Parent-Led Cognitive-Behavioral Teletherapy for Anxiety in Youth With ASD
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|ClinicalTrials.gov Identifier: NCT04111874|
Recruitment Status : Recruiting
First Posted : October 1, 2019
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: Cognitive Behavioral Teletherapy LTA Behavioral: Cognitive Behavioral Teletherapy STA||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||190 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Parent-Led Cognitive-Behavioral Teletherapy for Anxiety in Youth With ASD|
|Actual Study Start Date :||July 30, 2019|
|Estimated Primary Completion Date :||December 31, 2021|
|Estimated Study Completion Date :||December 31, 2021|
Experimental: Low-Intensity Therapist Assistance (LTA)
Parents will receive four 30-minute supportive video calls with a therapist over the 12 weeks of treatment.
Behavioral: Cognitive Behavioral Teletherapy LTA
Participating families will receive a copy of the book 'Helping Your Anxious Child, 2nd Edition', as well as the companion parent and child workbooks, to use at home and in session with the therapist. During each of the four videoconferencing sessions, therapists will serve to provide encouragement and support as the parent works through the program independently.
Active Comparator: Standard Therapist Assistance (STA)
Parents will receive ten 60-minute supportive video calls with a therapist over the 12 weeks of treatment.
Behavioral: Cognitive Behavioral Teletherapy STA
Participating families will also receive a copy of the book 'Helping Your Anxious Child, 2nd Edition', as well as the companion parent and child workbooks, to use at home and in session with the therapist. During each of the ten videoconferencing sessions, therapists will guide the parent through the implementation of the program, including explaining materials, assisting to develop planned therapy activities with the child, and problem-solving as needed.
- 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): NCT04111874
|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: Saira Weinzimmer 713-798-8563 Saira.Weinzimmer@bcm.edu|