AutismNCT07216196
The Feasibility of a Remote Problem-Solving Intervention for Autistic Adolescents or Young Adults and a Caregiver
A study testing Pathways and Resources for Engagement and Participation (PREP) in people with Autism, run by University of Missouri-Columbia at 1 site in United States.
Trial summary
This project seeks to evaluate the feasibility and acceptability of a remote metacognitive strategy training intervention in transition-age autistic adolescents and young adults and a primary caregiver. We will also conduct limited efficacy testing. Read more about this study
- Who is it for?
- Ages 13 to 21 years
- Conditions the study is for
- Autism
- What is being tested?
- Pathways and Resources for Engagement and Participation (PREP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Apr 2026to 3 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 13 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Autistic adolescents aged 13-21 AND one primary parent, guardian, or caregiver aged 18 or older
- At least one year remaining in high school
- Ability to engage in reciprocal conversation
- Ability to provide informed consent/assent as part of an adapted procedure designed to prevent coercion and protect the rights of autistic adolescents with or without intellectual disability
Who cannot join
- Severe or profound intellectual disability (IQ<35)
- Severe mental health conditions that interfere with ability to participate in the intervention
- Currently enrolled in community-based transition services redundant with remote PREP
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Missouri - Columbia
Columbia, Missouri, 65211
Melanie M. Tkach, PhD, 573-882-0992, melanie.tkach@health.missouri.edu
Melanie M. Tkach, PhD
About this study
Official title: The Effect of Dyadic Metacognitive Strategy Training in Autistic Youth or Young Adults and a Primary Caregiver
This project seeks to evaluate the feasibility and acceptability of a remote metacognitive strategy training intervention in transition-age autistic adolescents and young adults and a primary caregiver. We will also conduct limited efficacy testing.
Read the detailed description
The U.S. healthcare and educations systems are failing autistic adolescents and young adults (AYAs) through inadequate or inaccessible services that hinder the development of independent living skills for long-term participation, health, and the transition to adulthood. In fact, only 19% of autistic AYAs who received special education services live independently and just over half were employed by their early 20s. These trends negatively impact autistic people's health and well-being and result in substantial familial and societal costs ranging from $1.4 to $2.4 million per person. Existing rehabilitation interventions for autistic AYAs primarily target isolated skills and overlook caregiver influences on AYA outcomes, so intervention gains do not translate to improvements in long-term participation or transition outcomes.
Pathways and Resources for Engagement and Participation (PREP), an MCST intervention for AYAs with physical disabilities and their families, may improve participation, health, and transition outcomes in autistic youths. PREP is a problem-solving approach to family-chosen goals that focuses on activity or environmental modifications over skill development. PREP improves activity performance and participation in AYAs with physical disabilities and autistic children ages 6-12. However, PREP has not been rigorously tested with autistic AYAs and caregivers. The critical next step is to test whether PREP improves participation, health and well-being, and transition outcomes in autistic AYAs. The overall study hypothesis is that PREP will be feasible for autistic AYAs and caregivers.
We will conduct a randomized controlled trial with waitlist crossover in autistic AYAs and their caregivers (e.g., youth-caregiver dyads). Youth-caregiver dyads will include one autistic AYA and one primary caregiver that meet other study inclusion criteria and provide electronic informed consent and assent. AYA-caregiver dyads will complete a baseline assessment (T1) of AYA activity performance, participation, and mental health. Then, they will be randomly assigned to intervention or waitlist control groups. The intervention group will complete remote PREP immediately (one hour/week x 12 weeks), and the waitlist control group will wait 12 weeks without intervention and then complete remote PREP (one hour/week x 12 weeks). The intervention group will complete post-intervention (T2) and follow-up (T3) assessments. The waitlist control group will complete second baseline (T2) and post-intervention (T3) assessments. AYA-caregiver dyads will complete one in-depth, semi-structured interview post-intervention to determine intervention acceptability.
We aim to test the feasibility of remote PREP for autistic AYAs and their caregivers. We hypothesize that feasibility data (e.g., recruitment, retention, and intervention adherence) will indicate that the study protocol and intervention can be implemented with autistic AYAs and a primary caregiver. We also hypothesize that acceptability data will indicate adequate intervention acceptability and inform optimization for future trials. Our second aim is to conduct limited efficacy testing to identify the preliminary effect of remote PREP on AYA outcomes. We hypothesize that effect size estimations will indicate the remote PREP has a greater positive effect, compared to waitlist control, on AYA activity performance, participation, health, and transition outcomes.
