
Early Intervention Parenting Self-Efficacy Scale (EIPSES)Baseline and 6 Month Follow Up (6 months)The EIPSES is a measure of parent self-efficacy. It is a 16-item self-report measure that examines parents beliefs about their ability to produce positive changes and promote optimal development in their child with a disability. Once items are summed, the total score ranges from 16-112, with higher scores indicating better self-efficacy and empowerment.
Parenting Interactions With Children: Checklist of Observations Linked to Outcomes (PICCOLO)Collected at Baseline and 6 Month Follow Up (time frame: 6 months)Parent Responsiveness is measured using the Parenting Interactions with Children: Checklist of Observations Linked to Outcomes (PICCOLO™). PICCOLO is a checklist of 29 observable developmentally supportive parenting behaviors, with children ages 10-47 months, in four domains (affection, responsiveness, encouragement, and teaching). Each item is scored as 0, 1 or 2. 0 = Behavior absent, not observed 1. = Behavior barely there, sometimes 2. = Behavior seen often Assessors add scores for each item to calculate a domain score and an overall domain score. Total scores can range from 0-58, with higher scores indicating more parent responsiveness to child behavior and actions.
Project ImPACT Intervention Fidelity Checklist6 monthsParent Treatment Adherence will be assessed through a videotaped parent-child interaction at home. Parent behavior will be scored for use of the intervention strategies using the Project ImPACT Intervention Fidelity Checklist. The scores range from 1 to 5, the higher the score representing the most adherence to the Project ImPACT intervention. The overall score is an average of scores from each item.
Project ImPACT Coaching Fidelity Checklist3 Month Follow-Up (3 month time frame)Clinician fidelity is measured using the Project ImPACT Coaching Fidelity Checklist. The checklist measures the providers' use of the core components to Project ImPACT. The form uses a 3-point score (scored from 0-2): 0, Not observed; 1, partially observed; and 2, observed. The final score is a summary percentage rating of overall fidelity with a range of 0-100%.

Secondary

MeasureTime frameDescription
Parent Empowerment and Coaching in Early Intervention (PEACE) Caregiver Coaching Fidelity Tool3 Month Follow Up (3 Months)The PEACE Fidelity Tool measures a provider's caregiver coaching quality by evaluating the quality and use of evidence based caregiver coaching strategies during recorded EI session across 5 domains (collaboration, daily routines, demonstration, practice and feedback, and reflection). The tool consists of 25 items scored on a 5 point scale from 1-5. Domains and total scores are calculated by averaging items. Scores can range from 1-5, with higher scores indicating better coaching competency and quality.

Countries

United States

Participant flow

Pre-assignment details

Parent/Children dyads were enrolled in the study and counted as 1 family. The total number includes the number of individual parents and children enrolled together as a dyad and individual early intervention providers that were enrolled.

