NCT05926687 · Northwestern University
Optimizing Outcomes for Young Autistic Children
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
Social Communication
Intervention: Social Communication Who: Parent \& Child \& Therapist Frequency: 1-hour twice/week
BEHAVIORAL
Disruptive Behavior
Intervention: Disruptive Behavior Who: Parent \& Therapist only Frequency: 1-hour once/week
BEHAVIORAL
Social Communication + Reduce Frequency
Intervention: Social Communication Who: Parent \& Child \& Therapist Frequency: 1-hour once/week
BEHAVIORAL
Social Communication + Add Tools
Intervention: Social Communication Who: Parent \& Child \& Therapist Frequency: 1-hour twice/week
BEHAVIORAL
Disruptive Behavior + Reduce Frequency
Intervention: Disruptive Behavior Who: Parent \& Therapist only Frequency: 1-hour every other week
BEHAVIORAL
Disruptive Behavior + Add Tools
Intervention: Disruptive Behavior Who: Parent \& Therapist only Frequency: 1-hour once/week
Primary outcome measures
Observed Child Social Communication
Time frame: Between 25-30 weeks
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.
Observed Child Disruptive Behavior
Time frame: Between 25-30 weeks
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.
Caregiver Report of Child Social Communication
Time frame: Between 25-30 weeks
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.
Caregiver Report of Child Disruptive Behavior
Time frame: Between 25-30 weeks
The caregiver's assessment of the child's disruptive behavior is measured from the Eyberg Child Behavior Inventory.
Family Life Impairment Scale
Time frame: Between 25-30 weeks
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Where
- Evanston, Illinois
Collaborators
University of Texas at Austin
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 29, 2026 · Source of record for eligibility and locations