search
Back to results

Transdiagnostic Behavioral Therapy for Anxiety and Depression in Autistic Adolescents

Primary Purpose

Anxiety, Depression, Emotional Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transdiagnostic cognitive behavioral therapy (CBT)
Treatment as usual
Sponsored by
Baylor College of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety focused on measuring Cognitive behavioral therapy, CBT, exposure therapy, behavioral activation

Eligibility Criteria

12 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Child is between the ages of 12-17 at consent/assent. The child meets criteria for autism spectrum disorder using evidence-based assessment approaches (e.g., Autism Diagnostic Observation Schedule-Second Edition; Childhood Autism Rating Scale-Second Edition). The child meets criteria for clinically significant anxiety and/or depression symptoms based on elevated scores on the Pediatric Anxiety Rating Scale modified for Autism Spectrum Disorder (>11) and/or the Children's Depression Rating Scale-Revised (>39). Anxiety/depressive disorder is the primary presenting problem as determined by administration of the Mini International Neuropsychiatric Interview One parent/guardian is able and willing to participate. The parent/guardian is 18 years or older. Both parent and child can read and/or understand English. Both parent and child reside in Texas. Exclusion Criteria: The child has a diagnosis of psychotic disorder and/or conduct disorder. The child has severe suicidal/homicidal ideation and/or self-injury requiring immediate intervention and/or a higher level of care. The child has limited verbal communication abilities. The child is receiving concurrent psychotherapy for anxiety/depression. The child has initiated psychotropic medications within 12 weeks of assessments (or 4 weeks for stimulants/benzodiazepines) or during therapy, and/or has changed dosage of psychotropic medication within 6 weeks of assessment (or 2 weeks for stimulants/benzodiazepines) or during therapy.

Sites / Locations

  • Baylor Psychiatry ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Transdiagnostic cognitive behavioral therapy

Treatment as usual

Arm Description

Outcomes

Primary Outcome Measures

Revised Children's Anxiety and Depression Scale - Parent-Report
Parent-rated child anxiety and depression severity. It is a 47-item scale. Each item is scored on a 0 ("never") to 3 ("always") scale (higher scores correspond to greater severity), yielding a total between 0 and 141.
Clinical Global Impression - Improvement
Clinician-rated child internalizing symptom improvement since initial rating. A single item is scored 0-6 (0 = very much worse; 6 = very much improved).
Clinical Global Impression - Severity of Illness
Clinician-rated child internalizing symptom overall severity. A single item is scored 0-6 (0 = no illness; 6 = extremely severe symptoms).

Secondary Outcome Measures

Revised Children's Anxiety and Depression Scale - Self-Report
Child rated anxiety and depression severity. It is a 47-item scale. Each item is scored on a 0 ("never") to 3 ("always") scale (higher scores correspond to greater severity), yielding a total between 0 and 141.
Pediatric Anxiety Rating Scale modified for Autism
Clinician-rated child anxiety severity. The rating scale first includes a checklist of common anxiety symptoms that are rated as present/absent and is followed by a severity rating scale with five Likert scale items. Each severity item is scored on a 0 to 5 scale, (higher scores correspond to greater severity), yielding a total between 0 and 30.
Children's Depression Rating Scale, Revised
Clinician-rated child depression severity. It is a 17-item scale, with items ranging from 1 to 5 or 1 to 7 (higher scores correspond to greater severity), yielding a total between 17 and 113.

Full Information

First Posted
February 8, 2023
Last Updated
May 9, 2023
Sponsor
Baylor College of Medicine
Collaborators
Texas Higher Education Coordinating Board
search

1. Study Identification

Unique Protocol Identification Number
NCT05738967
Brief Title
Transdiagnostic Behavioral Therapy for Anxiety and Depression in Autistic Adolescents
Official Title
Transdiagnostic Behavioral Therapy for Anxiety and Depression in Autistic Adolescents
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 15, 2023 (Actual)
Primary Completion Date
May 31, 2025 (Anticipated)
Study Completion Date
May 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baylor College of Medicine
Collaborators
Texas Higher Education Coordinating Board

