What is the mechanism of action of this treatment?

Parent-mediated interventions for Autism Spectrum Disorder (ASD) involve training parents to implement evidence-based strategies to enhance their child's social communication and behavioral skills. These strategies include modeling appropriate behaviors, using reinforcement to encourage desired actions, and engaging in structured play activities. The primary mechanism of action is the consistent and intensive support provided by parents in the child's natural environment, which can lead to more significant and sustained developmental improvements. This approach is particularly important for ASD patients as it utilizes the child's existing support system, making the intervention more accessible and potentially more effective over time.

What side effects are associated with this type of intervention?

Parent-mediated interventions for Autism Spectrum Disorder (ASD), such as those being studied in the trial, generally focus on behavioral and educational strategies rather than pharmacological treatments. These interventions are designed to improve communication, social skills, and reduce challenging behaviors through parent training. Known side effects are minimal and primarily involve the time and effort required from parents to learn and consistently apply the strategies. In contrast, pharmacological treatments for ASD, which are not the focus of the trial, can have side effects such as drowsiness, weight gain, and gastrointestinal issues. Overall, parent-mediated interventions are considered safe and effective with few adverse effects.

What prior FDA approvals exist?

The FDA has approved risperidone and aripiprazole for the treatment of irritability in children with Autism Spectrum Disorder (ASD). These medications help manage symptoms such as aggression, self-injury, and severe tantrums. Additionally, early intervention strategies, particularly parent-mediated interventions, are crucial for improving outcomes in children with ASD. These strategies involve training early intervention (EI) providers to deliver evidence-based techniques to parents, enabling them to support their child's development effectively.

What other types of research exist?

Promising novel alternatives to Parent-Mediated Intervention for ASD include: 1) Tele-therapy, which allows for remote delivery of interventions and has shown potential in recent studies. 2) Complementary and alternative therapies such as medical cannabis and cannabidiol, which have been explored for symptom management. 3) Early Intensive Behavioral Intervention (EIBI) with enhanced parental support tools like the EIBI Parental Self-Efficacy Scale. 4) Parent coaching programs based on models like the Early Start Denver Model, which provide structured support and training for parents.

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Behavioral Intervention

Reciprocal Imitation Training for Autism

N/A

Recruiting

Led By Wendy L Stone, PhD

Research Sponsored by University of Washington

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

The child has a diagnosis of ASD or displays social communication impairments

Be younger than 18 years old

Must not have

The parent or child has previously received RIT or coaching in another NDBI

The child has visual, hearing, or motor conditions that would compromise his/her ability to participate in RIT or assessments

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline to 9 months

Awards & highlights

No Placebo-Only Group

Summary

This study is evaluating whether a parent-mediated intervention can improve outcomes for children with autism.

Who is the study for?

This trial is for children with Autism Spectrum Disorder (ASD) or social communication impairments who attend weekly sessions with a provider. Parents or guardians must be over 18, speak English or Spanish, and have not received Reciprocal Imitation Training (RIT) before. Children with visual, hearing, or motor conditions that affect RIT participation are excluded.

What is being tested?

The study aims to improve early intervention services for children with ASD by training providers in the Part C Early Intervention system to use an evidence-based parent-mediated approach called Reciprocal Imitation Training (RIT).

What are the potential side effects?

Since this trial involves educational and behavioral interventions rather than medical treatments, traditional side effects are not applicable. However, there may be varying responses to the training from both children and parents.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My child has been diagnosed with autism or has trouble communicating socially.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My child or I have had therapy or coaching in a developmental intervention before.

Select...

My child has conditions affecting sight, hearing, or movement that may limit participation in the therapy or assessments.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline to 9 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline to 9 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline to 9 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Adapted Motor Imitation Scale (MIS)

Initiation of Joint Attention

Parenting Efficacy Scale (PES)

+4 more

Secondary study objectives

Family Life Impairment Scale (FLIS)

Language Environment Analysis (LENA) Vocal Complexity

Language Environment Analysis (LENA) Vocal Contingency

+2 more

Other study objectives

Developmental Play Assessment (DPA

Parenting Stress Index-Short Form

Vineland-3

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: RIT Training GroupExperimental Treatment1 Intervention

Providers in the RIT group (n=80) will receive intensive training (online tutorial, 2-day workshop, and virtual coaching and feedback in the field) in RIT and parent coaching and will be required to achieve fidelity prior to enrolling families from their caseload. They will then be asked to use the intervention with enrolled families for a minimum of 3 months. One intervention session per month for each enrolled family will be videotaped and scored for fidelity. Providers will receive monthly consultation from RIT trainers while these families are in the active treatment phase.

Group II: Treatment as UsualActive Control1 Intervention

Providers in the TAU group (n=80) will have three sessions videotaped and scored for each enrolled family to assess treatment differentiation. To incentivize agency participation, RIT training will be provided to the TAU group and other providers when data collection is complete.

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Parent-mediated interventions for Autism Spectrum Disorder (ASD) involve training parents to implement evidence-based strategies to enhance their child's social communication and behavioral skills. These strategies include modeling appropriate behaviors, using reinforcement to encourage desired actions, and engaging in structured play activities. The primary mechanism of action is the consistent and intensive support provided by parents in the child's natural environment, which can lead to more significant and sustained developmental improvements. This approach is particularly important for ASD patients as it utilizes the child's existing support system, making the intervention more accessible and potentially more effective over time.

Research-Based Intervention (RBI) for Autism Spectrum Disorder: Looking beyond Traditional Models and Outcome Measures for Clinical Trials.What are we targeting when we treat autism spectrum disorder? A systematic review of 406 clinical trials.Parent-mediated early intervention for young children with autism spectrum disorders (ASD).