Effectiveness of a Developmental Reciprocity Treatment Program in Autism

NCT03131635 | Terminated

• 1 other identifier: IRB 40026
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorder; Autism

Keywords

Developmental

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Change from Baseline on the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at 12, and 24 weeks

  Baseline, 12, and 24 weeks

• Change from Baseline on the Stanford Social Dimensions Scale (SSDS) Questionnaire.

  Baseline, 12, and 24 weeks

Other Outcomes (12)

• Change from Baseline on the Structured Lab Observation (SLO) at 6, 12, and 24 weeks

  Baseline, 6, 12, and 24 weeks

• Change from Baseline on the Mullen Scales of Early Learning at 24 weeks

  Baseline and 24 weeks

• Change from Baseline on the MacArthur-Bates Communication Development Inventory at 12, and 24 weeks

  Baseline, 12, and 24 weeks

Study Arms (2)

Developmental Reciprocity Treatment Program (DRT-P)

EXPERIMENTAL

Developmental Reciprocity Treatment is an early intervention that applies developmentally-informed teaching methods in naturalistic settings in order to target social and communication deficits.

Behavioral: Developmental Reciprocity Treatment Program (DRT-P)

Delayed Treatment Group (DTG)

NO INTERVENTION

Interventions

Developmental Reciprocity Treatment Program (DRT-P) BEHAVIORAL

Developmental Reciprocity Treatment is an early intervention that applies developmentally-informed teaching methods in naturalistic settings in order to target social and communication deficits.

Developmental Reciprocity Treatment Program (DRT-P)

Eligibility Criteria

• Age: 2 Years - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Stanford, California, 94305-5719, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder; Autistic Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Antonio Y. Hardan, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry and Behavioral Sciences

Study Record Dates

• First Submitted: April 24, 2017
• First Posted: April 27, 2017
• Study Start: July 26, 2017
• Primary Completion: July 16, 2020
• Study Completion: July 16, 2020
• Last Updated: September 15, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)