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Transdiagnostic Group Behavioral Activation for Autistic Adults (GBAT)

3 augustus 2021 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

6

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • New Jersey
      • Piscataway, New Jersey, Verenigde Staten, 08854
        • Rutgers University

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 40 jaar (Volwassen)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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).

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: GBAT
10-week behavioral activation treatment group.
Gedragsmatig: Group Behavioral Activation Therapy for Autism Spectrum Disorder
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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in symptoms on the Adult Self Report (ASR)
Tijdsspanne: 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
Tijdsspanne: 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;

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in symptoms on the Depression Anxiety Stress Scales-21
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Change in Adaptive Behavior Assessment System - 3 (ABAS-3)
Tijdsspanne: 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
Tijdsspanne: 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
Change in Idiographic target goals
Tijdsspanne: 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.
10 week study period; 4 week post-treatment

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Rutgers, The State University of New Jersey

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

16 februari 2021

Primaire voltooiing (Werkelijk)

8 juli 2021

Studie voltooiing (Werkelijk)

8 juli 2021

Studieregistratiedata

Eerst ingediend

4 maart 2021

Eerst ingediend dat voldeed aan de QC-criteria

4 maart 2021

Eerst geplaatst (Werkelijk)

9 maart 2021

Updates van studierecords

Laatste update geplaatst (Werkelijk)

5 augustus 2021

Laatste update ingediend die voldeed aan QC-criteria

3 augustus 2021

Laatst geverifieerd

1 augustus 2021

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • Pro2020001634

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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