Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:42 AM
Ignite Modification Date:
2025-12-25 @ 4:42 AM
NCT ID:
NCT03047018
Eligibility Criteria:
Inclusion Criteria:
* Diagnosed with ASD using DSM-5 criteria, and clinically significant SCQ score.
* Children with mild to moderate food selectivity, as reflected by a) a diet involving at least 6 food items, b) accepting at least one fruit or vegetable as measured by the Food Preference Inventory (FPI), and c) engaging in low mealtime behavior problems on Brief Autism Mealtime Behavior Inventory (BAMBI) Food Refusal subscale
* Child with a clinic-confirmed body mass index (BMI) percentile in the obese range (i.e., \> 95th percentile)
* Parent (primary caregiver) who agrees to participate and attend treatment sessions
* Participating parent able to speak, understand, read, and write in English (assessments, curriculum materials and instructions are in English)
Exclusion Criteria:
* Children with severe feeding problems (e.g., \< 5 preferred foods as measured by the FPI) or complex medical issues (e.g., gastrostomy-tube or formula dependent) who require a different treatment approach
* Children on medication associated with weight gain in ASD (e.g., risperidone) that has not yet stabilized (stability criteria defined as 6 months or longer i.e. child has been on medication for less than 6 months).
* Children with serious behavioral problems (i.e., aggression, tantrums, self-injury) or another psychiatric condition that requires a different treatment approach.
* Children with unstable medical conditions or those with a known associated with weight problems will not be included in this study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
5 Years
Maximum Age:
12 Years
Study:
NCT03047018
Study Brief:
Protocol Section:
NCT03047018