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

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ClinicalTrials.gov Identifier: NCT03131635
Recruitment Status : Recruiting
First Posted : April 27, 2017
Last Update Posted : September 1, 2017
Sponsor:
Information provided by (Responsible Party):

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.


Condition or disease Intervention/treatment
Autism Spectrum Disorder Autism Behavioral: Developmental Reciprocity Treatment Program (DRT-P)

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectiveness of a Developmental Reciprocity Treatment Program in Autism
Actual Study Start Date : July 26, 2017
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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)


Outcome Measures

Primary Outcome Measures :
  1. Change from Baseline on the Social Responsiveness Scale (SRS) at 6, 12, and 24 weeks [ Time Frame: Baseline, 6, 12, and 24 weeks ]

Secondary Outcome Measures :
  1. Change from Baseline on the Brief Observation of Social Communication Change (BOSCC) at 24 weeks [ Time Frame: Baseline and 24 weeks ]
  2. 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 ]

Other Outcome Measures:
  1. Change from Baseline on the Structured Lab Observation (SLO) at 6, 12, and 24 weeks [ Time Frame: Baseline, 6, 12, and 24 weeks ]
  2. Change from Baseline on the Mullen Scales of Early Learning at 24 weeks [ Time Frame: Baseline and 24 weeks ]
  3. Change from Baseline on the MacArthur-Bates Communication Development Inventory at 12, and 24 weeks [ Time Frame: Baseline, 12, and 24 weeks ]
  4. 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 ]
  5. Change from Baseline on the Clinical Global Impression Scale at 12, and 24 weeks [ Time Frame: Baseline, 12, and 24 weeks ]
  6. Change from Baseline on the Family Empowerment Scale (FES) at 12, and 24 weeks [ Time Frame: Baseline, 12, and 24 weeks ]
  7. 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 ]
  8. Change from Baseline on the Short Sensory Profile Questionnaire (SSPQ) at 12, and 24 weeks [ Time Frame: Baseline, 12, and 24 weeks ]
  9. Change from Baseline on the Parenting Stress Index (PSI) at 12, and 24 weeks [ Time Frame: Baseline, 12, and 24 weeks ]
  10. Change from Baseline on the Aberrant Behavior Checklist (ABC) at 12, and 24 weeks [ Time Frame: Baseline, 12, and 24 weeks ]
  11. Change from Baseline on the Repetitive Behavior Scale Revised (RBS-R) at 12, and 24 weeks [ Time Frame: Baseline, 12, and 24 weeks ]
  12. Change from Baseline on the Pediatric Quality of Life Scale at 12, and 24 weeks [ Time Frame: Baseline, 12, and 24 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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 of a developmentally based intervention;
  • Participants living more than 45 miles from Stanford University;
  • Children with more than 15 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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03131635


Contacts
Contact: Estefania Millan, MA (650) 736-1235 mmillan2@stanford.edu
Contact: Robin Libove, BS (650) 736-1235 rlibove@stanford.edu

Locations
United States, California
Stanford University Recruiting
Stanford, California, United States, 94305-5719
Contact: Estefania Millan, MA    650-736-1235    mmillan2@stanford.edu   
Contact: Robin Libove, BS    (650) 736-1235    rlibove@stanford.edu   
Principal Investigator: Antonio Y. Hardan, MD         
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Antonio Y. Hardan, MD Stanford University
More Information

Responsible Party: Antonio Hardan, Professor of Psychiatry and Behavioral Sciences, Stanford University
ClinicalTrials.gov Identifier: NCT03131635     History of Changes
Other Study ID Numbers: IRB 40026
First Posted: April 27, 2017    Key Record Dates
Last Update Posted: September 1, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Antonio Hardan, Stanford University:
Developmental

Additional relevant MeSH terms:
Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders