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Group Depression Treatment for Autistic Youth

Primary Purpose

Autism Spectrum Disorder, Depression, Suicidal Ideation

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Autism-adapted Group Cognitive Behavioral Therapy
Sponsored by
Vanderbilt University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder

Eligibility Criteria

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

Adolescent Inclusion Criteria:

  • 10 to 17 years of age (middle or high school)
  • Diagnosis of Autism Spectrum Disorder
  • Average to above-average intellectual functioning
  • Willing to attend study visits and participate in weekly group intervention

Adolescent Exclusion Criteria:

  • No diagnosis of Autism Spectrum Disorder
  • Comorbid intellectual impairment (FSIQ < 70), as the study protocol and assessments are not designed, and thus not appropriate, for this population.
  • Severe medical conditions (e.g., uncontrolled seizures) and/or genetic disorders (e.g., Fragile X syndrome).
  • Unwilling to attend study visits or weekly group intervention sessions.
  • Significant aggression to self/others
  • Significant active suicidal thoughts with intent/plan requiring higher-level care

Parent Inclusion Criteria:

  • At least 18 years of age and a parent or legal guardian of the adolescent participant with ASD.
  • Able to provide current and historical observations of the functioning of the participant with ASD based on self report from parent. Similarly, parent must live in close proximity to and have frequent contact with the participant with ASD.
  • Willing to complete questionnaires about their own functioning and that of their child with ASD.

Parent Exclusion Criteria:

-Parents of adolescents with ASD who do not have frequent contact with the participant with ASD and/or unable to provide current and historical observations of the functioning of the participant with ASD.

Sites / Locations

  • Vanderbilt University Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Autism-adapted Group Cognitive Behavioral Therapy

Arm Description

Autistic adolescents (11-17 years old; middle and high school) with depression will participate in a 12-week group intervention, autism-adapted Cognitive Behavioral Therapy, to increase perception and understanding of self and to decrease the severity of depressive symptoms.

Outcomes

Primary Outcome Measures

Severity of adolescent depressive symptoms, self-report
Self-reported severity of depressive symptoms by autistic adolescents on the Revised Children's Anxiety and Depression Scale (RCADS). The RCADS is a 47-item scale with each item scored from 0-3, with a total possible raw score of 0-141, with higher scores indicating higher internalizing symptoms. The depression subscale of the RCADS is comprised of 10 items. Raw scores are converted to grade-based standardized T-scores (mean of 50, standard deviation of 10), and T-scores greater than 59 indicate clinically-significant symptoms. The RCADS has been validated for use with autistic youth.
Severity of adolescent depressive symptoms, parent-report
Parent-reported severity of adolescent depressive symptoms on the Revised Children's Anxiety and Depression Scale (RCADS). The RCADS is a 47-item scale with each item scored from 0-3, with a total possible raw score of 0-141, with higher scores indicating higher internalizing symptoms in adolescents. The depression subscale of the RCADS is comprised of 10 items. Raw scores are converted to grade-based standardized T-scores (mean of 50, standard deviation of 10), and T-scores greater than 59 indicate clinically-significant symptoms. The RCADS has been validated for use with autistic youth.

Secondary Outcome Measures

Full Information

First Posted
June 17, 2022
Last Updated
May 22, 2023
Sponsor
Vanderbilt University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05430022
Brief Title
Group Depression Treatment for Autistic Youth
Official Title
Adapted Cognitive Behavioral Therapy for Depression in Autistic Youth: A Pilot Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
July 21, 2021 (Actual)
Primary Completion Date
February 3, 2023 (Actual)
Study Completion Date
April 3, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center

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
Higher rates of depression are reported by autistic adolescents as compared to their non-autistic peers, which is problematic given adverse outcomes (e.g., negative self-esteem, lower academic performance) that are associated with depression. Despite the alarming rates of depression in autistic youth and associated safety concerns, few treatments have been developed. In this study, we investigate the feasibility, acceptability, and preliminary efficacy of an autism-adapted group cognitive-behavioral treatment for autistic adolescents (11-17 years old; middle and high school) in a pilot, nonrandomized trial. Specifically, we aim to increase adolescents' perception and understanding of self, including autistic identity, in order to treat depression. Intervention design and implementation were guided by autistic self-advocates and parents.
Detailed Description
Higher rates of depression and suicidal thoughts are reported by autistic adolescents as compared to their non-autistic peers, which is problematic given adverse outcomes (e.g., negative self-esteem, lower academic performance) that are associated with depression. Despite the alarming rates of depression in autistic youth, few interventions have been developed or tested to reduce depression in this at-risk population. An evidence-based intervention for depression in non-autistic adolescents is Cognitive Behavioral Therapy (CBT), which CBT has strong research support for treating depression in non-autistic adolescents according to the American Psychological Association (APA). Autism-adapted CBT programs for anxiety and OCD have outperformed standard CBT approaches for autistic youth; however, autism-adapted CBT programs for depression in autistic adolescents have not been developed with stakeholders nor tested in a clinical setting. To address this gap, an adapted CBT group intervention for autistic adolescents (11-17 years old; middle and high school) with depression was designed in collaboration with autistic stakeholders. In the present study, the feasibility, acceptability, and preliminary efficacy of this 12-week group intervention in improving perception and understanding of self and depressive symptoms will be examined in a pilot, nonrandomized trial with pretest-posttest design. Groups will occur in the Outpatient Clinic of the Department of Psychiatry and Behavioral Sciences at the Vanderbilt University Medical Center (VUMC), and study measures will be administered to adolescents and their parents at four timepoints: baseline (week 0), midpoint (week 6), post (week 12), and follow-up (week 24). Study measures include parent- and self-report measures of adolescent well-being (e.g., perception of self, quality of life, etc.) and clinical interviews of psychiatric symptoms (e.g., depressive symptoms, suicidal thoughts). The significance and size of intervention effects on emotional and behavioral outcomes will be measured using one-way ANOVAs and linear mixed models. If predicted results occur, it will provide information on the feasibility and acceptability of this group intervention, with preliminary empirical support for its efficacy in improving perception and understanding of self and reducing the severity of depressive symptoms in autistic adolescents.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder, Depression, Suicidal Ideation, Self Esteem

