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Autism Spectrum DisorderGBATNCT04788212

Transdiagnostic Group Behavioral Activation for Autistic Adults

A study testing Group Behavioral Activation Therapy for Autism Spectrum Disorder in people with Autism Spectrum Disorder and Depression, Anxiety, run by Rutgers, The State University of New Jersey at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 40 years
What is being tested?
Group Behavioral Activation Therapy for Autism Spectrum Disorder
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteUnited States
Study dates
16 Feb 2021to 8 Jul 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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).

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Rutgers University

    Piscataway, New Jersey, 08854

Other trials in United States

About this study

Official title: Adaptation of a Transdiagnostic Behavioral Activation Telehealth Group for Autistic Adults

The purpose of this study is to evaluate the feasibility, acceptability and effectiveness of a telehealth Group Behavioral Activation Therapy (GBAT) for autistic adults.

Read the 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.

Being tested
Group Behavioral Activation Therapy for Autism Spectrum Disorder
Medical subject headings
Autism Spectrum Disorder, Depression, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Group Behavioral Activation Therapy for Autism Spectrum DisorderBehavioural

    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.

Study groups in NCT04788212
Study groupRoleWhat they receive
GBATExperimental10-week behavioral activation treatment group.
Receives: Behavioral: Group Behavioral Activation Therapy for Autism Spectrum Disorder

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 10 week study period; 4 week post-treatment

  2. 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.

    Measured: 10 week study period;

Secondary outcomes (6)

  1. 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.

    Measured: 10 week study period; 4 week post-treatment

  2. 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.

    Measured: 10 week study period

  3. 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.

    Measured: 10 week study period

  4. 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.

    Measured: 10 week study period

  5. 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.

    Measured: 10 week study period; 4 week post-treatment

  6. 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.

    Measured: 10 week study period; 4 week post-treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Mar 2021
  2. Study start16 Feb 2021
  3. Primary completion8 Jul 2021
  4. Study completion8 Jul 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
8 participants with autism and depression, anxiety or anger will participate
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04788212
Sponsor's protocol ID
Pro2020001634
Acronym
GBAT
Status last verified
Aug 2021
First submitted
4 Mar 2021
Last updated
5 Aug 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Group Behavioral Activation Therapy for Autism Spectrum Disorder in people with Autism Spectrum Disorder and Depression, Anxiety, run by Rutgers, The State University of New Jersey at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in symptoms on the Adult Self Report (ASR) (time frame: 10 week study period; 4 week post-treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04788212.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2021.

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