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 @ 4:36 PM
Ignite Modification Date:
2025-12-24 @ 4:36 PM
NCT ID:
NCT01727466
Eligibility Criteria:
Inclusion criteria:
* Clinicians must (1) be at the level of graduate student (or higher) in either a masters or doctoral program in clinical, counseling or school psychology; and (2)be working in an outpatient clinical setting serving children with ASD
* Children must (1) be 8-14 years of age; (2) living with someone who can give informed consent to participate;
* Children must have a diagnosis of ASD as defined by (a) Autism Diagnostic Observation Schedule (ADOS; Lord et al. 1999) score above spectrum cutoff; (b) Social Communication Questionnaire (SCQ; Berument et al. 1999) score above cutoff; and (c) clinical diagnosis of an ASD as determined by a review of history and current clinical presentation by a clinical psychologist and assigning one of the following diagnoses: Autistic Disorder, Asperger's Disorder, or Pervasive Developmental Disorder - Not Otherwise Specified.
* Children must have an estimated Verbal IQ of 80 or above as determined through standardized cognitive testing using the Wechsler Abbreviated Scales of Intelligence (WASI; Wechsler, 2002), or an equivalent measure of intelligence that has been administered within the past two years, and attempts to engage verbally with the examiner during the administration of Module 3 of the ADOS.
* Children must be able to read at a mid-2nd-grade level: Many activities involve narrative approaches and early reading is a pre-requisite skill for this intervention package; (as assessed by the Letter-Word Identification and Reading Comprehension subtests of the Woodcock Johnson Achievement Tests - Third Edition; WJ-III; Woodcock, McGrew, \& Mather, 2001).
* Children must evince clinically significant symptoms of either , SAD, GAD, or SP anxiety and this impairment is "primary" or more functionally significant than another disorder (such as depression) as determined by the clinician evaluator. Children with clinically significant scores on SpP will also be included, although SpP cannot be the sole anxiety diagnosis for the child.
* Parents must (1) be the parent of a child with ASD and clinical anxiety as defined above and can give consent for the child to participate in the study; and (2) include men and women between the ages of 24-65.
Exclusion Criteria:
* Clinician-trainees: (1) Inability to attend at least 11/14 group sessions
* Children: (1) child is not fluent in English; (2) family cannot commit to having a minimum of 1 parent and 1 child attending 11 of 14 sessions within the intervention period; (3) child presents with psychosis, severe aggressive behavior, or other severe clinical symptoms that require more intensive treatment such as day treatment or hospitalization; (4) family plans to seek additional psychosocial treatment for anxiety during enrollment through treatment; (5) child is not able to separate from parent for a minimum of 30 minutes within the qualifying sessions; Because the parent and child interventions occur simultaneously, if a child has significant issues separating from the parent, it makes it difficult for the parent to participate in their portion of the assessment.
* Parents: (1) Parent is not fluent in English; (2) Parent is unable to attend 11/14 sessions within the intervention period
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
8 Years
Maximum Age:
14 Years
Study:
NCT01727466
Study Brief:
Protocol Section:
NCT01727466