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Pilot, nonrandomized trial of a behavioral intervention for autistic adolescents.
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Autism-adapted Group Cognitive Behavioral Therapy
Arm Type
Experimental
Arm Description
Autistic adolescents (11-17 years old; middle and high school) with depression will participate in a 12-week group intervention, autism-adapted Cognitive Behavioral Therapy, to increase perception and understanding of self and to decrease the severity of depressive symptoms.
Intervention Type
Behavioral
Intervention Name(s)
Autism-adapted Group Cognitive Behavioral Therapy
Intervention Description
The autism-adapted Group Cognitive Behavioral Therapy (CBT) was designed by the PI and research team in collaboration with autistic stakeholders (i.e., adults, parents, researchers). It is a 12-week group intervention (90 min) delivered on a weekly basis in an outpatient psychiatry clinic by licensed clinical psychologists and psychology trainees. Each group is comprised of 8-9 autistic adolescents (11-17 years old; middle and high school) with depression. The intervention targets adolescents' perception and understanding of self, including autistic identity, through a series of cognitive-behavioral approaches including psychoeducation, emotion regulation, cognitive distortions, cognitive restructuring, behavioral rehearsals, and weekly homework assignments.
Primary Outcome Measure Information:
Title
Severity of adolescent depressive symptoms, self-report
Description
Self-reported severity of depressive symptoms by autistic adolescents on the Revised Children's Anxiety and Depression Scale (RCADS). The RCADS is a 47-item scale with each item scored from 0-3, with a total possible raw score of 0-141, with higher scores indicating higher internalizing symptoms. The depression subscale of the RCADS is comprised of 10 items. Raw scores are converted to grade-based standardized T-scores (mean of 50, standard deviation of 10), and T-scores greater than 59 indicate clinically-significant symptoms. The RCADS has been validated for use with autistic youth.
Time Frame
Baseline to 6 months
Title
Severity of adolescent depressive symptoms, parent-report
Description
Parent-reported severity of adolescent depressive symptoms on the Revised Children's Anxiety and Depression Scale (RCADS). The RCADS is a 47-item scale with each item scored from 0-3, with a total possible raw score of 0-141, with higher scores indicating higher internalizing symptoms in adolescents. The depression subscale of the RCADS is comprised of 10 items. Raw scores are converted to grade-based standardized T-scores (mean of 50, standard deviation of 10), and T-scores greater than 59 indicate clinically-significant symptoms. The RCADS has been validated for use with autistic youth.
Time Frame
Baseline to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Adolescent Inclusion Criteria: 10 to 17 years of age (middle or high school) Diagnosis of Autism Spectrum Disorder Average to above-average intellectual functioning Willing to attend study visits and participate in weekly group intervention Adolescent Exclusion Criteria: No diagnosis of Autism Spectrum Disorder Comorbid intellectual impairment (FSIQ < 70), as the study protocol and assessments are not designed, and thus not appropriate, for this population. Severe medical conditions (e.g., uncontrolled seizures) and/or genetic disorders (e.g., Fragile X syndrome). Unwilling to attend study visits or weekly group intervention sessions. Significant aggression to self/others Significant active suicidal thoughts with intent/plan requiring higher-level care Parent Inclusion Criteria: At least 18 years of age and a parent or legal guardian of the adolescent participant with ASD. Able to provide current and historical observations of the functioning of the participant with ASD based on self report from parent. Similarly, parent must live in close proximity to and have frequent contact with the participant with ASD. Willing to complete questionnaires about their own functioning and that of their child with ASD. Parent Exclusion Criteria: -Parents of adolescents with ASD who do not have frequent contact with the participant with ASD and/or unable to provide current and historical observations of the functioning of the participant with ASD.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jessica M Schwartzman, PhD
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States

12. IPD Sharing Statement

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Group Depression Treatment for Autistic Youth

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