Autism Spectrum DisorderNCT05030610
Adaptation of a Behavioral Activation Treatment to Treat Depression in Autistic Adults
A study testing BeatIt-ASD in people with Autism Spectrum Disorder and Depression, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial summary
The present study aims to adapt and evaluate the feasibility of the BeatIt behavioral activation intervention for people with intellectual disabilities and low mood to be implemented with autistic individuals, with and without intellectual disabilities. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Autism Spectrum Disorder, Depression, Depressive Symptoms
- What is being tested?
- BeatIt-ASD
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Aug 2021to 7 Dec 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have a confirmed diagnosis of Autism Spectrum Disorders (ASD)
- Have a best estimate diagnosis of clinically significant depressive symptoms by the study team. This will be based on DSM-5 criteria or DM-ID (Diagnostic Manual - Intellectual Disability).
- Have a support person willing to participate
- Live in New Jersey or New York, or be within travel distance to Rutgers University
- Half of participants will have a best estimate diagnosis of mild to moderate intellectual disability and half will not have intellectual disability. This will be based on participant cognitive assessment and self and/or supporter report of adaptive function during the Baseline visit.
Who cannot join
- Are unable to speak and understand English fluently (because the instruments being investigated are currently only validated in English and the focus group and intervention will be delivered in English).
- Are currently enrolled in another behavioral therapy or psychotherapy targeting depression. Participants will not be excluded if they are currently taking medication.
Trial locations and contacts
1 site in 1 country.
United States1 site
Rutgers University - New Brunswick
Piscataway, New Jersey, 08854
About this study
Official title: Treating Depression in Autistic Adults: A Feasibility Trial of an Adapted Behavioral Activation Program
The present study aims to adapt and evaluate the feasibility of the BeatIt behavioral activation intervention for people with intellectual disabilities and low mood to be implemented with autistic individuals, with and without intellectual disabilities.
Read the detailed description
The study has two specific aims:
- Adapt BeatIt materials for use with autistic adults with and without Intellectual Disability (ID). Focus groups engaging key stakeholders will inform the adaptation of BeatIt for autistic adults (i.e., BeatIt-ASD). A stakeholder advisory team will provide input through the duration of the study.
- Evaluate the feasibility, acceptability, and preliminary efficacy of BeatIt-ASD for autistic adults. This includes examining if the data demonstrate the feasibility and acceptability of the BeatIt-ASD program for autistic adults and provide preliminary evidence for behavioral change (i.e., increased engagement in meaningful activities and reduced depressive symptoms).
Data will demonstrate the feasibility and acceptability of the adapted BeatIt intervention for autistic adults and provide preliminary evidence for reduction of depression symptoms via regulation of routines and achievement of meaningful goals.
- Conditions
- Autism Spectrum Disorder, Depression, Depressive Symptoms
- Being tested
- BeatIt-ASD
- Keywords
- behavioral activation
- Medical subject headings
- Autism Spectrum Disorder, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BeatIt-ASDBehavioural
BeatIt-ASD, designed to be implemented with autistic individuals, is an adaptation of BeatIt. The intervention aims to improve mood and decrease depressive symptoms through an increase in meaningful engagement in recreational, domestic, and social/leisure activities.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Participants, along with a support person, will complete 12 weekly sessions of the BeatIt-ASD intervention. The support person will complete an initial session before commencement of the 12 weekly sessions. Receives: Behavioral: BeatIt-ASD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in distress on Patient Health Questionnaire (PHQ-9)
The PHQ-9 is a 9-item self-reported questionnaire of psychological function over the past week with all items on a "0" (not at all) to "3" (nearly every day) scale. Higher scores equal more distress. The PHQ-9 is administered to those without intellectual disability.
Measured: Week 1 (initial assessment) to week 16 (outcome) to week 22 (follow-up)
Change in distress on Glasgow Depression Scale (GDS)
The GDS is a 20-item self- and caregiver-reported questionnaire of psychological function over the past week with all items on a "0" (Never/No) to 2 (Always/A lot) scale. Higher scores equal more distress. The GDS is administered to those with intellectual disability.
Measured: Week 1 (initial assessment) to week 16 (outcome) to week 22 (follow-up)
Change in distress on Anxiety Depression and Mood Scale (ADAMS)
The ADAMS is a 20-item caregiver-reported questionnaire of psychological function over the past week with all items on a "0" (Never/No) to 2 (Always/A lot) scale. Higher scores equal more distress. The ADAMS is administered to those with intellectual disability.
Measured: Week 1 (initial assessment) to week 16 (outcome) to week 22 (follow-up)
Change on Adult Behavior Checklist (ABCL)
The ABCL is a caregiver-report measure of adaptive functioning and 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. Higher scores equal more symptoms.
