Ameliorate Childhood Obesity Risks From Newer Antipsychotics for Autism Spectrum Disorder
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Pittsburgh
- Enrollment
- 10
- Locations
- 2
- Primary Endpoint
- Inflammation as indicated by change in circulating high sensitivity C-reactive protein (hs-CRP)
Study Overview
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 (SGAs) has increased in children with Autism Spectrum Disorder (ASD) in the last decade. However, SGAs are associated with serious metabolic side effects in youth that include cardiovascular disease, hypertension, and diabetes mellitus. This makes the public health impact of treating medication-induced metabolic disturbances almost as important as treating the mental illness itself. Improving health and reducing premature mortality in people with severe mental illness, the investigators propose to provide early weight management prevention, delivered by clinicians, for youth starting SGAs in order to target common modifiable health risk factors in the developmental process. This study will provide an urgently needed practical model for integrating weight management into academic- and community-based autism care.
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 within standard psychiatric care setting in an empirically-validated intervention for weight management; (3) utilizing a collaborative care model for weight management in psychiatric care for youth starting second generation antipsychotics (SGAs) to prevent/decelerate metabolic dysfunction; and (4) identifying factors that affect implementation into all Autism Treatment Network (ATN) sites. Given recent calls to move toward community-based obesity prevention approaches among high-risk youth, this study will provide an urgently needed intervention for adolescents and young adults with ASD on medications known to have untoward metabolic adverse effects. Moreover, this study will serve as a pilot mechanism to expand upon the findings in multiple ATN sites in a large-scale randomized control trial while measuring cardiometabolic outcomes. This pilot investigation has the potential to change standard of care within clinical practice that can be widely disseminated.
Aim 1: To refine the HH4L manual to meet the needs of youth/adolescents and young adults (IQ > 70) with ASD on SGAs by adding Cognitive Behavioral Therapy (CBT) techniques for managing behaviors related to eating and physical activity to an empirically-validated pediatric obesity manual and incorporating developmentally appropriate modifications for individuals with ASD with an emphasis on family-based changes.
Hypothesis 1.1: The CBT intervention will be feasible to deliver to adolescents and young adults with ASD and their family members.
Hypothesis 1.2: Participants will attend treatment regularly with low attrition (≤ 20%) and high attendance (>80%).
Aim 2: To test the efficacy of a psychiatrically-embedded weight management program for youth with ASD on SGAs. At the end of the 6-month program, youth receiving the weight management program (HH4L) will show improvements in:
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 8 Years to 26 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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)
- •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 Criteria
- •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.
- •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).
Outcomes
Primary Outcomes
Inflammation as indicated by change in circulating high sensitivity C-reactive protein (hs-CRP)
Time Frame: Change from Baseline to intervention completion at 6 months
hs-CRP level from blood work completed at local lab
Change in Body Mass Index (BMI) z-score
Time Frame: Change from Baseline to intervention completion at 6 months
BMI z-scores will be calculated from participant height(cm), weight(kg), sex and age
Secondary Outcomes
- Change in Blood pressure(Change from Baseline to intervention completion at 6 months)
- Implementation effectiveness(Month 6)
- Change in Waist circumference(Change from Baseline to intervention completion at 6 months)
- Change in Insulin(change from Baseline to intervention completion at 6 months)
- Change in HOMA-IR(change from Baseline to intervention completion at 6 months)
- Change in aberrant behaviors(change from Baseline to intervention completion at 6 months)
- Change in weight loss behaviors(change from Baseline to intervention completion at 6 months)
- Change in emotional dysregulation(change from Baseline to intervention completion at 6 months)
- Change in Lipid Panel Lab Values(Change from Baseline to intervention completion at 6 months)
- Change in physical activity habits(change from Baseline to intervention completion at 6 months)
- Change in Glucose Serum(Change from Baseline to intervention completion at 6 months)
- Change in parenting stress(change from Baseline to intervention completion at 6 months)
Investigators
Dana Rofey
Associate Professor of Psychiatry and Pediatrics
University of Pittsburgh