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Behavioural Intervention

Parental Interventions for Young Children with Autism

Phase 2
Recruiting
Research Sponsored by Northwestern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up between 25-30 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial will study how best to sequence two interventions for parents, to improve communication and reduce disruptive behavior. #Study

Who is the study for?
This trial is for young children aged 18 to 48 months who are on the autism spectrum, as indicated by specific research criteria. They should not have other diagnoses or disabilities, must have normal vision, and be exposed to English at least half of the time. A caregiver must be willing and able to learn intervention strategies and understand conversational English.
What is being tested?
The study aims to find the best order for two parent-led interventions: one that improves social communication (Project ImPACT) and another that addresses disruptive behavior (Parent Training). It will also look into factors influencing how well these treatments work.
What are the potential side effects?
Since this trial involves behavioral interventions rather than medication, traditional side effects are not expected. However, there may be variations in individual responses to therapy sessions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~between 25-30 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and between 25-30 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Caregiver Report of Child Disruptive Behavior
Caregiver Report of Child Social Communication
Family Life Impairment Scale
+2 more
Secondary study objectives
Caregiver Perceived Stress
Caregiver Satisfaction

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

6Treatment groups
Active Control
Group I: Social Communication + Reduce FrequencyActive Control2 Interventions
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
Group II: Social Communication + Add ToolsActive Control2 Interventions
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
Group III: Social Communication + Switch Intervention to Disruptive BehaviorActive Control2 Interventions
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
Group IV: Disruptive Behavior + Reduce FrequencyActive Control2 Interventions
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
Group V: Disruptive Behavior + Add ToolsActive Control2 Interventions
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
Group VI: Disruptive Behavior + Switch Intervention to Social CommunicationActive Control2 Interventions
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

Find a Location

Who is running the clinical trial?

Northwestern UniversityLead Sponsor
1,646 Previous Clinical Trials
958,388 Total Patients Enrolled
3 Trials studying Autism Spectrum Disorder
207 Patients Enrolled for Autism Spectrum Disorder
University of Texas at AustinOTHER
375 Previous Clinical Trials
86,111 Total Patients Enrolled
4 Trials studying Autism Spectrum Disorder
611 Patients Enrolled for Autism Spectrum Disorder

Media Library

Disruptive Behavior (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05926687 — Phase 2
Autism Spectrum Disorder Research Study Groups: Social Communication + Reduce Frequency, Social Communication + Add Tools, Social Communication + Switch Intervention to Disruptive Behavior, Disruptive Behavior + Reduce Frequency, Disruptive Behavior + Add Tools, Disruptive Behavior + Switch Intervention to Social Communication
Autism Spectrum Disorder Clinical Trial 2023: Disruptive Behavior Highlights & Side Effects. Trial Name: NCT05926687 — Phase 2
Disruptive Behavior (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05926687 — Phase 2
~116 spots leftby Feb 2027
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