Participants by arm

ArmCount
Treatment as Usual: Children
The families keep receiving their treatment as usual
18
Treatment as Usual: Early Interventionists
Early interventionists provide treatment and services as usual.
6
Treatment as Usual: Caregivers
The families keep receiving their treatment as usual
18
ImPACT at a Dose of 1 Hour/Week: Children
ImPACT at a dose of 1 hour/week over 6 months Project ImPACT: Project ImPACT (Improving Parents As Communication Teachers) is an evidence-based parent-mediated intervention program based on best practices in early intervention. The program is designed for young children up to age six with social communication delays, including autism spectrum disorder. Project ImPACT focuses on social engagement, language, social imitation, and play. Project ImPACT is a naturalistic developmental behavioral intervention (NDBI).
23
ImPACT at a Dose of 1 Hour/Week: Early Interventionists
Early Interventionists provide ImPACT at a dose of 1 hour/week over 6 months with at least 3 families on their caseload. Project ImPACT: Project ImPACT (Improving Parents As Communication Teachers) is an evidence-based parent-mediated intervention program based on best practices in early intervention. The program is designed for young children up to age six with social communication delays, including autism spectrum disorder. Project ImPACT focuses on social engagement, language, social imitation, and play. Project ImPACT is a naturalistic developmental behavioral intervention (NDBI).
6
ImPACT at a Dose of 1 Hour/Week: Caregivers
ImPACT at a dose of 1 hour/week over 6 months Project ImPACT: Project ImPACT (Improving Parents As Communication Teachers) is an evidence-based parent-mediated intervention program based on best practices in early intervention. The program is designed for young children up to age six with social communication delays, including autism spectrum disorder. Project ImPACT focuses on social engagement, language, social imitation, and play. Project ImPACT is a naturalistic developmental behavioral intervention (NDBI).
23
ImPACT at 4 Hours/Week: Children
ImPACT at 4 hours/week over 6 months. Project ImPACT: Project ImPACT (Improving Parents As Communication Teachers) is an evidence-based parent-mediated intervention program based on best practices in early intervention. The program is designed for young children up to age six with social communication delays, including autism spectrum disorder. Project ImPACT focuses on social engagement, language, social imitation, and play. Project ImPACT is a naturalistic developmental behavioral intervention (NDBI).
20
ImPACT at 4 Hours/Week: Early Interventionists
Early Interventionists provide ImPACT at a dose of 4 hours/week over 6 months with at least 3 families on their caseload. Project ImPACT: Project ImPACT (Improving Parents As Communication Teachers) is an evidence-based parent-mediated intervention program based on best practices in early intervention. The program is designed for young children up to age six with social communication delays, including autism spectrum disorder. Project ImPACT focuses on social engagement, language, social imitation, and play. Project ImPACT is a naturalistic developmental behavioral intervention (NDBI).
6
ImPACT at 4 Hours/Week: Caregivers
ImPACT at 4 hours/week over 6 months. Project ImPACT: Project ImPACT (Improving Parents As Communication Teachers) is an evidence-based parent-mediated intervention program based on best practices in early intervention. The program is designed for young children up to age six with social communication delays, including autism spectrum disorder. Project ImPACT focuses on social engagement, language, social imitation, and play. Project ImPACT is a naturalistic developmental behavioral intervention (NDBI).
20
Total140

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003FG004FG005FG006FG007FG008
Overall StudySuspended/Terminated EI Services404606202
Overall StudySwitched Agency/Setting101101101
Overall StudyWithdrawal by Subject101000000

Baseline characteristics

CharacteristicTotalTreatment as Usual: CaregiversImPACT at a Dose of 1 Hour/Week: ChildrenTreatment as Usual: Early InterventionistsImPACT at a Dose of 1 Hour/Week: Early InterventionistsImPACT at a Dose of 1 Hour/Week: CaregiversImPACT at 4 Hours/Week: ChildrenImPACT at 4 Hours/Week: Early InterventionistsTreatment as Usual: ChildrenImPACT at 4 Hours/Week: Caregivers
Age, Categorical
<=18 years
61 Participants0 Participants23 Participants0 Participants0 Participants0 Participants20 Participants0 Participants18 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
79 Participants18 Participants0 Participants6 Participants6 Participants23 Participants0 Participants6 Participants0 Participants20 Participants
Age, Continuous10.74 years
STANDARD_DEVIATION 16.48
28.9 years
STANDARD_DEVIATION 5.9
1.86 years
STANDARD_DEVIATION 0.48
42.4 years
STANDARD_DEVIATION 9.66
42.2 years
STANDARD_DEVIATION 9.24
32.0 years
STANDARD_DEVIATION 7.2
2.02 years
STANDARD_DEVIATION 0.26
39.5 years
STANDARD_DEVIATION 8.71
1.92 years
STANDARD_DEVIATION 0.42
35.8 years
STANDARD_DEVIATION 9.6
Race (NIH/OMB)
American Indian or Alaska Native
4 Participants1 Participants1 Participants1 Participants0 Participants0 Participants0 Participants0 Participants1 Participants0 Participants
Race (NIH/OMB)
Asian
6 Participants1 Participants1 Participants0 Participants0 Participants1 Participants1 Participants0 Participants1 Participants1 Participants
Race (NIH/OMB)
Black or African American
61 Participants6 Participants9 Participants1 Participants3 Participants12 Participants10 Participants2 Participants9 Participants9 Participants
Race (NIH/OMB)
More than one race
11 Participants3 Participants2 Participants0 Participants0 Participants4 Participants1 Participants0 Participants0 Participants1 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
2 Participants1 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants1 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
16 Participants1 Participants3 Participants1 Participants0 Participants0 Participants5 Participants0 Participants1 Participants5 Participants
Race (NIH/OMB)
White
40 Participants5 Participants7 Participants3 Participants3 Participants6 Participants3 Participants4 Participants5 Participants4 Participants
Region of Enrollment
United States
140 participants18 participants23 participants6 participants6 participants23 participants20 participants6 participants18 participants20 participants
Sex: Female, Male
Female
38 Participants0 Participants6 Participants4 Participants6 Participants0 Participants8 Participants6 Participants8 Participants0 Participants
Sex: Female, Male
Male
41 Participants0 Participants17 Participants2 Participants0 Participants0 Participants12 Participants0 Participants10 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
EG004
affected / at risk
EG005
affected / at risk
EG006
affected / at risk
EG007
affected / at risk
EG008
affected / at risk
deaths
Total, all-cause mortality
0 / 180 / 60 / 230 / 60 / 200 / 60 / 180 / 230 / 20
other
Total, other adverse events
0 / 180 / 60 / 230 / 60 / 200 / 60 / 180 / 230 / 20
serious
Total, serious adverse events
0 / 180 / 60 / 230 / 60 / 200 / 60 / 180 / 230 / 20

Outcome results

Primary

Brief Observation of Social Communication Change (BOSCC)

The BOSCC is a measure of treatment-response for social-communication behaviors. The BOSCC contains 12 items in total. The score range of individual items is 0-5. Items are then summed to a total score. The range for a total score is 0-60. Higher scores are an indication of more symptom severity.

Time frame: Baseline and 6 Month Follow Up (Exit) (6 months)

Population: Participants in the arms/groups Treatment as Usual: Early Interventionists, ImPACT at a Dose of 1 Hour/Week: Early Interventionists, ImPACT at 4 Hours/Week: Early Interventionists, Treatment as Usual: Caregivers, ImPACT at a Dose of 1 Hour/Week: Caregivers, ImPACT at 4 Hours/Week: Caregivers are not included in the analysis as the measure's intent is to assess child outcomes.

ArmMeasureGroupValue (MEAN)Dispersion
Treatment as UsualBrief Observation of Social Communication Change (BOSCC)Baseline35.6 score on a scaleStandard Deviation 29.2
Treatment as UsualBrief Observation of Social Communication Change (BOSCC)Follow-Up29.2 score on a scaleStandard Deviation 10.3
ImPACT at a Dose of 1 Hour/WeekBrief Observation of Social Communication Change (BOSCC)Baseline36.6 score on a scaleStandard Deviation 8.5
ImPACT at a Dose of 1 Hour/WeekBrief Observation of Social Communication Change (BOSCC)Follow-Up34.8 score on a scaleStandard Deviation 10.3
ImPACT at 4 Hours/WeekBrief Observation of Social Communication Change (BOSCC)Baseline37.0 score on a scaleStandard Deviation 8.8
ImPACT at 4 Hours/WeekBrief Observation of Social Communication Change (BOSCC)Follow-Up36.2 score on a scaleStandard Deviation 5.6
Comparison: See protocol for full statistical analysis plan.p-value: 0.04Regression, Linear
Comparison: See protocol for full statistical analysis plan.p-value: 0.02Regression, Linear
Primary

Early Intervention Parenting Self-Efficacy Scale (EIPSES)

The EIPSES is a measure of parent self-efficacy. It is a 16-item self-report measure that examines parents beliefs about their ability to produce positive changes and promote optimal development in their child with a disability. Once items are summed, the total score ranges from 16-112, with higher scores indicating better self-efficacy and empowerment.

Time frame: Baseline and 6 Month Follow Up (6 months)

Population: Participants in the arms/groups Treatment as Usual: Early Interventionists, ImPACT at a Dose of 1 Hour/Week: Early Interventionists, ImPACT at 4 Hours/Week: Early Interventionists, Treatment as Usual: Children, ImPACT at a Dose of 1 Hour/Week: Children, ImPACT at 4 Hours/Week: Children are not included in the analysis as the measure's intent is to assess parent outcomes.

ArmMeasureGroupValue (MEAN)Dispersion
Treatment as UsualEarly Intervention Parenting Self-Efficacy Scale (EIPSES)Follow-Up87.5 score on a scaleStandard Deviation 9.1
Treatment as UsualEarly Intervention Parenting Self-Efficacy Scale (EIPSES)Baseline87.3 score on a scaleStandard Deviation 9.7
ImPACT at a Dose of 1 Hour/WeekEarly Intervention Parenting Self-Efficacy Scale (EIPSES)Baseline84.8 score on a scaleStandard Deviation 9.4
ImPACT at a Dose of 1 Hour/WeekEarly Intervention Parenting Self-Efficacy Scale (EIPSES)Follow-Up89.4 score on a scaleStandard Deviation 12.2
ImPACT at 4 Hours/WeekEarly Intervention Parenting Self-Efficacy Scale (EIPSES)Baseline87.74 score on a scaleStandard Deviation 6.14
ImPACT at 4 Hours/WeekEarly Intervention Parenting Self-Efficacy Scale (EIPSES)Follow-Up89.95 score on a scaleStandard Deviation 9.98
Comparison: See protocol for full statistical analysis plan.p-value: 0.78Regression, Linear
Comparison: See protocol for full statistical analysis plan.p-value: 0.89Regression, Linear
Primary

Parenting Interactions With Children: Checklist of Observations Linked to Outcomes (PICCOLO)

Parent Responsiveness is measured using the Parenting Interactions with Children: Checklist of Observations Linked to Outcomes (PICCOLO™). PICCOLO is a checklist of 29 observable developmentally supportive parenting behaviors, with children ages 10-47 months, in four domains (affection, responsiveness, encouragement, and teaching). Each item is scored as 0, 1 or 2. 0 = Behavior absent, not observed 1. = Behavior barely there, sometimes 2. = Behavior seen often Assessors add scores for each item to calculate a domain score and an overall domain score. Total scores can range from 0-58, with higher scores indicating more parent responsiveness to child behavior and actions.

Time frame: Collected at Baseline and 6 Month Follow Up (time frame: 6 months)

Population: Participants in the arms/groups Treatment as Usual: Early Interventionists, ImPACT at a Dose of 1 Hour/Week: Early Interventionists, ImPACT at 4 Hours/Week: Early Interventionists, Treatment as Usual: Children, ImPACT at a Dose of 1 Hour/Week: Children, ImPACT at 4 Hours/Week: Children are not included in the analysis as the measure's intent is to assess parent outcomes.

ArmMeasureGroupValue (MEAN)Dispersion
Treatment as UsualParenting Interactions With Children: Checklist of Observations Linked to Outcomes (PICCOLO)Baseline35.5 total score on a scaleStandard Deviation 2.27
Treatment as UsualParenting Interactions With Children: Checklist of Observations Linked to Outcomes (PICCOLO)Follow-Up41.3 total score on a scaleStandard Deviation 2.24
ImPACT at a Dose of 1 Hour/WeekParenting Interactions With Children: Checklist of Observations Linked to Outcomes (PICCOLO)Baseline40.2 total score on a scaleStandard Deviation 2.1
ImPACT at a Dose of 1 Hour/WeekParenting Interactions With Children: Checklist of Observations Linked to Outcomes (PICCOLO)Follow-Up36.8 total score on a scaleStandard Deviation 3.18
ImPACT at 4 Hours/WeekParenting Interactions With Children: Checklist of Observations Linked to Outcomes (PICCOLO)Baseline38.0 total score on a scaleStandard Deviation 2.67
ImPACT at 4 Hours/WeekParenting Interactions With Children: Checklist of Observations Linked to Outcomes (PICCOLO)Follow-Up40.8 total score on a scaleStandard Deviation 2.57
Comparison: See protocol for full statistical analysis plan.p-value: 0.07Regression, Linear
Comparison: See protocol for full statistical analysis plan.p-value: 0.88Regression, Linear
Primary

Project ImPACT Coaching Fidelity Checklist

Clinician fidelity is measured using the Project ImPACT Coaching Fidelity Checklist. The checklist measures the providers' use of the core components to Project ImPACT. The form uses a 3-point score (scored from 0-2): 0, Not observed; 1, partially observed; and 2, observed. The final score is a summary percentage rating of overall fidelity with a range of 0-100%.

