Optimizing Outcomes for Young Autistic Children
Optimizing Outcomes Through Sequencing Parent-Mediated Interventions for Young Children With Autism
1 other identifier
interventional
184
1 country
1
Brief Summary
The overarching goal of the proposed study is to: (a) determine how best to sequence two parent-mediated interventions: a social communication intervention (Project ImPACT, Improving Parents as Communication Teachers) and a disruptive behavior intervention (Parent Training for Disruptive Behavior) and (b) examine moderators and mediators of intervention outcomes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2023
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 7, 2023
CompletedFirst Posted
Study publicly available on registry
July 3, 2023
CompletedStudy Start
First participant enrolled
July 11, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 28, 2027
January 29, 2026
January 1, 2026
3.6 years
June 7, 2023
January 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Observed Child Social Communication
The child's observed social communication is measured from a caregiver-child interaction in which the dyad interacts across a variety of daily activities using materials in their home. This interaction will be recorded and coded for the child's social communication using the codebook from the Early Communication Indicator assessment.
Between 25-30 weeks
Observed Child Disruptive Behavior
The child's disruptive behavior is measured from a caregiver-child interaction in which the dyad interacts across a variety of daily activities using materials in their home. This interaction will be recorded and coded for the child's disruptive behavior using the Disruptive Behavior Diagnostic Observation (DB-DOS) codebook.
Between 25-30 weeks
Caregiver Report of Child Social Communication
The caregiver's assessment of the child's social communication is measured from the Developmental Profile 4 (DP-4) Social-Emotional and Communication Scales. This assessment will yield a total raw score ranging from 0 (minimum) to 70 (maximum), with higher scores indicating better outcomes.
Between 25-30 weeks
Caregiver Report of Child Disruptive Behavior
The caregiver's assessment of the child's disruptive behavior is measured from the Eyberg Child Behavior Inventory.
Between 25-30 weeks
Family Life Impairment Scale
Family life participation outcomes are measured using the Family Life Impairment Scale. The measure's values range from 0 (minimum) to 38 (maximum) with higher scores indicating worse outcomes.
Between 25-30 weeks
Secondary Outcomes (2)
Caregiver Satisfaction
Between 25-30 weeks
Caregiver Perceived Stress
Between 25-30 weeks
Study Arms (6)
Social Communication + Reduce Frequency
ACTIVE COMPARATORStarting Intervention: Social Communication Who: Parent \& Child \& Therapist Frequency: 1-hour twice/week Secondary Intervention: "Reduce Frequency" of Social Communication Intervention Intervention: Social Communication Who: Parent \& Child \& Therapist Reduce Frequency: 1-hour once/week
Social Communication + Add Tools
ACTIVE COMPARATORStarting Intervention: Social Communication Who: Parent \& Child \& Therapist Frequency: 1-hour twice/week Secondary Intervention: "Add Tools" to Social Communication Intervention Intervention: Social Communication Who: Parent \& Child \& Therapist Frequency: 1-hour twice/week Add: Video feedback
Social Communication + Switch Intervention to Disruptive Behavior
ACTIVE COMPARATORStarting Intervention: Social Communication Who: Parent \& Child \& Therapist Frequency: 1-hour twice/week Secondary Intervention: Switch to Disruptive Behavior Intervention Who: Parent \& Therapist only Frequency: 1-hour once/week
Disruptive Behavior + Reduce Frequency
ACTIVE COMPARATORStarting Intervention: Disruptive Behavior Who: Parent \& Therapist only Frequency: 1-hour once/week Secondary Intervention: "Reduce Frequency" of Disruptive Behavior Intervention Intervention: Disruptive Behavior Who: Parent \& Therapist only Reduce Frequency: 1-hour every other week
Disruptive Behavior + Add Tools
ACTIVE COMPARATORStarting Intervention: Disruptive Behavior Who: Parent \& Therapist only Frequency: 1-hour once/week Secondary Intervention: "Add Tools" to Disruptive Behavior Intervention Intervention: Disruptive Behavior Who: Parent \& Therapist \& Child Frequency: 1-hour once/week Add: Video feedback
Disruptive Behavior + Switch Intervention to Social Communication
ACTIVE COMPARATORStarting Intervention: Disruptive Behavior Who: Parent \& Therapist only Frequency: 1-hour once/week Secondary Intervention: "Switch" to Social Communication Intervention Who: Parent \& Child \& Therapist Frequency: 1-hour twice/week
Interventions
Intervention: Social Communication Who: Parent \& Child \& Therapist Frequency: 1-hour once/week
Intervention: Disruptive Behavior Who: Parent \& Therapist only Frequency: 1-hour once/week
Intervention: Social Communication Who: Parent \& Child \& Therapist Frequency: 1-hour twice/week
Intervention: Disruptive Behavior Who: Parent \& Therapist only Frequency: 1-hour once/week
Intervention: Social Communication Who: Parent \& Child \& Therapist Frequency: 1-hour twice/week
Intervention: Disruptive Behavior Who: Parent \& Therapist only Frequency: 1-hour every other week
Eligibility Criteria
You may qualify if:
- Child is between 18 and 48 months old
- Child scores above the research cutoff for ASD on the TELE-ASD-PEDS
- Child has no other known diagnosis or disability at study entry
- Child has normal vision
- Child is exposed to English at least 50% of the time
- Child has a caregiver willing to learn the intervention strategies
- Caregiver wants help supporting their child's social communication and behavior regulation
- Caregiver understands conversational English well enough to participate in caregiver instruction
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Northwestern Universitylead
- University of Texas at Austincollaborator
Study Sites (1)
Northwestern University
Evanston, Illinois, 60208, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Outcome coders will be blind to experimental condition
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 7, 2023
First Posted
July 3, 2023
Study Start
July 11, 2023
Primary Completion (Estimated)
February 28, 2027
Study Completion (Estimated)
February 28, 2027
Last Updated
January 29, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Data will be shared once the first published article is available. Data will be available for 10 years.
We will share the final dataset in two ways: the National Database for Autism Research (NDAR) and the Inter-University Consortium for Political and Social Research (ICPSR).