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 @ 3:27 AM
Ignite Modification Date:
2025-12-25 @ 3:27 AM
NCT ID:
NCT02088905
Eligibility Criteria:
Inclusion Criteria:
i. Outpatients between 2 years, 6 months and 6 years, 11 months of age; ii. Diagnosis of Autistic Disorder, Pervasive Developmental Disorder Not Otherwise Specified, or Asperger's Disorder based upon the Autism Diagnostic Observation Schedule and clinical evaluation by Diagnostic and Statistical Manual of Mental Disorders IV criteria; iii. Males and females; iv. Mental Age\>30 months based upon the Stanford-Binet V or Mullens \[to insure that the child possesses enough expressive language to offer opportunities for the parent to learn "verbal reflection" skills and that child is able to understand time out\]; v. Eyberg Child Behavior Inventory score greater than or equal to 120; vi. Behavior Assessment System for Children Externalizing Problem Scale T-score \>65; vii. Care provider who can reliably bring subject to clinic visits, can attend weekly PCIT sessions, can provide trustworthy ratings and interact with subject on a regular basis.
Exclusion Criteria:
i. Unstable use of psychotropic medications (no changes in dose for at least two months and no plans to change dose during the course of the study); ii. Unstable use of dietary supplements (e.g., casein-gluten free diet)(no changes in supplement dose for at least two months and no plans to change douse during the course of the study); iii. Prior involvement in PCIT or currently receiving parent training. iv. Extremely severe behavioral concerns that require immediate treatment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Months
Maximum Age:
83 Months
Study:
NCT02088905
Study Brief:
Protocol Section:
NCT02088905