Back to resultsEffectiveness of a Developmental Reciprocity Treatment Program in Autism (DRTP)
Primary Purpose
Autism Spectrum Disorder, Autism
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Developmental Reciprocity Treatment Program (DRT-P)
Sponsored by
About this trial
This is an interventional treatment trial for Autism Spectrum Disorder focused on measuring Developmental
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.
Sites / Locations
- Stanford University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Developmental Reciprocity Treatment Program (DRT-P)
Delayed Treatment Group (DTG)
Arm Description
Developmental Reciprocity Treatment is an early intervention that applies developmentally-informed teaching methods in naturalistic settings in order to target social and communication deficits.
Outcomes
Primary Outcome Measures
Change from Baseline on the Social Responsiveness Scale (SRS) at 6, 12, and 24 weeks
Change from Baseline on the Brief Observation of Social Communication Change (BOSCC) at 24 weeks
Secondary Outcome Measures
Change from Baseline on the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at 12, and 24 weeks
Change from Baseline on the Stanford Social Dimensions Scale (SSDS) Questionnaire.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03131635
Brief Title
Effectiveness of a Developmental Reciprocity Treatment Program in Autism
Acronym
DRTP
Official Title
Effectiveness of a Developmental Reciprocity Treatment Program in Autism
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Terminated
Why Stopped
Terminated (halted prematurely) due to COVID-19.
Study Start Date
July 26, 2017 (Actual)
Primary Completion Date
July 16, 2020 (Actual)
Study Completion Date
July 16, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder, Autism
Keywords
Developmental
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Developmental Reciprocity Treatment Program (DRT-P)
Arm Type
Experimental
Arm Description
Developmental Reciprocity Treatment is an early intervention that applies developmentally-informed teaching methods in naturalistic settings in order to target social and communication deficits.
Arm Title
Delayed Treatment Group (DTG)
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Developmental Reciprocity Treatment Program (DRT-P)
Intervention Description
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 Measure Information:
Title
Change from Baseline on the Social Responsiveness Scale (SRS) at 6, 12, and 24 weeks
Time Frame
Baseline, 6, 12, and 24 weeks
Title
Change from Baseline on the Brief Observation of Social Communication Change (BOSCC) at 24 weeks
Time Frame
Baseline and 24 weeks
Secondary Outcome Measure Information:
Title
Change from Baseline on the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at 12, and 24 weeks
Time Frame
Baseline, 12, and 24 weeks
Title
Change from Baseline on the Stanford Social Dimensions Scale (SSDS) Questionnaire.
Time Frame
Baseline, 12, and 24 weeks
Other Pre-specified Outcome Measures:
Title
Change from Baseline on the Structured Lab Observation (SLO) at 6, 12, and 24 weeks
Time Frame
Baseline, 6, 12, and 24 weeks
Title
Change from Baseline on the Mullen Scales of Early Learning at 24 weeks
Time Frame
Baseline and 24 weeks
Title
Change from Baseline on the MacArthur-Bates Communication Development Inventory at 12, and 24 weeks
Time Frame
Baseline, 12, and 24 weeks
Title
Change from Baseline on the Behavior Rating Inventory of Executive Function, Preschool (BRIEF-P) at 12, and 24 weeks
Time Frame
Baseline, 12, and 24 weeks
Title
Change from Baseline on the Clinical Global Impression Scale at 12, and 24 weeks
Time Frame
Baseline, 12, and 24 weeks
Title
Change from Baseline on the Family Empowerment Scale (FES) at 12, and 24 weeks
Time Frame
Baseline, 12, and 24 weeks
Title
Change from Baseline on the Social attention and word-learning eye tracking task at 12, and 24 weeks
Time Frame
Baseline, 12, and 24 weeks
Title
Change from Baseline on the Short Sensory Profile Questionnaire (SSPQ) at 12, and 24 weeks
Time Frame
Baseline, 12, and 24 weeks
Title
Change from Baseline on the Parenting Stress Index (PSI) at 12, and 24 weeks
Time Frame
Baseline, 12, and 24 weeks
Title
Change from Baseline on the Aberrant Behavior Checklist (ABC) at 12, and 24 weeks
Time Frame
Baseline, 12, and 24 weeks
Title
Change from Baseline on the Repetitive Behavior Scale Revised (RBS-R) at 12, and 24 weeks
Time Frame
Baseline, 12, and 24 weeks
Title
Change from Baseline on the Pediatric Quality of Life Scale at 12, and 24 weeks
Time Frame
Baseline, 12, and 24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonio Y. Hardan, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305-5719
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Effectiveness of a Developmental Reciprocity Treatment Program in Autism
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