Measured: Week 1 (initial assessment) to week 16 (outcome) to week 22 (follow-up)
Change on Adult Self Report (ASR)
The ASR is a self-reported measure of adaptive functioning and 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. Higher scores equal more symptoms.
Measured: Week 1 (initial assessment) to week 16 (outcome) to week 22 (follow-up)
Change in frequency of activities on Index of Community Involvement (ICI)
The ICI is a 48-item self- and caregiver-reported measure of community involvement over the previous month. All items on the measure ask the frequency of participating in activity from 0 (Never) to 5 (Daily).
Measured: Week 1 (initial assessment) to week 16 (outcome) to week 22 (follow-up)
Change in frequency of activities on Index of Participation in Domestic Life (IPDL)
The IPDL is an 18-item self- and caregiver-reported measure of participation in domestic activities over the previous month. All items on the measure ask in what manner a participant completed domestic activities from 0 (Did alone without prompting) to 2 (Did not do).
Measured: Week 1 (initial assessment) to week 16 (outcome) to week 22 (follow-up)
Change in behavioral activation on Behavioral Activation for Depression Scale (BADS)
The BADS is a 25-item self-reported measure of behaviors and thoughts related to depression. All items on the measure ask the participant to rate how much each statement describes them from 0 (not at all) to 6.
Measured: Week 1 (initial assessment) to week 16 (outcome) to week 22 (follow-up)
Secondary outcomes (2)
Change in adaptive behavior on Vineland Adaptive Behavior Scale, 3rd edition (VABS-3)
The VABS-3 is a 381-item caregiver-reported measure of adaptive behavior. All items in the measure ask the frequency at which the participants performs a behavior, from 0 (never) to 2 (usually).
Measured: Week 1 (initial assessment) to week 16 (outcome) to week 22 (follow-up)
Change in quality of life on Shalock Quality of Life Questionnaire
The Shalock Quality of Life Questionnaire is a 40-item self- and caregiver-reported measure of quality of life. Each question prompts the informant to choose one of three options (differing by item) based on which seems most appropriate to them.
Measured: Week 1 (initial assessment) to week 16 (outcome) to week 22 (follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2021
- Study start25 Aug 2021
- Primary completion7 Dec 2022
- Study completion7 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- Governor's Council for Medical Research and Treatment of Autism
- Responsible party
- Principal investigator, Vanessa H. Bal, PhD, Rutgers, The State University of New Jersey
- Investigators
- Vanessa H Bal, PhD, Principal investigator, Rutgers University - New Brunswick
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05030610
- Sponsor's protocol ID
- Pro2021001254
- Status last verified
- Mar 2023
- First submitted
- 26 Aug 2021
- Last updated
- 3 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treating Depression in Autistic Adults: A Feasibility Trial of an Adapted Behavioral Activation Program
- ClinicalTrials.gov ID
- NCT05030610
- Acronym / sponsor ID
- Pro2021001254
- Conditions
- Autism Spectrum Disorder, Depression, Depressive Symptoms
- Keywords
- behavioral activation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Collaborators
- Governor's Council for Medical Research and Treatment of Autism
- Study start
- 25 Aug 2021 (actual)
- Primary completion
- 7 Dec 2022 (actual)
- Study completion
- 7 Dec 2022 (actual)
- First posted
- 1 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The present study aims to adapt and evaluate the feasibility of the BeatIt behavioral activation intervention for people with intellectual disabilities and low mood to be implemented with autistic individuals, with and without intellectual disabilities.
Detailed description
The study has two specific aims:
- Adapt BeatIt materials for use with autistic adults with and without Intellectual Disability (ID). Focus groups engaging key stakeholders will inform the adaptation of BeatIt for autistic adults (i.e., BeatIt-ASD). A stakeholder advisory team will provide input through the duration of the study.
- Evaluate the feasibility, acceptability, and preliminary efficacy of BeatIt-ASD for autistic adults. This includes examining if the data demonstrate the feasibility and acceptability of the BeatIt-ASD program for autistic adults and provide preliminary evidence for behavioral change (i.e., increased engagement in meaningful activities and reduced depressive symptoms).
Data will demonstrate the feasibility and acceptability of the adapted BeatIt intervention for autistic adults and provide preliminary evidence for reduction of depression symptoms via regulation of routines and achievement of meaningful goals.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: BeatIt-ASDParticipants, along with a support person, will complete 12 weekly sessions of the BeatIt-ASD intervention. The support person will complete an initial session before commencement of the 12 weekly sessions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Have a confirmed diagnosis of Autism Spectrum Disorders (ASD)
- Have a best estimate diagnosis of clinically significant depressive symptoms by the study team. This will be based on DSM-5 criteria or DM-ID (Diagnostic Manual - Intellectual Disability).
