Group Depression Treatment for Autistic Youth

NCT05430022 | Completed Results

• 1 other identifier: 201725
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorder; Depression; Suicidal Ideation; Self Esteem

Outcome Measures

Primary Outcomes (2)

• Change in 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.

  Baseline to 6 months

• Change in 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.

  Baseline to 6 months

Study Arms (2)

Autism-adapted Group Cognitive Behavioral Therapy (Child Ratings)

EXPERIMENTAL

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

Autism-adapted Group Cognitive Behavioral Therapy (Parent Ratings)

EXPERIMENTAL

One parent of each autistic adolescent (11-17 years old; middle and high school) with depression will provide ratings of their child as their child participates in a 12-week group intervention, autism-adapted Cognitive Behavioral Therapy, to decrease the severity of depressive symptoms. Parents will not participate in therapy sessions.

Behavioral: Autism-adapted Group Cognitive Behavioral Therapy

Interventions

Autism-adapted Group Cognitive Behavioral Therapy BEHAVIORAL

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.

Autism-adapted Group Cognitive Behavioral Therapy (Child Ratings); Autism-adapted Group Cognitive Behavioral Therapy (Parent Ratings)

Eligibility Criteria

• Age: 11 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.
• 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.

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder; Depression; Suicidal Ideation

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Suicide; Self-Injurious Behavior

Results Point of Contact

• Title: Dr. Jessica Schwartzman, Assistant Professor
• Organization: University of Southern California

jstrendlab@gmail.com

3232075910

Study Officials

• Jessica M Schwartzman, PhD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Pilot, nonrandomized trial of a behavioral intervention for autistic adolescents.

Study Record Dates

• First Submitted: June 17, 2022
• First Posted: June 24, 2022
• Study Start: July 21, 2021
• Primary Completion: February 3, 2023
• Study Completion: April 3, 2023
• Last Updated: November 8, 2024
• Results First Posted: November 8, 2024

Record last verified: 2024-11

Locations

US (1)