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study tests the effectiveness of a transdiagnostic cognitive behavioral therapy for autistic youth with anxiety and/or depression.
Detailed Description
About 1 in 54 adolescents are estimated to be on the autism spectrum, with over half suffering from anxiety or depressive disorders. These disorders contribute to suicidality, family stress, social impairments, and difficulties transitioning to adulthood among autistic youth. Given the frequency of anxiety and depressive disorders among autistic adolescents and the increased risk of impairment, developing effective treatments for anxiety and depression tailored to this population is a top priority. Transdiagnostic cognitive behavioral therapy (CBT) for other populations, including typically developing adolescents, may confer broader benefits than disorder-specific CBT and facilitate broader dissemination and implementation. However, there has been little research conducted on transdiagnostic treatments among autistic adolescents. Thus, this study proposes to address this gap by testing transdiagnostic CBT for autistic adolescents with anxiety and depression. The study involves two phases: 1) a pilot intervention; and 2) a randomized controlled trial. The pilot intervention will involve 12 adolescent-caregiver dyads to further refine the treatment model and its assessment measures. The randomized trial will involve 100 adolescent-caregiver dyads to further evaluate the clinical efficacy of the treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Depression, Emotional Disorder, Autism
Keywords
Cognitive behavioral therapy, CBT, exposure therapy, behavioral activation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
112 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Transdiagnostic cognitive behavioral therapy
Arm Type
Experimental
Arm Title
Treatment as usual
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Transdiagnostic cognitive behavioral therapy (CBT)
Other Intervention Name(s)
CBT
Intervention Description
Adolescent-caregiver dyads will will participate in CBT focused on exposure therapy and behavioral activation. It will also include flexible incorporation of emotion-focused coping and adaptations for autism.
Intervention Type
Behavioral
Intervention Name(s)
Treatment as usual
Other Intervention Name(s)
TAU
Intervention Description
Adolescent-caregiver dyads will participate in coordinated referrals to the community. They may receive psychotherapy and/or initiate or change current psychiatric medication (if applicable).
Primary Outcome Measure Information:
Title
Revised Children's Anxiety and Depression Scale - Parent-Report
Description
Parent-rated child anxiety and depression severity. It is a 47-item scale. Each item is scored on a 0 ("never") to 3 ("always") scale (higher scores correspond to greater severity), yielding a total between 0 and 141.
Time Frame
7 days
Title
Clinical Global Impression - Improvement
Description
Clinician-rated child internalizing symptom improvement since initial rating. A single item is scored 0-6 (0 = very much worse; 6 = very much improved).
Time Frame
7 days
Title
Clinical Global Impression - Severity of Illness
Description
Clinician-rated child internalizing symptom overall severity. A single item is scored 0-6 (0 = no illness; 6 = extremely severe symptoms).
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Revised Children's Anxiety and Depression Scale - Self-Report
Description
Child rated anxiety and depression severity. It is a 47-item scale. Each item is scored on a 0 ("never") to 3 ("always") scale (higher scores correspond to greater severity), yielding a total between 0 and 141.
Time Frame
7 days
Title
Pediatric Anxiety Rating Scale modified for Autism
Description
Clinician-rated child anxiety severity. The rating scale first includes a checklist of common anxiety symptoms that are rated as present/absent and is followed by a severity rating scale with five Likert scale items. Each severity item is scored on a 0 to 5 scale, (higher scores correspond to greater severity), yielding a total between 0 and 30.
Time Frame
7 days
Title
Children's Depression Rating Scale, Revised
Description
Clinician-rated child depression severity. It is a 17-item scale, with items ranging from 1 to 5 or 1 to 7 (higher scores correspond to greater severity), yielding a total between 17 and 113.
