Group Depression Treatment for Autistic Youth

Sponsor
Vanderbilt University Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT05430022
Collaborator
(none)
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Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Autism-adapted Group Cognitive Behavioral Therapy
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
32 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Pilot, nonrandomized trial of a behavioral intervention for autistic adolescents.Pilot, nonrandomized trial of a behavioral intervention for autistic adolescents.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Adapted Cognitive Behavioral Therapy for Depression in Autistic Youth: A Pilot Trial
Actual Study Start Date :
Jul 21, 2021
Anticipated Primary Completion Date :
Jun 30, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Autism-adapted Group Cognitive Behavioral Therapy

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.

Behavioral: Autism-adapted Group Cognitive Behavioral Therapy
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.

Outcome Measures

Primary Outcome Measures

  1. Severity of adolescent depressive symptoms, self-report [Baseline to 6 months]

    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.

  2. Severity of adolescent depressive symptoms, parent-report [Baseline to 6 months]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
11 Years to 17 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Vanderbilt University Medical Center Nashville Tennessee United States 37212

Sponsors and Collaborators

  • Vanderbilt University Medical Center

Investigators

  • Principal Investigator: Jessica M Schwartzman, PhD, Vanderbilt University Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jessica Schwartzman, PhD, Assistant Professor, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier:
NCT05430022
Other Study ID Numbers:
  • 201725
First Posted:
Jun 24, 2022
Last Update Posted:
Jun 24, 2022
Last Verified:
Jun 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 24, 2022