Effectiveness of a Developmental Reciprocity Treatment Program in Autism

NCT ID: NCT03131635

Last Updated: 2022-09-15

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-26
• Study Completion Date: 2020-07-16

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Developmental Reciprocity Treatment Program (DRT-P)

Intervention Type: 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.

Delayed Treatment Group (DTG)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Antonio Hardan

Professor of Psychiatry and Behavioral Sciences

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Antonio Y. Hardan, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University

Stanford, California, United States

Countries

United States

Other Identifiers

IRB 40026

Identifier Type: -

Identifier Source: org_study_id