Parental Interventions for Young Children with Autism

Recruiting in Palo Alto (17 mi)

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Northwestern University

Disqualifiers: Other diagnosis, Disability, Vision impairment, others

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What data supports the effectiveness of the treatment Parental Interventions for Young Children with Autism?

Research shows that parent training programs, like the ones used in the study, can significantly reduce disruptive behaviors in children with autism. For example, a study found that a structured parent training program led to a 54% decrease in disruptive behavior, and another study showed that Parent-Child Interaction Therapy (PCIT) improved parent-child relationships and reduced disruptive behaviors in children with autism. ^{1 2 3 4 5}

Is parent training for children with autism safe?

The studies on parent training programs for children with autism and disruptive behaviors show that these interventions are generally well-received by parents, with high completion rates and positive feedback, indicating they are safe for use. ^{1 2 4 5 6}

How is the treatment 'Parental Interventions for Young Children with Autism' different from other treatments for autism?

This treatment is unique because it involves training parents to manage disruptive behaviors and improve social communication in children with autism, using a structured program that can be delivered in a group format. This approach helps address the shortage of specialized services and empowers parents to implement strategies in daily routines, potentially increasing adherence and effectiveness. ^{1 2 3 5 6}

Research Team

Eligibility Criteria

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.

Inclusion Criteria

Child has normal vision

I want help to support my child's social skills and behavior control.

My child is exposed to English more than half of the time.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

First-stage Intervention

Participants receive either the Social Communication or Disruptive Behavior intervention for 12 weeks

12 weeks

1-hour sessions twice/week for Social Communication or once/week for Disruptive Behavior

Second-stage Intervention

Participants are re-randomized to continue, switch, or augment their intervention based on fidelity of implementation

12 weeks

Varies based on intervention and strategy (e.g., reduced frequency, added tools)

Follow-up

Participants are monitored for outcomes such as social communication, disruptive behavior, and family life participation

4-6 weeks

Treatment Details

Interventions

• Disruptive Behavior (Behavioural Intervention)
• Social Communication (Behavioural Intervention)

Trial Overview 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.

Participant Groups

Group I: Social Communication + Reduce Frequency Active Control 2 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 Tools Active Control 2 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 Behavior Active Control 2 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 Frequency Active Control 2 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 Tools Active Control 2 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 Communication Active Control 2 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

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

Dr. Jeffrey Sherman

Northwestern University

Chief Medical Officer

MD from Northwestern University

Dr. Alicia Löffler

Northwestern University

Chief Executive Officer since 2010

PhD from the University of Massachusetts at Amherst, post-doctoral training at Caltech

University of Texas at Austin

Collaborator

Trials

387

Recruited

86,100+

Dr. Elly Barry

University of Texas at Austin

Chief Medical Officer

MD from Harvard Medical School

Dr. Brian Windsor

University of Texas at Austin

Chief Executive Officer since 2023

PhD in Molecular Biology from the University of Texas at Austin

References

1. United States pubmed.ncbi.nlm.nih.gov

Community-based Agency Delivery of Parent-Child Interaction Therapy: Comparing Outcomes for Children with and Without Autism Spectrum Disorder and/or Developmental Delays. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

A pilot study of parent training in young children with autism spectrum disorders and disruptive behavior. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Parent-Implemented Positive Behavior Support Strategies for Young Children on the Autism Spectrum: A Pilot Investigation. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Moderators of Parent Training for Disruptive Behaviors in Young Children with Autism Spectrum Disorder. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Feasibility of Group Parent Training for Children with Autism Spectrum Disorder and Disruptive Behavior: A Demonstration Pilot. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Parent-Child Interaction Therapy for Children with Disruptive Behaviors and Autism: A Randomized Clinical Trial. [2023]