Effectiveness of a Developmental Reciprocity Treatment Program in Autism (DRTP)

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.

Study Overview

• Status: Terminated
• Conditions: Autism Spectrum Disorder; Autism
• Intervention / Treatment: Behavioral: Developmental Reciprocity Treatment Program (DRT-P)

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305-5719
      • Stanford University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 5 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Behavioral: 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.
NO_INTERVENTION: Delayed Treatment Group (DTG)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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
Change from Baseline on the Behavior Rating Inventory of Executive Function, Preschool (BRIEF-P) at 12, and 24 weeks	Baseline, 12, and 24 weeks
Change from Baseline on the Clinical Global Impression Scale at 12, and 24 weeks	Baseline, 12, and 24 weeks
Change from Baseline on the Family Empowerment Scale (FES) at 12, and 24 weeks	Baseline, 12, and 24 weeks
Change from Baseline on the Social attention and word-learning eye tracking task at 12, and 24 weeks	Baseline, 12, and 24 weeks
Change from Baseline on the Short Sensory Profile Questionnaire (SSPQ) at 12, and 24 weeks	Baseline, 12, and 24 weeks
Change from Baseline on the Parenting Stress Index (PSI) at 12, and 24 weeks	Baseline, 12, and 24 weeks
Change from Baseline on the Aberrant Behavior Checklist (ABC) at 12, and 24 weeks	Baseline, 12, and 24 weeks
Change from Baseline on the Repetitive Behavior Scale Revised (RBS-R) at 12, and 24 weeks	Baseline, 12, and 24 weeks
Change from Baseline on the Pediatric Quality of Life Scale at 12, and 24 weeks	Baseline, 12, and 24 weeks

Collaborators and Investigators

• Sponsor: Stanford University

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 26, 2017
• Primary Completion (ACTUAL): July 16, 2020
• Study Completion (ACTUAL): July 16, 2020

Study Registration Dates

• First Submitted: April 24, 2017
• First Submitted That Met QC Criteria: April 24, 2017
• First Posted (ACTUAL): April 27, 2017

Study Record Updates

• Last Update Posted (ACTUAL): September 15, 2022
• Last Update Submitted That Met QC Criteria: September 11, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Developmental
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autistic Disorder; Autism Spectrum Disorder
• Other Study ID Numbers: IRB 40026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No