- Conditions
- Autism
- Being tested
- Pathways and Resources for Engagement and Participation (PREP)
- Keywords
- Occupational Therapy, Autism, Transition to Adulthood, Waitlist Crossover
- Medical subject headings
- Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pathways and Resources for Engagement and Participation (PREP)Behavioural
Pathways and Resources for Engagement and Participation (PREP) is a collaborative problem-solving intervention that targets environmental barriers-physical, social, attitudinal, familial, and institutional-while leveraging adolescent and family strengths. Caregivers are integrated as key supports. The five-step process includes: (1) make goals, (2) map out a plan, (3) make it happen, (4) measure outcomes, and (5) move forward. We will set four activity-based transition goals using the Transition Planning Inventory-2nd Edition and Goal Attainment Scaling. Providers will use guided discovery to help adolescents and caregivers identify strategies that modify activities or environments to support participation in transition activities. Adolescents and caregivers will implement strategies between sessions and revise strategies with the provider in future sessions if unsuccessful. Participants will complete 12 weekly 60-min remote PREP sessions over 12-16 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Remote Metacognitive Strategy Training | Experimental | The intervention group will complete the remote metacognitive strategy training intervention immediately. Receives: Behavioral: Pathways and Resources for Engagement and Participation (PREP) |
| Waitlist Control | No intervention | The waitlist control group will wait 12 weeks without intervention. Then, they will crossover into the intervention arm and receive the remote metacognitive strategy training intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of Intervention Measure (AIM)
Measure of intervention acceptability. Self-report Likert scale from 1 -completely disagree to 5 - completely agree
Measured: Intervention - week 13; Waitlist control - week 25
Semi-Structured Interview
A brief interview to gather participant perceptions of the intervention, including their perceived benefit and practicality of the intervention and suggestions for improvement for the intervention. Data will be qualitative interview transcripts.
Measured: Intervention - week 13; Waitlist control - week 25
Secondary outcomes (5)
Participation and Environment Measure - Child and Youth
Caregiver proxy report measure of adolescent activity participation at home, school, and in the community. Caregivers rate adolescents' participation frequency (0 - never to 7 - daily) and involvement (1 - minimally involved to 5 - very involved). Higher scores represent better adolescent participation.
Measured: Intervention - Baseline (week 0), post-intervention (week 13), follow-up (week 25); Waitlist control- Baseline (week 0), second baseline (week 13), post-intervention (week 25)
Youth, Young Adult Participation and Environment Measure
Self-report measure of adolescent and young adult activity participation at home, school, and in the community. Adolescents and young adults rate their participation frequency (0 - never to 7 - daily) and involvement (1 - minimally involved to 5 - very involved). Higher scores represent better adolescent participation.
Measured: Intervention - Baseline (week 0), post-intervention (week 13), follow-up (week 25); Waitlist Control - Baseline (week 0), second baseline (week 13), post-intervention (week 25)
Patient-Reported Outcomes Measurement Information System Pediatric Global Health Measure 7+2
Informant and self-report questionnaire of adolescent and young adult physical and mental health. Item responses range from 1 - poor to 5 - excellent. Higher scores represent better health.
Measured: Baseline (week 0), post-intervention (week 13), follow-up (week 25); Baseline (week 0), second baseline (week 13), post-intervention (week 25)
Transition Readiness Scale
Informant and self-report measure of adolescent transition readiness (education, work, independent living). Self-report scale that ranges from 1 - not true for me/my child to 4 - true for me/my child. Higher scores represent better transition readiness.
Measured: Intervention - Baseline (week 0), post-intervention (week 13), follow-up (week 25); Waitlist Control - Baseline (week 0), second baseline (week 13), post-intervention (week 25)
Canadian Occupational Performance Measure (COPM)
Self-report measure of activity performance. Minimum = 1, Maximum = 10. Higher scores mean better performance.
Measured: Intervention - Baseline (week 0), post-intervention (week 13), follow-up (week 25); Waitlist control- Baseline (week 0), second baseline (week 13), post-intervention (week 25)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2025
- Study start8 Apr 2026
- Primary completion3 Nov 2026 (estimated)
- Study completion3 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for AutismStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melanie Tkach, University of Missouri-Columbia
- Investigators
- Melanie M. Tkach, PhD, Principal investigator, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07216196
- Sponsor's protocol ID
- 2126948
- Status last verified
- Jan 2026
- First submitted
- 9 Oct 2025
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Anderson KA, Sosnowy C, Kuo AA, Shattuck PT. Transition of Individuals With Autism to Adulthood: A Review of Qualitative Studies. Pediatrics. 2018 Apr;141(Suppl 4):S318-S327. doi: 10.1542/peds.2016-4300I.
PubMed 29610413Snell-Rood C, Ruble L, Kleinert H, McGrew JH, Adams M, Rodgers A, Odom J, Wong WH, Yu Y. Stakeholder perspectives on transition planning, implementation, and outcomes for students with autism spectrum disorder. Autism. 2020 Jul;24(5):1164-1176. doi: 10.1177/1362361319894827. Epub 2020 Jan 20.
PubMed 31957461Kang LJ, Huang HH, Wu YT, Chen CL. Initial evaluation of an environment-based intervention for participation of autistic children: a randomized controlled trial. Disabil Rehabil. 2024 May;46(9):1851-1861. doi: 10.1080/09638288.2023.2209743. Epub 2023 May 15.
PubMed 37183406Hsieh YH, Ryan M, Anaby D. Towards multi-faceted outcomes of participation-based interventions: mapping the PREP's effects for children and youth with disabilities. Disabil Rehabil. 2024 Oct;46(20):4825-4834. doi: 10.1080/09638288.2023.2280084. Epub 2023 Nov 21.
PubMed 39319861Little LM, Cohen SR, Tomchek SD, Baker A, Wallisch A, Dean E. Interventions to Support Social Participation for Autistic Children and Adolescents in Homes and Communities (2013-2021). Am J Occup Ther. 2023 Mar 1;77(Suppl 1):7710393200. doi: 10.5014/ajot.2023.77S10020.
PubMed 37611261Baker A, Tomchek SD, Little LM, Wallisch A, Dean E. Interventions to Support Participation in Basic and Instrumental Activities of Daily Living for Autistic Children and Adolescents (2013-2021). Am J Occup Ther. 2023 Mar 1;77(Suppl 1):7710393140. doi: 10.5014/ajot.2023.77S10014.
PubMed 37562056Egilson ST, Jakobsdottir G, Olafsson K, Leosdottir T. Community participation and environment of children with and without autism spectrum disorder: parent perspectives. Scand J Occup Ther. 2017 May;24(3):187-196. doi: 10.1080/11038128.2016.1198419. Epub 2016 Jun 22.
PubMed 27329683
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dyadic Metacognitive Strategy Training in Autistic Youth or Young Adults and a Primary Caregiver
- ClinicalTrials.gov ID
- NCT07216196
- Acronym / sponsor ID
- 2126948
- Conditions
- Autism
- Keywords
- Occupational Therapy, Autism, Transition to Adulthood, Waitlist Crossover
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Study start
- 8 Apr 2026 (actual)
- Primary completion
- 3 Nov 2026 (estimated)
- Study completion
- 3 May 2027 (estimated)
- First posted
- 14 Oct 2025 (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.
This project seeks to evaluate the feasibility and acceptability of a remote metacognitive strategy training intervention in transition-age autistic adolescents and young adults and a primary caregiver. We will also conduct limited efficacy testing.
Detailed description
The U.S. healthcare and educations systems are failing autistic adolescents and young adults (AYAs) through inadequate or inaccessible services that hinder the development of independent living skills for long-term participation, health, and the transition to adulthood. In fact, only 19% of autistic AYAs who received special education services live independently and just over half were employed by their early 20s. These trends negatively impact autistic people's health and well-being and result in substantial familial and societal costs ranging from $1.4 to $2.4 million per person. Existing rehabilitation interventions for autistic AYAs primarily target isolated skills and overlook caregiver influences on AYA outcomes, so intervention gains do not translate to improvements in long-term participation or transition outcomes.
