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Transdiagnostic Group Behavioral Activation for Autistic Adults (GBAT)

Primary Purpose

Autism Spectrum Disorder, Depression, Anxiety, Anxiety

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Group Behavioral Activation Therapy for Autism Spectrum Disorder
Sponsored by
Rutgers, The State University of New Jersey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Be 18-40 years old
  2. Have a confirmed diagnosis of Autism Spectrum Disorders (ASD).
  3. Have access to a device (e.g., computer with a webcam or smartphone) in order to complete online surveys and participate in the telehealth videoconferencing sessions
  4. *Have a VIQ and NVIQ of 85 or above
  5. *Have at least a 6th grade reading composite
  6. *Have elevated symptoms of depression, anxiety or anger. This will be determined based on scoring above the borderline or mild threshold on at least one of 3 screening measures (MINI; ASR; DASS-21).

Exclusion Criteria:

  1. Are younger than 18 years old, or older than 40 years old (Children are excluded because the focus is on adapting GBAT for adults; Individuals above 40 are excluded to restrict the adult focus to young adults that are more likely to be in similar life stages).
  2. Do not have an ASD diagnosis (because the study as the purpose of the current research is to examine GBAT's feasibility with autistic adults).
  3. Both VIQ and NVIQ below 85 OR less than 6th grade reading level
  4. Do not have elevated scores of depression, anxiety, or anger on the symptom screening measures.
  5. Are unable to understand English fluently (because the instruments being investigated are currently only validated in English and the intervention will be delivered in English).
  6. Are currently enrolled in another behavioral therapy or psychotherapy targeting depression,
  7. the PI's clinical judgment that it would not be in the adult's best interest to be enrolled (e.g., due to factors that may affect their engagement or comfort in the group).

Sites / Locations

  • Rutgers University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

GBAT

Arm Description

10-week behavioral activation treatment group.

Outcomes

Primary Outcome Measures

Change in symptoms on the Adult Self Report (ASR)
The ASR is a an assessment of adult psychopathology (e.g., anxiety, depression symptoms). Most of the items are on a 3 point scale including: (0) Not true, (1) Somewhat or sometimes true, and (2) Very often or often true.
Change in Clinician Global Impairment rating
The CGI is a 7 point scale on which the clinician rates the severity of the client's impairment. The scale ranges from 1 (Normal, not at all ill) to 7 Extremely Ill; higher scores indicate more impairment.

Secondary Outcome Measures

Change in symptoms on the Depression Anxiety Stress Scales-21
The DASS-21 is a 21-item measure of depression and anxiety symptoms. The measure produces scores in 3 domains: depression, anxiety, and stress. The score ranges on each domain is from 0-42. Higher scores on each domain indicate more impairment/ severity.
Change in distress on Patient Health Questionnaire (PHQ-9)
The PHQ-9, assessed weekly, is a 9-item questionnaire of psychological function over the past week with all items on a "0" (not at all) to "3" (nearly every day) scale. Total scores range from 0 to 27; higher scores reflect greater levels of depressive symptoms.
Change in anxiety symptoms on the Generalized Anxiety Disorder Questionnaire (GAD-7)
The GAD-7, assessed weekly, is a 7-item questionnaire of anxiety symptoms over the past week with all items on a "0" (not at all) to "3"(nearly every day) scale. Total scores range from 0 to 21; higher scores reflect greater levels of anxiety.
Change in Adaptive Behavior Assessment System - 3 (ABAS-3)
The ABAS-3 is a measure of adaptive function that yields age-standardized scores for three domains (Conceptual, Social and Practical) and an overall Global Adaptive Composite. Each domain and the overall General Adaptive Composite result in a standard score, with a mean of 100 and a standard deviation of 15 (scores between 86 and 114 are considered "Average" on this instrument; scores under 70 are classified as "Extremely Low" relative to same aged peers). Each domain is composed of several subdomains that yield scaled scale scores (Mean=10, SD=3), with scores between 7 and 13 falling in the "Average" range.
Change in Behavioral Activation for Depression Scale
The BADS is a 25-item measure designed to assess how clients become activated over the course of Behavior Activation treatment. There are 25 questions, each rated on a seven point scale ranging from 0 to 6. There are four subscales: AC = Activation subscale [score range 0 to 42] AR = Avoidance/Rumination subscale [score range 0-48] WS = Work/School Impairment subscale [score range 0-30] SI = Social Impairment subscale [score range 0-30] Higher scores indicate a better outcome on the Activation subscale. Higher scores indicate a worse outcome on the Avoidance/Rumination subscale, Work/School Impairment subscale, and Social Impairment subscale.
Change in Idiographic target goals
Clients are asked to identify 3 goals they would like to accomplish. There are no scores or scales. Each goal is a statement shared by the client relevant to their own experiences. Target goals are sensitive to change in treatment contexts.

