Anxiety, Autism Spectrum Disorder, Generalized Anxiety Disorder, Separation Anxiety, Social Anxiety Disorder of Childhood
Conditions
Keywords
cognitive behavioral therapy, children, adolescents, anxiety, Community mental health clinics
Brief summary
Anxiety is very common in autistic youth. Recently, an intervention has been created by the investigators to target these symptoms in autistic youth in a community setting. The purpose of this study is to determine the feasibility of implementing this treatment in community care centers.
Detailed description
As many as 50% of autistic youth have at least 1 anxiety disorder. Cognitive-behavioral therapy (CBT) for autistic youth is effective at treating anxiety, but access is limited. The investigators have tailored the treatment to make it more accessible to families in the participants' home communities. The purpose of this project is to investigate how feasible it is to implement Community-Based Anxiety Programs Tailored for Autism (CAPTA) in community settings.
Interventions
BEHAVIORALCognitive Behavioral Therapy
Participants will receive cognitive behavioral therapy with elements of exposure in order to target anxious behaviors.
OTHERTreatment as Usual
Participants will receive treatment as usual at a community mental health center, including receiving skills training.
Sponsors
Baylor College of Medicine
University of Pennsylvania
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcomes assessor is blinded
Intervention model description
Randomized assignment to one of two conditions
Eligibility
Sex/Gender
ALL
Age
7 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
1. The adolescent is between the ages of 7 to 17 upon enrollment with an established autism spectrum disorder diagnosis (ASD) made by a standardized assessment (e.g., Autism Diagnostic Observation Schedule-Second Edition; Childhood Autism Rating Scale-Second Edition), confirmed by the Social Communication Questionnaire (SCQ) ≥ 11 and/or total score ≥ 7 on the Autism Diagnostic Observation Schedule-2 (ADOS-2). Dr. Storch will review diagnostic reports to determine whether an appropriate ASD diagnosis has been established. 2. The adolescent has clinically elevated symptoms of anxiety based on elevated scores on the Pediatric Anxiety Rating Scale modified for Autism Spectrum Disorder (\>12). 3. Anxiety is the primary concern and the child is appropriate for intervention focus, as determined by completion of a structured psychiatric diagnostic interview (the Mini International Neuropsychiatric Interview) by an independent evaluator (IE) supervised by an experienced, licensed psychologist determines that the child is appropriate for the intervention focus. 4. Child has a verbal intelligence quotient greater than or equal to 70, as measured by the Verbal Comprehension Index of the Wechsler Intelligence Scale for Children, Fifth Edition (WISC-V). 5. One parent/guardian is able and willing to participate (i.e., available during therapy sessions, attend study assessments). 6. Child is eligible to receive services at the participating clinic. 7. Both parent and child can read and/or understand English and/or Spanish. 8. Both parent and child reside in Texas or Pennsylvania.
Exclusion criteria
* 1.) The child has a diagnosis of psychotic disorder as determined by completion of a structured psychiatric diagnostic interview (the Mini International Neuropsychiatric Interview). 2.) The child has severe current suicidal/homicidal ideation and/or self-injury requiring medical intervention (referrals will be made for appropriate clinical intervention). 3.) The child is receiving concurrent psychotherapy for anxiety. 4.) If child is taking psychotropic medication, regimen must have been started 8 weeks ago and stable for the past 4 weeks (or 2 weeks for stimulants or benzodiazepines). If appropriate, a delayed entry will be allowed so that once a child is on a stable dosage s/he may be enrolled.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pediatric Anxiety Rating Scale - ASD | baseline (before treatment), during treatment (on average 14 weeks), post-treatment (last week of treatment), 3 month follow up | Clinician-rated child anxiety severity throughout the past week. Each item is scored on a 0 to 5 scale (higher scores correspond to greater severity), yielding a total between 0 and 35. This measure has been modified for autistic youth |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anxiety Disorders Interview Schedule (ADIS-IV) with Clinical Severity Ratings | baseline (before treatment), during treatment (on average 14 weeks), post-treatment (last week of treatment), 3 month follow up | Clinician-rated diagnostic interview that includes current anxiety disorders, depression, obsessive-compulsive disorder, and related disorders. Each diagnostic category is coded as present or absent based on symptom criteria and clinical severity ratings (CSRs), which indicate the level of clinical interference. CSRs are scored on a 0-8 scale (0 = not at all; 8 = very, very much). CSRs of 4 or above indicate the clinical levels. |
| Clinical Global Impression-Improvement | baseline (before treatment), during treatment (on average 14 weeks), post-treatment (last week of treatment), 3 month follow up | Clinician-rated child psychopathology severity rating. A single item is scored 0-6 (0= very much improved; 6= very much worse). |
Countries
United States
Outcome results
None listed