Pathways and Resources for Engagement and Participation (PREP), an MCST intervention for AYAs with physical disabilities and their families, may improve participation, health, and transition outcomes in autistic youths. PREP is a problem-solving approach to family-chosen goals that focuses on activity or environmental modifications over skill development. PREP improves activity performance and participation in AYAs with physical disabilities and autistic children ages 6-12. However, PREP has not been rigorously tested with autistic AYAs and caregivers. The critical next step is to test whether PREP improves participation, health and well-being, and transition outcomes in autistic AYAs. The overall study hypothesis is that PREP will be feasible for autistic AYAs and caregivers.
We will conduct a randomized controlled trial with waitlist crossover in autistic AYAs and their caregivers (e.g., youth-caregiver dyads). Youth-caregiver dyads will include one autistic AYA and one primary caregiver that meet other study inclusion criteria and provide electronic informed consent and assent. AYA-caregiver dyads will complete a baseline assessment (T1) of AYA activity performance, participation, and mental health. Then, they will be randomly assigned to intervention or waitlist control groups. The intervention group will complete remote PREP immediately (one hour/week x 12 weeks), and the waitlist control group will wait 12 weeks without intervention and then complete remote PREP (one hour/week x 12 weeks). The intervention group will complete post-intervention (T2) and follow-up (T3) assessments. The waitlist control group will complete second baseline (T2) and post-intervention (T3) assessments. AYA-caregiver dyads will complete one in-depth, semi-structured interview post-intervention to determine intervention acceptability.
We aim to test the feasibility of remote PREP for autistic AYAs and their caregivers. We hypothesize that feasibility data (e.g., recruitment, retention, and intervention adherence) will indicate that the study protocol and intervention can be implemented with autistic AYAs and a primary caregiver. We also hypothesize that acceptability data will indicate adequate intervention acceptability and inform optimization for future trials. Our second aim is to conduct limited efficacy testing to identify the preliminary effect of remote PREP on AYA outcomes. We hypothesize that effect size estimations will indicate the remote PREP has a greater positive effect, compared to waitlist control, on AYA activity performance, participation, health, and transition outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remote Metacognitive Strategy Training | Experimental | Behavioral: Pathways and Resources for Engagement and Participation (PREP)The intervention group will complete the remote metacognitive strategy training intervention immediately. |
| Waitlist Control | No intervention | –The waitlist control group will wait 12 weeks without intervention. Then, they will crossover into the intervention arm and receive the remote metacognitive strategy training intervention. |
Who may qualify
- Ages
- 13 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Autistic adolescents aged 13-21 AND one primary parent, guardian, or caregiver aged 18 or older
- At least one year remaining in high school
- Ability to engage in reciprocal conversation
- Ability to provide informed consent/assent as part of an adapted procedure designed to prevent coercion and protect the rights of autistic adolescents with or without intellectual disability
Key exclusion criteria (3 listed)
- Severe or profound intellectual disability (IQ<35)
- Severe mental health conditions that interfere with ability to participate in the intervention
- Currently enrolled in community-based transition services redundant with remote PREP
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 |
|---|---|---|
| Pathways and Resources for Engagement and Participation (PREP)Pathways and Resources for Engagement and Participation (PREP) is a collaborative problem-solving intervention that targets environmental barriers-physical, social, attitudinal, familial, and institutional-while leveraging adolescent and family strengths. Caregivers are integrated as key supports. The five-step process includes: (1) make goals, (2) map out a plan, (3) make it happen, (4) measure outcomes, and (5) move forward. We will set four activity-based transition goals using the Transition Planning Inventory-2nd Edition and Goal Attainment Scaling. Providers will use guided discovery to help adolescents and caregivers identify strategies that modify activities or environments to support participation in transition activities. Adolescents and caregivers will implement strategies between sessions and revise strategies with the provider in future sessions if unsuccessful. Participants will complete 12 weekly 60-min remote PREP sessions over 12-16 weeks. | Behavioural | Remote Metacognitive Strategy Training |
Primary outcome
Acceptability of Intervention Measure (AIM)
Time frame: Intervention - week 13; Waitlist control - week 25
Measure of intervention acceptability. Self-report Likert scale from 1 -completely disagree to 5 - completely agree
Semi-Structured Interview
Time frame: Intervention - week 13; Waitlist control - week 25
A brief interview to gather participant perceptions of the intervention, including their perceived benefit and practicality of the intervention and suggestions for improvement for the intervention. Data will be qualitative interview transcripts.
