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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the best way to use two different parent-led approaches to help young children with autism. It focuses on teaching parents to support their child's social skills and manage disruptive behaviors. Six different treatment paths begin with either social communication (Project ImPACT) or disruptive behavior training (RUBI Autism Network Parent Training) and then vary in frequency or incorporate new tools like video feedback. Families with children aged 18 to 48 months who have been identified with autism and speak English at home may find this trial suitable. Parents should be ready to learn strategies to improve their child's communication and behavior. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering families a chance to contribute to important early findings.

Will I have to stop taking my current medications?

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

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that both the Social Communication and Disruptive Behavior programs have been well-received by participants in past studies. Project ImPACT, the Social Communication program, helps parents enhance their children's social and communication skills. It has been used successfully with young children with autism, showing positive results without major safety issues.

Similarly, the Disruptive Behavior program, known as the RUBI Parent Training program, has been tested with children who have autism and challenging behaviors. Studies indicate that parents find it useful for managing behaviors like aggression and tantrums. These programs have been used without significant negative effects, suggesting they are safe.

This trial phase focuses mainly on understanding how well a treatment works and how different factors might influence the results. Although this phase does not specifically test safety, previous successful studies with these programs suggest they are considered safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these parental interventions for young children with autism because they offer a unique approach to managing disruptive behavior and enhancing social communication skills. Unlike traditional treatments that often involve direct therapy with the child, these methods actively involve parents as key participants, potentially increasing the effectiveness and sustainability of the interventions. The study explores different combinations, such as reducing the frequency of sessions or adding video feedback tools, which can help tailor the treatment to each child's needs and improve outcomes. This personalized and flexible strategy could lead to more effective ways to support children with autism and their families.

What evidence suggests that this trial's treatments could be effective for young children with autism?

Research has shown that Project ImPACT, one of the interventions in this trial, can improve children's social communication skills when parents assist their children with autism. Studies have found that when parents learn these techniques, their children's communication and play skills improve. Meanwhile, the RUBI Parent Training program, another intervention in this trial, has successfully reduced disruptive behavior in children with autism. This method outperforms basic parent education, leading to noticeable decreases in disruptive behavior and noncompliance. Both programs offer structured support for parents, aiming to enhance children's social skills and reduce challenging behaviors. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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) 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 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]

Citations

1. rubinetwork.org rubinetwork.org/store/

Store The RUBI Autism Network has developed and tested a structured parent training (PT) manual for children with ASD and disruptive behaviors.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9959946/

The RUBI Parent Training for Disruptive Behavior in a ... In randomized trials, RUBI-PT was found to be superior to parent education in reducing disruptive behavior and noncompliance, being acceptable ...

3. partnerstraining.org partnerstraining.org/wp-content/uploads/2017/02/Parent-Training-for-Disruptive-Behaviors-in-Autism-Spectrum-Disorder.pdf

Parent-Training-for-Disruptive-Behaviors-in-Autism- ... • Children with ASD + disruptive behavior and their parents/caregivers. • Living near one of 4 collaborating sites. • part of the Georgia Partnership for ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1750946721001367

Community-based parent-training for disruptive behaviors ... Overall, the studies yielded a standard mean difference (SMD) in disruptive behavior of −0.59 [95 % CI (−0.88, −0.30); p < 0.001] which indicates that compared ...

5. cebc4cw.org cebc4cw.org/program/rubi-parent-training/

CEBC » Program › Rubi Parent Training Parent training for disruptive behavior: The RUBI Autism Network [Clinician manual]. Programs that Work Series. Oxford University Press. Bearss, K., Johnson, C.

6. amazon.com amazon.com/Parent-Training-Disruptive-Behavior-Clinician/dp/0190627816

Parent Training for Disruptive Behavior: The RUBI Autism ... This Therapist Guide, Parent Training for Disruptive Behavior, is designed for therapists to use with parents of children with ASD and challenging behaviors.

7. academic.oup.com academic.oup.com/book/1248/chapter/140180523

Supplemental Sessions | Parent Training for Disruptive Behavior This type of token economy can be especially helpful to reduce recurrent disruptive behavior such as inappropriate screaming, hitting, or climbing on furniture.

8. abacnj.com abacnj.com/product/introduction-to-the-rubi-parent-training-program

Introduction to The RUBI Parent Training Program ... This course is perfect for those that want an in-depth look at the evidence base behind the RUBI Parent Training Program.