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:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2025-12-24 @ 10:52 PM
NCT ID:
NCT01177969
Eligibility Criteria:
Inclusion Criteria:
* Outpatient adolescents with ASD (see below) between the ages 11-14 years.
* Meets criteria for a diagnosis of autism, Asperger syndrome (AS), or Pervasive Developmental Disorder Not Otherwise Specified .
* Meets criteria for a diagnosis of one of the following anxiety disorders: separation anxiety disorder (SAD), generalized anxiety disorder (GAD), social phobia, or obsessive compulsive disorder (OCD).
* Child has a Full Scale and Verbal Comprehension IQ≥85.
Exclusion Criteria:
* Receiving concurrent psychotherapy, social skills training, or behavioral interventions (e.g., applied behavior analysis). Families will have the option of discontinuing such services to enroll in the study.
* Has started an antidepressant within 12 weeks before study enrollment or an antipsychotic 6 weeks before study enrollment.
* Has changed established psychotropic medications (e.g., antidepressants, anxioloytics) within 8 weeks before study enrollment (6 weeks for antipsychotic).
* Is currently suicidal or has been actively suicidal in the last 6 months.
* Has been diagnosed with bipolar, schizophrenia or schizoaffective disorders; or Substance abuse in past 6 months.
* Presence of a significant and/or unstable medical illness which might lead to hospitalization during the study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
11 Years
Maximum Age:
14 Years
Study:
NCT01177969
Study Brief:
Protocol Section:
NCT01177969