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Child is between the ages of 12-17 at consent/assent. The child meets criteria for autism spectrum disorder using evidence-based assessment approaches (e.g., Autism Diagnostic Observation Schedule-Second Edition; Childhood Autism Rating Scale-Second Edition). The child meets criteria for clinically significant anxiety and/or depression symptoms based on elevated scores on the Pediatric Anxiety Rating Scale modified for Autism Spectrum Disorder (>11) and/or the Children's Depression Rating Scale-Revised (>39). Anxiety/depressive disorder is the primary presenting problem as determined by administration of the Mini International Neuropsychiatric Interview One parent/guardian is able and willing to participate. The parent/guardian is 18 years or older. Both parent and child can read and/or understand English. Both parent and child reside in Texas. Exclusion Criteria: The child has a diagnosis of psychotic disorder and/or conduct disorder. The child has severe suicidal/homicidal ideation and/or self-injury requiring immediate intervention and/or a higher level of care. The child has limited verbal communication abilities. The child is receiving concurrent psychotherapy for anxiety/depression. The child has initiated psychotropic medications within 12 weeks of assessments (or 4 weeks for stimulants/benzodiazepines) or during therapy, and/or has changed dosage of psychotropic medication within 6 weeks of assessment (or 2 weeks for stimulants/benzodiazepines) or during therapy.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andrew G Guzick, Ph.D.
Phone
713-798-3080
Email
andrew.guzick@bcm.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Eric A Storch, Ph.D.
Phone
713-798-3080
Email
eric.storch@bcm.edu
Facility Information:
Facility Name
Baylor Psychiatry Clinic
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric Storch, PhD
Email
eric.storch@bcm.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
We plan on publishing the study description, protocol/procedures, and raw data on an OSF website once primary results are published.
IPD Sharing Time Frame
Data will be available once the primary results are published in a peer-reviewed journal
Citations:
PubMed Identifier
28423145
Citation
Weersing VR, Brent DA, Rozenman MS, Gonzalez A, Jeffreys M, Dickerson JF, Lynch FL, Porta G, Iyengar S. Brief Behavioral Therapy for Pediatric Anxiety and Depression in Primary Care: A Randomized Clinical Trial. JAMA Psychiatry. 2017 Jun 1;74(6):571-578. doi: 10.1001/jamapsychiatry.2017.0429.
Results Reference
background
PubMed Identifier
21735077
Citation
van Steensel FJ, Bogels SM, Perrin S. Anxiety disorders in children and adolescents with autistic spectrum disorders: a meta-analysis. Clin Child Fam Psychol Rev. 2011 Sep;14(3):302-17. doi: 10.1007/s10567-011-0097-0.
Results Reference
background
PubMed Identifier
29497980
Citation
Hudson CC, Hall L, Harkness KL. Prevalence of Depressive Disorders in Individuals with Autism Spectrum Disorder: a Meta-Analysis. J Abnorm Child Psychol. 2019 Jan;47(1):165-175. doi: 10.1007/s10802-018-0402-1.
Results Reference
background
PubMed Identifier
26655958
Citation
Chu BC, Crocco ST, Esseling P, Areizaga MJ, Lindner AM, Skriner LC. Transdiagnostic group behavioral activation and exposure therapy for youth anxiety and depression: Initial randomized controlled trial. Behav Res Ther. 2016 Jan;76:65-75. doi: 10.1016/j.brat.2015.11.005. Epub 2015 Nov 19.
Results Reference
background
PubMed Identifier
31190198
Citation
Uljarevic M, Hedley D, Rose-Foley K, Magiati I, Cai RY, Dissanayake C, Richdale A, Trollor J. Anxiety and Depression from Adolescence to Old Age in Autism Spectrum Disorder. J Autism Dev Disord. 2020 Sep;50(9):3155-3165. doi: 10.1007/s10803-019-04084-z.
Results Reference
background
PubMed Identifier
31755906
Citation
Wood JJ, Kendall PC, Wood KS, Kerns CM, Seltzer M, Small BJ, Lewin AB, Storch EA. Cognitive Behavioral Treatments for Anxiety in Children With Autism Spectrum Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2020 May 1;77(5):474-483. doi: 10.1001/jamapsychiatry.2019.4160.
Results Reference
background

Learn more about this trial

Transdiagnostic Behavioral Therapy for Anxiety and Depression in Autistic Adolescents

We'll reach out to this number within 24 hrs