Stepped-Care Cognitive-Behavioral Treatment for Youth With ASD and Anxiety
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03720795|
Recruitment Status : Recruiting
First Posted : October 25, 2018
Last Update Posted : September 16, 2020
|Condition or disease||Intervention/treatment||Phase|
|Cognitive Behavioral Therapy Autism Spectrum Disorder Anxiety Disorders Obsessive-Compulsive Disorder Social Anxiety Disorder Generalized Anxiety Disorder Specific Phobia||Behavioral: Stepped Care CBT||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Single group observational.|
|Masking:||None (Open Label)|
|Masking Description:||The rater is unaware of treatment status, that is if the child continues to receive treatment after Step 1 (versus being in maintenance).|
|Official Title:||Parent-Led Stepped-Care Cognitive-Behavioral Treatment for Youth With ASD and Co-occurring Anxiety|
|Actual Study Start Date :||February 1, 2019|
|Estimated Primary Completion Date :||December 30, 2021|
|Estimated Study Completion Date :||December 31, 2021|
Stepped Care CBT
Stepped Care CBT consists of two main steps. Step One involves 4 parent-led, therapist-assisted treatment sessions, up to 45 minutes each, over an 8-week period. Participants who do not show significant improvement in symptom severity at the end of Step One, are then 'stepped up' to receive Step Two, which involves 12 weekly, therapist-led, parent-assisted treatment sessions, up to 60 minutes each.
Behavioral: Stepped Care CBT
Stepped Care CBT is a multi-method, parent-led approach, consisting of two main steps. Step one involves a "low-intensity" delivery of CBT, consisting of more flexible, parent-led, at-home treatment. Participants who do not show improvement in symptom severity at the end of Step One, are then "stepped up" to receive Step Two. Step two involves a "high intensity" delivery of CBT, consisting of therapist-led, parent-assisted weekly treatment sessions.
- 6-item Pediatric Anxiety Rating Scale [ Time Frame: 7 days ]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 30.
- Clinical Global Impression-Improvement [ Time Frame: 7 days ]Clinician rated child psychopathology improvement since initial rating. A single item is scored 0-6 (0 = very much worse; 6= very much improved).
- Clinical Global Impression-Severity [ Time Frame: 7 days ]Clinician rated child psychopathology severity rating. A single item is scored 0-6 (0= no illness; 6= extremely severe symptoms).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03720795
|Contact: Eric Storch, Ph.D.||email@example.com|
|Contact: Sophie Schneider, Ph.D.||firstname.lastname@example.org|
|United States, Texas|
|Baylor College of Medicine||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Ana C Ramirez 713-798-2465 email@example.com|
|Principal Investigator: Eric A Storch, PhD|
|Sub-Investigator: Robin P Kochel, PhD|
|Sub-Investigator: Leandra Berry, PhD|