Autism Spectrum Disorder Clinical Trial
— ACORN-ASDOfficial title:
Ameliorate Childhood Obesity Risks From Newer Antipsychotics for Autism Spectrum Disorder
Verified date | April 2022 |
Source | University of Pittsburgh |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 10 |
Est. completion date | December 1, 2021 |
Est. primary completion date | March 15, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 8 Years to 26 Years |
Eligibility | Inclusion Criteria: 1. 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. 2. Clinically stable on current SGA treatment regimen with olanzapine, quetiapine, risperidone, aripiprazole, ziprasidone, or clozapine. 3. The patient meets one of the following criteria: If the participant is under 20 years old, the participant either: 1. 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 2. 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: 1. 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 2. 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. 4. Age between 8 and 26, inclusive. 5. 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: 1. IQ < 70. 2. Recent suicide attempt (within 1 month of study entry) or illness severity requiring acute psychiatric hospitalization within 30 days of study entry. 3. 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. 4. 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. 5. Pregnant. 6. Diagnosis of diabetes. 7. Participant and/or parent/caregiver/service provider/partner/friend of the participant unwilling or not able to commute for study visits 8. Unwilling to have bloodwork. 9. 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). |
Country | Name | City | State |
---|---|---|---|
United States | Autism Treatment Network Site at Merck Child and Adolescent Outpatient Clinic | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
University of Pittsburgh | Massachusetts General Hospital |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Body Mass Index (BMI) z-score | BMI z-scores will be calculated from participant height(cm), weight(kg), sex and age | Change from Baseline to intervention completion at 6 months | |
Primary | Inflammation as indicated by change in circulating high sensitivity C-reactive protein (hs-CRP) | hs-CRP level from blood work completed at local lab | Change from Baseline to intervention completion at 6 months | |
Secondary | Implementation effectiveness | Parent/Caregiver and Research team completed questionnaire regarding project implementation. There are 12 items to be rated on Likert scales as well as 3 open-ended questions. There are no scales associated with this survey. The results will help us draw a qualitative picture of the parent satisfaction with the program and research team appraisal of the effectiveness of the program across subjects. | Month 6 | |
Secondary | Change in Waist circumference | Waist circumference measured in centimeters by dietician will be measured in duplicate, midway between the lowest rib and the superior border of the iliac crest, with a flexible tape. | Change from Baseline to intervention completion at 6 months | |
Secondary | Change in Blood pressure | Blood pressure measured in millimeters of mercury (mmHg) by dietician using a portable blood pressure cuff at intervention appointment | Change from Baseline to intervention completion at 6 months | |
Secondary | Change in Lipid Panel Lab Values | Fasting Lipids Panel from blood work completed at local lab (in mg/dL): Cholesterol, HDL, Cholesterol/HDL Ratio (calculated), LDL, Triglycerides | Change from Baseline to intervention completion at 6 months | |
Secondary | Change in Glucose Serum | Glucose serum level from blood work completed at local lab, mg/dL | Change from Baseline to intervention completion at 6 months | |
Secondary | Change in Insulin | Insulin level from blood work completed at local lab, µIU/mL | change from Baseline to intervention completion at 6 months | |
Secondary | Change in HOMA-IR | HOMA-IR is a method used to quantify insulin resistance (fasting glucose X fasting insulin / 22.5). | change from Baseline to intervention completion at 6 months | |
Secondary | Change in aberrant behaviors | Change in aberrant behaviors as measured by the Aberrant Behavior Checklist (ABC). The ABC is comprised of 58 items aimed to capture specific behavioral symptom areas: Irritability (15 items), Lethargy (16 items), Sterotypy (7 items), Hyperactive/Noncompliace (16 items)/Inappropriate Speech (4 items). To score the ABC, the individual items for each subscale are simply summed to their respective subtotals with higher scores reflective of more pervasive symptoms on that subscale. |
change from Baseline to intervention completion at 6 months | |
Secondary | Change in emotional dysregulation | Change in emotional dysregulation as measured by the Emotion Dysregulation Inventory with 30 items on two factors: (1) Reactivity, characterized by intense, rapidly escalating, sustained, and poorly modulated negative emotional reactions, and (2) Dysphoria, characterized by anhedonia, sadness, and nervousness. Items are rated on the following scale to reflect current behavior: and how much of a problem it has this been in the preceding 7 days?: Not at all (0, never happens) Mild (1, Present occasionally) and/or does not cause too much of a problem Moderate (2, Happens less than half the time and/or causes some problems Severe (3, Happens at least half of the time and/or substantially interferes Very Severe: 4, Almost always happens and/or causes a serious problems Scores for items on each factor are summed for a total scale score. Higher scores suggest more emotional dysregulation on that specific factor. |
change from Baseline to intervention completion at 6 months | |
Secondary | Change in parenting stress | Change in participant's parent's/caregiver's stress as measured by the Parenting Stress Short Form (PSI-SF), a 36 items assessing Total Stress is calculated by summing the raw score from three scales: Parental Distress, Parent-Child Dysfunctional Interaction, and Difficult Child. A higher score represents higher parent stress. | change from Baseline to intervention completion at 6 months | |
Secondary | Change in weight loss behaviors | Change in weight loss behaviors as measured by the Weight Loss Behavior Stage of Change Scale (WLB_SOC). The numerical values on the WLB-SOC questionnaire directly correspond to the five Stages of Change:1 = pre-contemplation; 2 = contemplation; 3 = preparation; 4 = action; 5 = maintenance The questionnaire has 5 sections: Potions, Dietary Fat, Fruits, Vegetables, Usual Physical Activity. For sections that have 9 or 10 questions (i.e., Portions, Fruits and Vegetables, Usual Physical Activity), the SOC is determined by using the third lowest stage for the behavioral items. For sections that have 11 questions (Dietary Fat), the SOC is determined by using the fourth lowest stage indicated for the behavioral items. Items answered "N/A" or left blank are scored as a "1". | change from Baseline to intervention completion at 6 months | |
Secondary | Change in physical activity habits | Change in physical activity habits as measured by the Modifiable Activity Questionnaire (MAQ). This measure is a self-reported questionnaire that records frequency and duration of different levels of physical activity. The MAQ assesses current physical activity during both work and leisure time, as well as some inactivity. The hours per week of all activities are summed to determine total hours per week. | change from Baseline to intervention completion at 6 months |
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