Clinical trial NCT03131635: Effectiveness of a Developmental Reciprocity Treatment Program in Autism
Official title: Effectiveness of a Developmental Reciprocity Treatment Program in Autism
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Autism Spectrum Disorder
Autism
Keywords: Developmental
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2017-04-27
Enrollment: 54
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change from Baseline on the Social Responsiveness Scale (SRS) at 6, 12, and 24 weeks
timeFrame: Baseline, 6, 12, and 24 weeks
measure: Change from Baseline on the Brief Observation of Social Communication Change (BOSCC) at 24 weeks
timeFrame: Baseline and 24 weeks
Secondary outcomes:
measure: Change from Baseline on the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at 12, and 24 weeks
timeFrame: Baseline, 12, and 24 weeks
measure: Change from Baseline on the Stanford Social Dimensions Scale (SSDS) Questionnaire.
timeFrame: Baseline, 12, and 24 weeks
Other outcomes:
measure: Change from Baseline on the Structured Lab Observation (SLO) at 6, 12, and 24 weeks
timeFrame: Baseline, 6, 12, and 24 weeks
measure: Change from Baseline on the Mullen Scales of Early Learning at 24 weeks
timeFrame: Baseline and 24 weeks
measure: Change from Baseline on the MacArthur-Bates Communication Development Inventory at 12, and 24 weeks
timeFrame: Baseline, 12, and 24 weeks
measure: Change from Baseline on the Behavior Rating Inventory of Executive Function, Preschool (BRIEF-P) at 12, and 24 weeks
timeFrame: Baseline, 12, and 24 weeks
measure: Change from Baseline on the Clinical Global Impression Scale at 12, and 24 weeks
timeFrame: Baseline, 12, and 24 weeks
measure: Change from Baseline on the Family Empowerment Scale (FES) at 12, and 24 weeks
timeFrame: Baseline, 12, and 24 weeks
measure: Change from Baseline on the Social attention and word-learning eye tracking task at 12, and 24 weeks
timeFrame: Baseline, 12, and 24 weeks
measure: Change from Baseline on the Short Sensory Profile Questionnaire (SSPQ) at 12, and 24 weeks
timeFrame: Baseline, 12, and 24 weeks
measure: Change from Baseline on the Parenting Stress Index (PSI) at 12, and 24 weeks
timeFrame: Baseline, 12, and 24 weeks
measure: Change from Baseline on the Aberrant Behavior Checklist (ABC) at 12, and 24 weeks
timeFrame: Baseline, 12, and 24 weeks
measure: Change from Baseline on the Repetitive Behavior Scale Revised (RBS-R) at 12, and 24 weeks
timeFrame: Baseline, 12, and 24 weeks
measure: Change from Baseline on the Pediatric Quality of Life Scale at 12, and 24 weeks
timeFrame: Baseline, 12, and 24 weeks
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Antonio Y. Hardan, MD
role: PRINCIPAL_INVESTIGATOR
References: