Effectiveness of a Developmental Reciprocity Treatment Program in Autism

Last updated: September 11, 2022
Sponsor: Stanford University
Overall Status: Terminated

Phase

N/A

Condition

Autism

Asperger's Disorder

Williams Syndrome

Treatment

N/A

Clinical Study ID

NCT03131635
IRB 40026
  • Ages 2-5
  • All Genders

Study Summary

This is a research study examining the effectiveness of a Developmental Reciprocity Treatment Program (DRT-P) in treating social deficits in children with Autism Spectrum Disorders (ASD). Developmental Reciprocity Treatment is an early intervention that applies developmentally-informed teaching methods in naturalistic settings in order to target social and communication deficits.

Researchers have begun to develop strategies to investigate the effectiveness of combining a parent training program teaching parents how to implement DRP with in-home, therapist-implemented treatment. To determine the effectiveness of the DRT-P, it will be compared to a delayed treatment group (DTG) by conducting a randomized controlled 24-week trial. This research will allow us to help in the development of therapeutic approaches that can meet the increasing service demands for families. We hope that investigating interventions that aim to improve core deficits will aid in providing better care for children with autism.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosis of Autism Spectrum Disorder based on Autism Diagnostic Interview Revised (ADI-R), Autism Diagnostic Observation Schedule (ADOS-2), DSM-5, and expert clinicalopinion;
  • Males and females in good medical health between 2.0 and 5 years 11 months;
  • Ability to participate in the testing procedures to the extent that valid standardscores can be obtained;
  • Stable treatment (e.g., applied behavior analysis), speech therapy, psychotropicmedication(s) or biomedical intervention(s) for at least 1 month prior to baselinemeasurements with no anticipated changes during study participation;
  • Availability of at least one English-speaking parent who can consistently participatein parent training and research measures;
  • Clinical Global Impression(CGI) Severity Social Interaction and CommunicationIntegrated Subscale ≥4;
  • Meet the cutoff for Autism on the ADOS-2.

Exclusion

Exclusion Criteria:

  • Current or lifetime diagnosis of severe psychiatric disorder (e.g., bipolar disorder,etc.);
  • A well-established genetic syndrome, such as Fragile X;
  • Presence of active medical problem (e.g., unstable seizure disorder or heart disease);
  • Child's primary language other than English;
  • Previous adequate trial or training of a developmentally based intervention;
  • Participants living more than 45 miles from Stanford University;
  • Children with more than 20 hours of in-home ABA;
  • At least one room of the house must be available to be dedicated to treatment duringsession times;
  • There must be no serious health and safety risks present in the home environment;
  • The research team has the right to refuse to perform sessions in-home even if thecriteria above are met.

Study Design

Total Participants: 54
Study Start date:
July 26, 2017
Estimated Completion Date:
July 16, 2020

Connect with a study center

  • Stanford University

    Stanford, California 94305-5719
    United States

    Site Not Available

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