Recruiting
Phase 2

Project ImPACT & Parent Training

Sponsor:

Northwestern University

Code:

NCT05926687

Conditions

Autism

Autism Spectrum Disorder

Eligibility Criteria

Sex: All

Age: 1 - 4

Healthy Volunteers: Accepted

Interventions

Social Communication

Disruptive Behavior

Social Communication + Reduce Frequency

Social Communication + Add Tools

Disruptive Behavior + Reduce Frequency

Study Details

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.

Conditions

Autism

Autism Spectrum Disorder

Study ID

NCT05926687

Start date

Jul 11, 2023

Status verified date

Jan, 2026

Completion date

Feb 28, 2027

Anticipated

Primary completion date

Feb 28, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 1 - 4

Healthy Volunteers: Accepted

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

Study Design

Enrollment

184 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Social Communication + Reduce Frequency

Starting 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

active comparator: Social Communication + Add Tools

Starting 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

active comparator: Social Communication + Switch Intervention to Disruptive Behavior

Starting 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

active comparator: Disruptive Behavior + Reduce Frequency

Starting 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

active comparator: Disruptive Behavior + Add Tools

Starting 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

active comparator: Disruptive Behavior + Switch Intervention to Social Communication

Starting 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

Social Communication

Intervention: Social Communication Who: Parent \& Child \& Therapist Frequency: 1-hour twice/week

Disruptive Behavior

Intervention: Disruptive Behavior Who: Parent \& Therapist only Frequency: 1-hour once/week

Social Communication + Reduce Frequency

Intervention: Social Communication Who: Parent \& Child \& Therapist Frequency: 1-hour once/week

Social Communication + Add Tools

Intervention: Social Communication Who: Parent \& Child \& Therapist Frequency: 1-hour twice/week

Disruptive Behavior + Reduce Frequency

Intervention: Disruptive Behavior Who: Parent \& Therapist only Frequency: 1-hour every other week

Disruptive Behavior + Add Tools

Intervention: Disruptive Behavior Who: Parent \& Therapist only Frequency: 1-hour once/week

Primary outcome measure

  • Observed Child Social Communication [ Time Frame: Between 25-30 weeks ]
  • Observed Child Disruptive Behavior [ Time Frame: Between 25-30 weeks ]
  • Caregiver Report of Child Social Communication [ Time Frame: Between 25-30 weeks ]
  • Caregiver Report of Child Disruptive Behavior [ Time Frame: Between 25-30 weeks ]
  • Family Life Impairment Scale [ Time Frame: Between 25-30 weeks ]

Central Contacts and Locations

Central contacts

Laura J Sudec, MSW

8474913183Laura.Sudec@northwestern.edu

Megan Y Roberts, PhD

8474913183megan.y.roberts@northwestern.edu

Locations

Northwestern University

Recruiting

Evanston, Illinois, United States, 60208

Contacts

Megan Y Roberts, PhD

847-491-3183megan.y.roberts@northwestern.edu

Laura J Sudec, MSW

847-491-3183laura.sudec@northwestern.edu

More Information

Sponsor

Northwestern University

Last update posted

Jan 29, 2026

Last verified

Jan, 2026

Keywords

  • intervention
  • early intervention
  • toddlers
  • autistic
  • autism
  • virtual
  • tele-health

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Northwestern University on 2026-01-29.