Time frame: 3 Month Follow-Up (3 month time frame)

Population: Treatment as Usual providers did not implement Project ImPACT and were not evaluated using this fidelity measure. Participants in the arms/groups Treatment as Usual: Families, ImPACT at a Dose of 1 Hour/Week: Families, ImPACT at 4 Hours/Week: Families are not included in the analysis as the measure's intent is to assess the provider's adherence to the intervention. Parent adherence to the intervention was assessed with a separate measure.

ArmMeasureValue (MEAN)Dispersion
ImPACT at a Dose of 1 Hour/WeekProject ImPACT Coaching Fidelity Checklist55 percentage of fidelityStandard Deviation 21
ImPACT at 4 Hours/WeekProject ImPACT Coaching Fidelity Checklist59 percentage of fidelityStandard Deviation 24
Primary

Project ImPACT Intervention Fidelity Checklist

Parent Treatment Adherence will be assessed through a videotaped parent-child interaction at home. Parent behavior will be scored for use of the intervention strategies using the Project ImPACT Intervention Fidelity Checklist. The scores range from 1 to 5, the higher the score representing the most adherence to the Project ImPACT intervention. The overall score is an average of scores from each item.

Time frame: 6 months

Population: Treatment as Usual Children/Caregivers didn't receive the Project ImPACT intervention and not evaluated for their adherence to it. Participants in the arms/groups Treatment as Usual: Early Interventionists, ImPACT at a Dose of 1 Hour/Week: Early Interventionists, ImPACT at 4 Hours/Week: Early Interventionists are not included in the analysis as the measure's intent is to assess caregiver adherence to the intervention. A separate measure was used to evaluate interventionist's adherence.

ArmMeasureValue (MEAN)Dispersion
ImPACT at a Dose of 1 Hour/WeekProject ImPACT Intervention Fidelity Checklist2.8 score on a scaleStandard Deviation 0.6
ImPACT at 4 Hours/WeekProject ImPACT Intervention Fidelity Checklist3.2 score on a scaleStandard Deviation 0.7
Primary

Vineland Adaptive Behavior Scales 3rd Edition-Communication Domain

The Vineland-3 is a standardized measure of adaptive behavior--the things that people do to function in their everyday lives. Because it is a norm-based instrument, the examinee's adaptive functioning is compared to that of others his or her age. The ABC score is based on scores for three specific adaptive behavior domains: Communication, Daily Living Skills, and Socialization. The domain scores are also expressed as standard scores with a mean of 100 and standard deviation of 15. The standard score range for the Communication domain is 20-140. Higher scores indicate better outcomes.

Time frame: Time 1 (Baseline) and Time 3 (6 Month Follow Up) for a total of 6 months.

Population: Participants in the arms/groups Treatment as Usual: Early Interventionists, ImPACT at a Dose of 1 Hour/Week: Early Interventionists, ImPACT at 4 Hours/Week: Early Interventionists, Treatment as Usual: Caregivers, ImPACT at a Dose of 1 Hour/Week: Caregivers, and ImPACT at 4 Hours/Week: Caregivers are not included in the analysis as the measure's intent is to assess child outcomes.

ArmMeasureGroupValue (MEAN)Dispersion
Treatment as UsualVineland Adaptive Behavior Scales 3rd Edition-Communication DomainBaseline69.4 units on a scaleStandard Deviation 15.2
Treatment as UsualVineland Adaptive Behavior Scales 3rd Edition-Communication DomainFollow-Up69.4 units on a scaleStandard Deviation 15.7
ImPACT at a Dose of 1 Hour/WeekVineland Adaptive Behavior Scales 3rd Edition-Communication DomainBaseline65.2 units on a scaleStandard Deviation 14
ImPACT at a Dose of 1 Hour/WeekVineland Adaptive Behavior Scales 3rd Edition-Communication DomainFollow-Up61.4 units on a scaleStandard Deviation 21.6
ImPACT at 4 Hours/WeekVineland Adaptive Behavior Scales 3rd Edition-Communication DomainBaseline63.4 units on a scaleStandard Deviation 18
ImPACT at 4 Hours/WeekVineland Adaptive Behavior Scales 3rd Edition-Communication DomainFollow-Up54.9 units on a scaleStandard Deviation 18.4
Comparison: See protocol for full statistical analysis plan.p-value: 0.79Regression, Linear
Comparison: See protocol for full statistical analysis plan.p-value: 0.27Regression, Linear
Primary

