Clinical trial NCT04788212: Transdiagnostic Group Behavioral Activation for Autistic Adults
Official title: Adaptation of a Transdiagnostic Behavioral Activation Telehealth Group for Autistic Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Depression, Anxiety
Anxiety
Anger
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
First posted: 2021-03-09
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 8 participants with autism and depression, anxiety or anger will participate
Primary purpose: TREATMENT

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Change in symptoms on the Adult Self Report (ASR)
timeFrame: 10 week study period; 4 week post-treatment
measure: Change in Clinician Global Impairment rating
timeFrame: 10 week study period;
Secondary outcomes:
measure: Change in symptoms on the Depression Anxiety Stress Scales-21
timeFrame: 10 week study period; 4 week post-treatment
measure: Change in distress on Patient Health Questionnaire (PHQ-9)
timeFrame: 10 week study period
measure: Change in anxiety symptoms on the Generalized Anxiety Disorder Questionnaire (GAD-7)
timeFrame: 10 week study period
measure: Change in Adaptive Behavior Assessment System - 3 (ABAS-3)
timeFrame: 10 week study period
measure: Change in Behavioral Activation for Depression Scale
timeFrame: 10 week study period; 4 week post-treatment
measure: Change in Idiographic target goals
timeFrame: 10 week study period; 4 week post-treatment
Other outcomes:
Locations:
city: Piscataway
country: United States
facility: Rutgers University
state: New Jersey
Study officials:
References: