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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Adolescent Inclusion Criteria:
Adolescent Exclusion Criteria:
Parent Inclusion Criteria:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Jessica M Schwartzman, PhD | Vanderbilt University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37212 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Autism-adapted Group Cognitive Behavioral Therapy (Child Ratings) | 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 decrease the severity of depressive symptoms. 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 community members (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. |
| FG001 | Autism-adapted Group Cognitive Behavioral Therapy (Parent Ratings) | 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 did not participate in therapy sessions. 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 community members (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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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24 child and parent dyads
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| ID | Title | Description |
|---|---|---|
| BG000 | Autism-adapted Group Cognitive Behavioral Therapy (Child Ratings) | 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 decrease the severity of depressive symptoms. 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 community members (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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | T-score | Baseline to 6 months |
|
Baseline to 6-months after baseline visit at end of study participation.
Systematic assessment of adolescent suicidal thoughts and/or behaviors and severity of depressive symptoms, per self- and parent-report. Assessments collected at four timepoints between the baseline study visit and 6-month follow-up study visit (i.e., end of study participation).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Autism-adapted Group Cognitive Behavioral Therapy (Child Ratings) | 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 decrease the severity of depressive symptoms. 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 community members (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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jessica Schwartzman, Assistant Professor | University of Southern California | 3232075910 | jstrendlab@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 14, 2022 | Aug 22, 2023 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 14, 2022 | May 28, 2024 | SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 15, 2021 | May 16, 2023 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D003863 | Depression |
| D059020 | Suicidal Ideation |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
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Pilot, nonrandomized trial of a behavioral intervention for autistic adolescents.
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| BG001 | Autism-adapted Group Cognitive Behavioral Therapy (Parent Ratings) | 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 did not participate in therapy sessions. 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 community members (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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Social Responsiveness Scale, Second Edition | The SRS-2 measures an individual's degree of social impairment and restricted, repetitive behaviors and/or interests in the past six months. Raw scores are converted to T-scores with a mean of 50 and a standard deviation of 10, with higher scores indicating more impairment. T-scores between 60-64 indicate "mild" social impairment and restricted, repetitive behaviors and/or interests, T-scores between 65-75 indicate "moderate" impairment, and T-scores at/above 76 indicate "severe" impairment on the SRS-2. Data were not collected for the parent population. | data were not collected for the parent population | Mean | Standard Deviation | T-score |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | T-score | Baseline to 6 months |
|
|
|
| 0 |
| 24 |
| 0 |
| 24 |
| 0 |
| 24 |
| EG001 | Autism-adapted Group Cognitive Behavioral Therapy (Parent Ratings) | 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 did not participate in therapy sessions. 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 community members (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. | 0 | 24 | 0 | 24 | 0 | 24 |
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| D001519 | Behavior |
| D013405 | Suicide |
| D016728 | Self-Injurious Behavior |
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
|
| White |
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| More than one race |
|
| Unknown or Not Reported |
|