Vineland Adaptive Behavior Scales 3rd Edition-Socialization Domain

The Vineland-3 is a standardized measure of adaptive behavior--the things that people do to function in their everyday lives. Because it is a norm-based instrument, the examinee's adaptive functioning is compared to that of others his or her age. The ABC score is based on scores for three specific adaptive behavior domains: Communication, Daily Living Skills, and Socialization. The domain scores are also expressed as standard scores with a mean of 100 and standard deviation of 15. The standard score range for the Socialization domain is 20-140. Higher scores indicate better outcomes.

Time frame: 6 months

Population: Participants in the arms/groups Treatment as Usual: Early Interventionists, ImPACT at a Dose of 1 Hour/Week: Early Interventionists, ImPACT at 4 Hours/Week: Early Interventionists, Treatment as Usual: Caregivers, ImPACT at a Dose of 1 Hour/Week: Caregivers, and ImPACT at 4 Hours/Week: Caregivers are not included in the analysis as the measure's intent is to assess child outcomes.

ArmMeasureGroupValue (MEAN)Dispersion
Treatment as UsualVineland Adaptive Behavior Scales 3rd Edition-Socialization DomainBaseline84.3 score on a scaleStandard Deviation 12.2
Treatment as UsualVineland Adaptive Behavior Scales 3rd Edition-Socialization DomainFollow-Up78.7 score on a scaleStandard Deviation 14.4
ImPACT at a Dose of 1 Hour/WeekVineland Adaptive Behavior Scales 3rd Edition-Socialization DomainBaseline76.4 score on a scaleStandard Deviation 12.8
ImPACT at a Dose of 1 Hour/WeekVineland Adaptive Behavior Scales 3rd Edition-Socialization DomainFollow-Up74.2 score on a scaleStandard Deviation 19
ImPACT at 4 Hours/WeekVineland Adaptive Behavior Scales 3rd Edition-Socialization DomainBaseline75.6 score on a scaleStandard Deviation 15
ImPACT at 4 Hours/WeekVineland Adaptive Behavior Scales 3rd Edition-Socialization DomainFollow-Up70.1 score on a scaleStandard Deviation 14.3
Comparison: See protocol for full statistical analysis plan.p-value: 0.26Regression, Linear
Comparison: See protocol for full statistical analysis plan.p-value: 0.74Regression, Linear
Secondary

Parent Empowerment and Coaching in Early Intervention (PEACE) Caregiver Coaching Fidelity Tool

The PEACE Fidelity Tool measures a provider's caregiver coaching quality by evaluating the quality and use of evidence based caregiver coaching strategies during recorded EI session across 5 domains (collaboration, daily routines, demonstration, practice and feedback, and reflection). The tool consists of 25 items scored on a 5 point scale from 1-5. Domains and total scores are calculated by averaging items. Scores can range from 1-5, with higher scores indicating better coaching competency and quality.

Time frame: 3 Month Follow Up (3 Months)

Population: Participants in the arms/groups Treatment as Usual: Families, ImPACT at a Dose of 1 Hour/Week: Families, ImPACT at 4 Hours/Week: Families are not included in the analysis as the measure's intent is to assess provider coaching fidelity.

ArmMeasureValue (MEAN)Dispersion
Treatment as UsualParent Empowerment and Coaching in Early Intervention (PEACE) Caregiver Coaching Fidelity Tool2.8 units on a scaleStandard Deviation 0.6
ImPACT at a Dose of 1 Hour/WeekParent Empowerment and Coaching in Early Intervention (PEACE) Caregiver Coaching Fidelity Tool2.7 units on a scaleStandard Deviation 0.4
ImPACT at 4 Hours/WeekParent Empowerment and Coaching in Early Intervention (PEACE) Caregiver Coaching Fidelity Tool2.6 units on a scaleStandard Deviation 0.7

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026