Transdiagnostic Group Behavioral Activation for Autistic Adults (GBAT)
3 augusti 2021 uppdaterad av: Vanessa H. Bal, PhD, Rutgers, The State University of New Jersey
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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
6
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
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New Jersey
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Piscataway, New Jersey, Förenta staterna, 08854
- Rutgers University
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-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 40 år (Vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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).
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: GBAT
10-week behavioral activation treatment group.
|
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.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in symptoms on the Adult Self Report (ASR)
Tidsram: 10 week study period; 4 week post-treatment
|
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.
|
10 week study period; 4 week post-treatment
|
|
Change in Clinician Global Impairment rating
Tidsram: 10 week study period;
|
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.
|
10 week study period;
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in symptoms on the Depression Anxiety Stress Scales-21
Tidsram: 10 week study period; 4 week post-treatment
|
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.
|
10 week study period; 4 week post-treatment
|
|
Change in distress on Patient Health Questionnaire (PHQ-9)
Tidsram: 10 week study period
|
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.
|
10 week study period
|
|
Change in anxiety symptoms on the Generalized Anxiety Disorder Questionnaire (GAD-7)
Tidsram: 10 week study period
|
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.
|
10 week study period
|
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Change in Adaptive Behavior Assessment System - 3 (ABAS-3)
Tidsram: 10 week study period
|
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.
|
10 week study period
|
|
Change in Behavioral Activation for Depression Scale
Tidsram: 10 week study period; 4 week post-treatment
|
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. |
10 week study period; 4 week post-treatment
|
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Change in Idiographic target goals
Tidsram: 10 week study period; 4 week post-treatment
|
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.
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10 week study period; 4 week post-treatment
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Samarbetspartners och utredare
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Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
16 februari 2021
Primärt slutförande (Faktisk)
8 juli 2021
Avslutad studie (Faktisk)
8 juli 2021
Studieregistreringsdatum
Först inskickad
4 mars 2021
Först inskickad som uppfyllde QC-kriterierna
4 mars 2021
Första postat (Faktisk)
9 mars 2021
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
5 augusti 2021
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
3 augusti 2021
Senast verifierad
1 augusti 2021
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- Pro2020001634
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