Full Information

First Posted
March 4, 2021
Last Updated
August 3, 2021
Sponsor
Rutgers, The State University of New Jersey
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1. Study Identification

Unique Protocol Identification Number
NCT04788212
Brief Title
Transdiagnostic Group Behavioral Activation for Autistic Adults
Acronym
GBAT
Official Title
Adaptation of a Transdiagnostic Behavioral Activation Telehealth Group for Autistic Adults
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
February 16, 2021 (Actual)
Primary Completion Date
July 8, 2021 (Actual)
Study Completion Date
July 8, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rutgers, The State University of New Jersey

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
The purpose of this study is to evaluate the feasibility, acceptability and effectiveness of a telehealth Group Behavioral Activation Therapy (GBAT) for autistic adults.
Detailed Description
Detailed Description: This study is being done to demonstrate the feasibility, acceptability and effectiveness of a telehealth Group Behavioral Activation Therapy (GBAT) for autistic adults. GBAT is intended to help adults manage stress, anxiety, down moods, and anger. Similar programs have been shown to be effective in other contexts but has not yet been used for autistic adults or delivered via telehealth. Because this is a new intervention, the investigators are interested in learning 1) whether GBAT can be done with autistic adults (feasibility), 2) what autistic adults think about GBAT (acceptability), and 3) whether GBAT is effective for helping autistic adults cope with their feelings. Results from this study will be used to inform adaptation to the intervention and planning for future studies to further explore its effectiveness. For this initial feasibility study, 8 autistic adults (18-40 years old) with VIQ and NVIQ>85, reading composite at least 6th grade level and elevated symptoms of depression, anxiety or anger will be recruited.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder, Depression, Anxiety, Anxiety, Anger

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
8 participants with autism and depression, anxiety or anger will participate
Masking
None (Open Label)
Masking Description
This is an open trial feasibility study
Allocation
N/A
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GBAT
Arm Type
Experimental
Arm Description
10-week behavioral activation treatment group.
Intervention Type
Behavioral
Intervention Name(s)
Group Behavioral Activation Therapy for Autism Spectrum Disorder
Intervention Description
This will be a modification of the Group Behavioral Activation Therapy program (Chu et al., 2009) for treatment of depression, anxiety and/or anger in autistic adults.
Primary Outcome Measure Information:
Title
Change in symptoms on the Adult Self Report (ASR)
Description
The ASR is a an assessment of adult psychopathology (e.g., anxiety, depression symptoms). Most of the items are on a 3 point scale including: (0) Not true, (1) Somewhat or sometimes true, and (2) Very often or often true.
Time Frame
10 week study period; 4 week post-treatment
Title
Change in Clinician Global Impairment rating
Description
The CGI is a 7 point scale on which the clinician rates the severity of the client's impairment. The scale ranges from 1 (Normal, not at all ill) to 7 Extremely Ill; higher scores indicate more impairment.
Time Frame
10 week study period;
Secondary Outcome Measure Information:
Title
Change in symptoms on the Depression Anxiety Stress Scales-21
Description
The DASS-21 is a 21-item measure of depression and anxiety symptoms. The measure produces scores in 3 domains: depression, anxiety, and stress. The score ranges on each domain is from 0-42. Higher scores on each domain indicate more impairment/ severity.
Time Frame
10 week study period; 4 week post-treatment
Title
Change in distress on Patient Health Questionnaire (PHQ-9)
Description
The PHQ-9, assessed weekly, is a 9-item questionnaire of psychological function over the past week with all items on a "0" (not at all) to "3" (nearly every day) scale. Total scores range from 0 to 27; higher scores reflect greater levels of depressive symptoms.
Time Frame
10 week study period
Title
Change in anxiety symptoms on the Generalized Anxiety Disorder Questionnaire (GAD-7)
Description
The GAD-7, assessed weekly, is a 7-item questionnaire of anxiety symptoms over the past week with all items on a "0" (not at all) to "3"(nearly every day) scale. Total scores range from 0 to 21; higher scores reflect greater levels of anxiety.
Time Frame
10 week study period
Title
Change in Adaptive Behavior Assessment System - 3 (ABAS-3)
Description
The ABAS-3 is a measure of adaptive function that yields age-standardized scores for three domains (Conceptual, Social and Practical) and an overall Global Adaptive Composite. Each domain and the overall General Adaptive Composite result in a standard score, with a mean of 100 and a standard deviation of 15 (scores between 86 and 114 are considered "Average" on this instrument; scores under 70 are classified as "Extremely Low" relative to same aged peers). Each domain is composed of several subdomains that yield scaled scale scores (Mean=10, SD=3), with scores between 7 and 13 falling in the "Average" range.
Time Frame
10 week study period
Title
Change in Behavioral Activation for Depression Scale
Description
The BADS is a 25-item measure designed to assess how clients become activated over the course of Behavior Activation treatment. There are 25 questions, each rated on a seven point scale ranging from 0 to 6. There are four subscales: AC = Activation subscale [score range 0 to 42] AR = Avoidance/Rumination subscale [score range 0-48] WS = Work/School Impairment subscale [score range 0-30] SI = Social Impairment subscale [score range 0-30] Higher scores indicate a better outcome on the Activation subscale. Higher scores indicate a worse outcome on the Avoidance/Rumination subscale, Work/School Impairment subscale, and Social Impairment subscale.
Time Frame
10 week study period; 4 week post-treatment
Title
Change in Idiographic target goals
Description
Clients are asked to identify 3 goals they would like to accomplish. There are no scores or scales. Each goal is a statement shared by the client relevant to their own experiences. Target goals are sensitive to change in treatment contexts.
Time Frame
10 week study period; 4 week post-treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Be 18-40 years old Have a confirmed diagnosis of Autism Spectrum Disorders (ASD). Have access to a device (e.g., computer with a webcam or smartphone) in order to complete online surveys and participate in the telehealth videoconferencing sessions *Have a VIQ and NVIQ of 85 or above *Have at least a 6th grade reading composite *Have elevated symptoms of depression, anxiety or anger. This will be determined based on scoring above the borderline or mild threshold on at least one of 3 screening measures (MINI; ASR; DASS-21). Exclusion Criteria: Are younger than 18 years old, or older than 40 years old (Children are excluded because the focus is on adapting GBAT for adults; Individuals above 40 are excluded to restrict the adult focus to young adults that are more likely to be in similar life stages). Do not have an ASD diagnosis (because the study as the purpose of the current research is to examine GBAT's feasibility with autistic adults). Both VIQ and NVIQ below 85 OR less than 6th grade reading level Do not have elevated scores of depression, anxiety, or anger on the symptom screening measures. Are unable to understand English fluently (because the instruments being investigated are currently only validated in English and the intervention will be delivered in English). Are currently enrolled in another behavioral therapy or psychotherapy targeting depression, the PI's clinical judgment that it would not be in the adult's best interest to be enrolled (e.g., due to factors that may affect their engagement or comfort in the group).
Facility Information:
Facility Name
Rutgers University
City
Piscataway
State/Province
New Jersey
ZIP/Postal Code
08854
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Transdiagnostic Group Behavioral Activation for Autistic Adults

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