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Parent-Led Cognitive-Behavioral Teletherapy for Anxiety in Youth With ASD

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: NCT04111874
Recruitment Status : Recruiting
First Posted : October 1, 2019
Last Update Posted : September 16, 2020
Sponsor:
Information provided by (Responsible Party):
Eric Alan Storch, Baylor College of Medicine

Brief Summary:
This study implements an anxiety-focused, parent-led, therapist-assisted cognitive behavioral teletherapy for parents of youth with ASD and anxiety.

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

Detailed Description:
Anxiety disorders affect 50-80% of children with autism spectrum disorder (ASD) and are associated with significant life impairment and worsening trajectory without treatment. The most effective psychotherapy for anxiety in youth with and without ASD is cognitive behavioral therapy (CBT), but many families are not able to access CBT due to the cost, practicalities of attending treatment sessions, and limited availability of trained therapists. Alternative models of service delivery are greatly needed, with particular promise of parent-led therapist-assisted (PLTA) models and telehealth delivery formats. Parents may benefit from additional information regarding how to optimize the delivery of CBT for youths with ASD given the potential impact of ASD symptomology on core CBT skills. Thus, this project aims to improve access to anxiety-focused Parent-Led Therapist-Assisted CBT for parents of youth with ASD. Parent-led low-intensity treatment models can improve accessibility, efficiency, and mental health treatment cost. Lower intensity treatment models provide a treatment option that is less costly and burdensome for parents; it is understood that some individuals will respond to the first step and others will require additional treatment to achieve anxiety reduction. However, understanding how many families, and which families, can benefit from a lower intensity model has dramatic benefits for improving access, allocating more intensive services for those most in need, and reducing barriers (e.g., distance). Thus, this study will examine the effectiveness of two anxiety-focused PTLA CBT telehealth models: 1) low-intensity therapist assistance (LTA) and 2) standard therapist assistance (STA). Overall, this study will provide important information regarding the potential benefits of two different approaches to parent-led interventions for youth with ASD and anxiety when delivered via telehealth.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 190 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.

  2. 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).


Secondary Outcome Measures :
  1. 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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   7 Years to 13 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Child is between the ages 7-13 years at consent/assent.
  • The child meets criteria for ASD.
  • The child meets criteria for clinically significant anxiety and/or OCD symptoms.
  • Anxiety and/or OCD is the primary presenting problem.
  • One parent/guardian is able and willing to participate.
  • The child has a Full Scale and Verbal Comprehension Intelligence Quotient >70.
  • The child is able to communicate verbally.
  • Participants must reside in Texas and parents must be in the state of Texas when taking calls.

Exclusion Criteria:

  • The child has a diagnosis of lifetime DSM-5 bipolar disorder, psychotic disorder, and/or intellectual disability.
  • The child has severe current suicidal/homicidal ideation and/or self-injury requiring medical intervention.
  • The child is receiving concurrent psychotherapy for anxiety.
  • Initiation of a psychotropic medication less than 4 weeks prior to study enrollment or a stimulant/psychoactive medication less than 2 weeks prior to study enrollment.

Information from the National Library of Medicine

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


Contacts
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Contact: Eric Storch, Ph.D. 713-798-1495 eric.storch@bcm.edu
Contact: Sophie Schneider, Ph.D. 713-798-1495 sophie.schneider@bcm.edu

Locations
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United States, Texas
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Saira Weinzimmer    713-798-8563    Saira.Weinzimmer@bcm.edu   
Sponsors and Collaborators
Baylor College of Medicine
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Responsible Party: Eric Alan Storch, Principal Investigator, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT04111874    
Other Study ID Numbers: H45203
First Posted: October 1, 2019    Key Record Dates
Last Update Posted: September 16, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Disease
Anxiety Disorders
Autism Spectrum Disorder
Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Phobia, Social
Pathologic Processes
Mental Disorders
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Personality Disorders
Phobic Disorders