Effectiveness of a Developmental Reciprocity Treatment Program in Autism

Not Applicable

Terminated

• Conditions: Autism Spectrum Disorder; Autism
• Interventions: Behavioral: Developmental Reciprocity Treatment Program (DRT-P)

• Registration Number: NCT03131635
• Lead Sponsor: Stanford University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-04-24
• Study First Submitted QC: 2017-04-24
• Study First Posted: 2017-04-27
• Study Start: 2017-07-26
• Primary Completion: 2020-07-16
• Study Completion: 2020-07-16
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-11
• Last Update Posted: 2022-09-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 54

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 clinical opinion;
• 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 standard scores can be obtained;
• Stable treatment (e.g., applied behavior analysis), speech therapy, psychotropic medication(s) or biomedical intervention(s) for at least 1 month prior to baseline measurements with no anticipated changes during study participation;
• Availability of at least one English-speaking parent who can consistently participate in parent training and research measures;
• Clinical Global Impression(CGI) Severity Social Interaction and Communication Integrated Subscale ≥4;
• Meet the cutoff for Autism on the ADOS-2.

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 during session 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 the criteria above are met.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Developmental Reciprocity Treatment Program (DRT-P)	Developmental Reciprocity Treatment Program (DRT-P)	Developmental Reciprocity Treatment is an early intervention that applies developmentally-informed teaching methods in naturalistic settings in order to target social and communication deficits.

Primary Outcome Measures

Name	Time	Method
Change from Baseline on the Social Responsiveness Scale (SRS) at 6, 12, and 24 weeks	Baseline, 6, 12, and 24 weeks
Change from Baseline on the Brief Observation of Social Communication Change (BOSCC) at 24 weeks	Baseline and 24 weeks

Secondary Outcome Measures

Name	Time	Method
Change from Baseline on the Stanford Social Dimensions Scale (SSDS) Questionnaire.	Baseline, 12, and 24 weeks
Change from Baseline on the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at 12, and 24 weeks	Baseline, 12, and 24 weeks

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Stanford, California, United States