- Have a support person willing to participate
- Live in New Jersey or New York, or be within travel distance to Rutgers University
- Half of participants will have a best estimate diagnosis of mild to moderate intellectual disability and half will not have intellectual disability. This will be based on participant cognitive assessment and self and/or supporter report of adaptive function during the Baseline visit.
Key exclusion criteria (2 listed)
- Are unable to speak and understand English fluently (because the instruments being investigated are currently only validated in English and the focus group and intervention will be delivered in English).
- Are currently enrolled in another behavioral therapy or psychotherapy targeting depression. Participants will not be excluded if they are currently taking medication.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BeatIt-ASDBeatIt-ASD, designed to be implemented with autistic individuals, is an adaptation of BeatIt. The intervention aims to improve mood and decrease depressive symptoms through an increase in meaningful engagement in recreational, domestic, and social/leisure activities. | Behavioural | Intervention Group |
Primary outcome
Change in distress on Patient Health Questionnaire (PHQ-9)
Time frame: Week 1 (initial assessment) to week 16 (outcome) to week 22 (follow-up)
The PHQ-9 is a 9-item self-reported questionnaire of psychological function over the past week with all items on a "0" (not at all) to "3" (nearly every day) scale. Higher scores equal more distress. The PHQ-9 is administered to those without intellectual disability.
Change in distress on Glasgow Depression Scale (GDS)
Time frame: Week 1 (initial assessment) to week 16 (outcome) to week 22 (follow-up)
The GDS is a 20-item self- and caregiver-reported questionnaire of psychological function over the past week with all items on a "0" (Never/No) to 2 (Always/A lot) scale. Higher scores equal more distress. The GDS is administered to those with intellectual disability.
Change in distress on Anxiety Depression and Mood Scale (ADAMS)
Time frame: Week 1 (initial assessment) to week 16 (outcome) to week 22 (follow-up)
The ADAMS is a 20-item caregiver-reported questionnaire of psychological function over the past week with all items on a "0" (Never/No) to 2 (Always/A lot) scale. Higher scores equal more distress. The ADAMS is administered to those with intellectual disability.
Change on Adult Behavior Checklist (ABCL)
Time frame: Week 1 (initial assessment) to week 16 (outcome) to week 22 (follow-up)
The ABCL is a caregiver-report measure of adaptive functioning and 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. Higher scores equal more symptoms.
Change on Adult Self Report (ASR)
Time frame: Week 1 (initial assessment) to week 16 (outcome) to week 22 (follow-up)
The ASR is a self-reported measure of adaptive functioning and 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. Higher scores equal more symptoms.
Change in frequency of activities on Index of Community Involvement (ICI)
Time frame: Week 1 (initial assessment) to week 16 (outcome) to week 22 (follow-up)
The ICI is a 48-item self- and caregiver-reported measure of community involvement over the previous month. All items on the measure ask the frequency of participating in activity from 0 (Never) to 5 (Daily).
Change in frequency of activities on Index of Participation in Domestic Life (IPDL)
Time frame: Week 1 (initial assessment) to week 16 (outcome) to week 22 (follow-up)
The IPDL is an 18-item self- and caregiver-reported measure of participation in domestic activities over the previous month. All items on the measure ask in what manner a participant completed domestic activities from 0 (Did alone without prompting) to 2 (Did not do).
Change in behavioral activation on Behavioral Activation for Depression Scale (BADS)
Time frame: Week 1 (initial assessment) to week 16 (outcome) to week 22 (follow-up)
The BADS is a 25-item self-reported measure of behaviors and thoughts related to depression. All items on the measure ask the participant to rate how much each statement describes them from 0 (not at all) to 6.
2 secondary outcomes
Change in adaptive behavior on Vineland Adaptive Behavior Scale, 3rd edition (VABS-3)
Time frame: Week 1 (initial assessment) to week 16 (outcome) to week 22 (follow-up)
Change in quality of life on Shalock Quality of Life Questionnaire
Time frame: Week 1 (initial assessment) to week 16 (outcome) to week 22 (follow-up)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vanessa H Bal, PhD principal investigator
Rutgers University - New Brunswick
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BeatIt-ASD in people with Autism Spectrum Disorder and Depression, 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 5 inclusion and 2 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 3 Apr 2023. 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 distress on Patient Health Questionnaire (PHQ-9) (time frame: Week 1 (initial assessment) to week 16 (outcome) to week 22 (follow-up)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Apr 2023.