Optimizing Outcomes for Young Autistic Children

Part of paid clinical trials in Evanston, Illinois.

Sponsor
Northwestern University
Study ID
NCT05926687
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Months - 48 Months
Healthy Volunteers
Accepted

Interventions

  • Social Communication — BEHAVIORAL
    Intervention: Social Communication Who: Parent \& Child \& Therapist Frequency: 1-hour twice/week
  • Disruptive Behavior — BEHAVIORAL
    Intervention: Disruptive Behavior Who: Parent \& Therapist only Frequency: 1-hour once/week
  • Social Communication + Reduce Frequency — BEHAVIORAL
    Intervention: Social Communication Who: Parent \& Child \& Therapist Frequency: 1-hour once/week
  • Social Communication + Add Tools — BEHAVIORAL
    Intervention: Social Communication Who: Parent \& Child \& Therapist Frequency: 1-hour twice/week
  • Disruptive Behavior + Reduce Frequency — BEHAVIORAL
    Intervention: Disruptive Behavior Who: Parent \& Therapist only Frequency: 1-hour every other week
  • Disruptive Behavior + Add Tools — BEHAVIORAL
    Intervention: Disruptive Behavior Who: Parent \& Therapist only Frequency: 1-hour once/week

Study Details

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.

Key Dates

Start date
Jul 11, 2023
Status verified
Jan 2026
Primary completion
Feb 28, 2027
Completion
Feb 28, 2027

Study Design

Enrollment
184 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

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

Primary Outcome Measure

Observed Child Social Communication [ Time Frame: Between 25-30 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Northwestern UniversityEvanstonIllinois60208
Megan Y Roberts, PhD
[email protected]
847-491-3183
Laura J Sudec, MSW
[email protected]
847-491-3183

Find similar trials in Evanston, IL

By condition
Autism spectrum disorder
By specialty
Pediatrics
By research site
Northwestern University· Evanston, IL

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