Status:
COMPLETED
Weight Management Intervention for Youth and Young Adults With Autism Spectrum Disorder
Lead Sponsor:
University of Pittsburgh
Collaborating Sponsors:
Massachusetts General Hospital
Conditions:
Autism Spectrum Disorder
Eligibility:
All Genders
8-26 years
Phase:
NA
Brief Summary
Psychotropic medications are the first-line treatment across several diagnostic categories encompassing severe mood disturbances and behavioral problems. The use of Second Generation Antipsychotics (S...
Detailed Description
The innovations are four-fold: (1) adapting an evidence-based weight management treatment for youth/adolescents and young adults with Autism Spectrum Disorder (ASD); (2) training providers embedded wi...
Eligibility Criteria
Inclusion
- Diagnosis of Autism Spectrum Disorder based on Autism Diagnostic Observation Schedule, Second Edition (ADOS-2) and The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria.
- Clinically stable on current SGA treatment regimen with olanzapine, quetiapine, risperidone, aripiprazole, ziprasidone, or clozapine.
- The patient meets one of the following criteria:
- If the participant is under 20 years old, the participant either:
- has a BMI greater than or equal to 85th percentile, corrected for age and sex, AND has a documented 3% increase or greater in BMI within the last 12 months, while on SGAs, or
- has persistent and unrelenting BMI percentile at or above 98%, corrected for age and sex (3% change in BMI is not necessary).
- If the participant is 20 years old or older, the participant either:
- has a BMI greater than or equal to 30 AND has a documented 3% increase or greater in BMI within the last 12 months, while on SGAs, or
- has persistent and unrelenting BMI at or above 40 (3% change in BMI is not necessary)4. Involvement of at least one parent or guardian if ≤ 18 years of age. If \> 18, an adult caregiver living with the participant must agree to complete the parent/guardian measures.
- Age between 8 and 26, inclusive.
- Prior to the study, minor participants must provide assent to participate in the study, and their parents (guardians) must provide written informed consent. Individuals \> 18 will provide written consent.
Exclusion
- IQ \< 70.
- Recent suicide attempt (within 1 month of study entry) or illness severity requiring acute psychiatric hospitalization within 30 days of study entry.
- Current weight management treatment with CBT by an appropriately trained provider using a manual. If currently receiving treatment, willingness to suspend treatment for 12-week acute treatment phase of study.
- New mood stabilizer, selective serotonin reuptake inhibitor (SRRI) or stimulant medication. If patient has been stable on psychotropic medication for 30 days, inclusion is permitted.
- Pregnant.
- Diagnosis of diabetes.
- Participant and/or parent/caregiver/service provider/partner/friend of the participant unwilling or not able to commute for study visits
- Unwilling to have bloodwork.
- Taking medications that affect bodyweight, other than SGAs, for less than a month (e.g., Metformin, Prednisone, Topiramate, or any other medications, in the opinion of the Site Principal Investigator, would deem as a medication that would affect bodyweight).
Key Trial Info
Start Date :
August 7 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2021
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03865719
Start Date
August 7 2019
End Date
December 1 2021
Last Update
April 6 2022
Active Locations (1)
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1
Autism Treatment Network Site at Merck Child and Adolescent Outpatient Clinic
Pittsburgh, Pennsylvania, United States, 15203