Parental Interventions for Young Children with Autism

Overseen By Megan Y Roberts, PhD

Age: < 18

Sex: Any

Trial Phase: Phase 2

Sponsor: Northwestern University

Disqualifiers: Other diagnosis, Disability, Vision impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

184 Participants Needed

Trial Summary

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}

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.

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.

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
• Social Communication

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

Disruptive Behavior is already approved in United States for the following indications:

Approved in United States as Parent Training for Disruptive Behavior for:

• Disruptive behaviors in children with Autism Spectrum Disorder (ASD)

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

University of Texas at Austin

Collaborator

Trials

387

Recruited

86,100+

Findings from Research

Parent-Child Interaction Therapy (PCIT) was found to be effective in reducing disruptive behaviors in children with autism spectrum disorder (ASD) and developmental delays (DD), based on a study involving 109 children with ASD and 2,324 without.

The study demonstrated that PCIT can lead to positive changes in the parent-child relationship, highlighting its potential as a viable intervention in community-based settings, even when delivered by non-specialized clinicians.

NCBI (Pubmed)

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. Quetsch, LB., Bradley, RS., Theodorou, L., et al.[2022]

A structured parent training program for 16 children aged 3-6 with autism spectrum disorders showed high acceptability, with an 84% attendance rate for core sessions and 14 out of 16 families completing the treatment.

The program demonstrated initial efficacy, as independent clinician ratings indicated significant improvement in 14 of 16 children, and parent-reported irritability decreased by 54% over the 6-month intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot study of parent training in young children with autism spectrum disorders and disruptive behavior. Bearss, K., Johnson, C., Handen, B., et al.[2021]

A pilot study involving three mother-child dyads showed that parents can effectively learn and implement intervention techniques for social communication and disruptive behavior in children with autism, indicating the feasibility of a sequenced approach to training.

However, the study found that while mothers initially learned the social communication strategies well, their ability to maintain these strategies declined when they began implementing positive behavior support techniques, suggesting a need for ongoing support to ensure adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parent-Implemented Positive Behavior Support Strategies for Young Children on the Autism Spectrum: A Pilot Investigation. Hampton, LH., Stern, YS., Fipp-Rosenfield, H., et al.[2023]

In a 6-month trial involving 180 children with autism spectrum disorder, parent training (PT) was found to be more effective than parent education programs (PEP) in reducing disruptive and noncompliant behaviors.

The severity of ADHD and anxiety were significant moderators of treatment outcomes, indicating that children with higher levels of these conditions may benefit differently from PT, while IQ and ASD severity did not affect the effectiveness of the intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Moderators of Parent Training for Disruptive Behaviors in Young Children with Autism Spectrum Disorder. Lecavalier, L., Smith, T., Johnson, C., et al.[2023]

An open feasibility trial of group-based RUBI parent training involved 18 children with autism spectrum disorder (ASD) and showed that 64.7% of participants were rated as much or very much improved after 24 weeks, indicating promising preliminary efficacy.

The high completion rate of 83% and strong therapist fidelity (98.8%) suggest that group interventions could be a viable and effective approach for delivering support to families of children with ASD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of Group Parent Training for Children with Autism Spectrum Disorder and Disruptive Behavior: A Demonstration Pilot. Burrell, TL., Postorino, V., Scahill, L., et al.[2021]

Parent-Child Interaction Therapy (PCIT) significantly reduced disruptive behaviors in children with autism spectrum disorder (ASD) aged 4-10 years, as shown in a randomized clinical trial with 55 participants.

The study found that PCIT improved parent-child communication and compliance while reducing parental stress, and these benefits were consistent regardless of the severity of ASD, language skills, or age.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parent-Child Interaction Therapy for Children with Disruptive Behaviors and Autism: A Randomized Clinical Trial. Allen, K., Harrington, J., Quetsch, LB., et al.[2023]

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]