5 secondary outcomes
Participation and Environment Measure - Child and Youth
Time frame: Intervention - Baseline (week 0), post-intervention (week 13), follow-up (week 25); Waitlist control- Baseline (week 0), second baseline (week 13), post-intervention (week 25)
Youth, Young Adult Participation and Environment Measure
Time frame: Intervention - Baseline (week 0), post-intervention (week 13), follow-up (week 25); Waitlist Control - Baseline (week 0), second baseline (week 13), post-intervention (week 25)
Patient-Reported Outcomes Measurement Information System Pediatric Global Health Measure 7+2
Time frame: Baseline (week 0), post-intervention (week 13), follow-up (week 25); Baseline (week 0), second baseline (week 13), post-intervention (week 25)
Transition Readiness Scale
Time frame: Intervention - Baseline (week 0), post-intervention (week 13), follow-up (week 25); Waitlist Control - Baseline (week 0), second baseline (week 13), post-intervention (week 25)
Canadian Occupational Performance Measure (COPM)
Time frame: Intervention - Baseline (week 0), post-intervention (week 13), follow-up (week 25); Waitlist control- Baseline (week 0), second baseline (week 13), post-intervention (week 25)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Background: PubMed 29610413Anderson KA, Sosnowy C, Kuo AA, Shattuck PT. Transition of Individuals With Autism to Adulthood: A Review of Qualitative Studies. Pediatrics. 2018 Apr;141(Suppl 4):S318-S327. doi: 10.1542/peds.2016-4300I.
- Background: PubMed 31957461Snell-Rood C, Ruble L, Kleinert H, McGrew JH, Adams M, Rodgers A, Odom J, Wong WH, Yu Y. Stakeholder perspectives on transition planning, implementation, and outcomes for students with autism spectrum disorder. Autism. 2020 Jul;24(5):1164-1176. doi: 10.1177/1362361319894827. Epub 2020 Jan 20.
- Background: PubMed 37183406Kang LJ, Huang HH, Wu YT, Chen CL. Initial evaluation of an environment-based intervention for participation of autistic children: a randomized controlled trial. Disabil Rehabil. 2024 May;46(9):1851-1861. doi: 10.1080/09638288.2023.2209743. Epub 2023 May 15.
- Background: PubMed 39319861Hsieh YH, Ryan M, Anaby D. Towards multi-faceted outcomes of participation-based interventions: mapping the PREP's effects for children and youth with disabilities. Disabil Rehabil. 2024 Oct;46(20):4825-4834. doi: 10.1080/09638288.2023.2280084. Epub 2023 Nov 21.
- Background: PubMed 37611261Little LM, Cohen SR, Tomchek SD, Baker A, Wallisch A, Dean E. Interventions to Support Social Participation for Autistic Children and Adolescents in Homes and Communities (2013-2021). Am J Occup Ther. 2023 Mar 1;77(Suppl 1):7710393200. doi: 10.5014/ajot.2023.77S10020.
- Background: PubMed 37562056Baker A, Tomchek SD, Little LM, Wallisch A, Dean E. Interventions to Support Participation in Basic and Instrumental Activities of Daily Living for Autistic Children and Adolescents (2013-2021). Am J Occup Ther. 2023 Mar 1;77(Suppl 1):7710393140. doi: 10.5014/ajot.2023.77S10014.
- Background: PubMed 27329683Egilson ST, Jakobsdottir G, Olafsson K, Leosdottir T. Community participation and environment of children with and without autism spectrum disorder: parent perspectives. Scand J Occup Ther. 2017 May;24(3):187-196. doi: 10.1080/11038128.2016.1198419. Epub 2016 Jun 22.
- PREP Intervention ProtocolLink provided by the sponsor.
- 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.
Melanie M. Tkach, PhD principal investigator
University of Missouri-Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pathways and Resources for Engagement and Participation (PREP) in people with Autism, run by University of Missouri-Columbia 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 4 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 28 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Melanie M. Tkach, PhD (573-882-0992, melanie.tkach@health.missouri.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of Intervention Measure (AIM) (time frame: Intervention - week 13; Waitlist control - week 25). 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 NCT07216196, which also lists 7 linked publications.
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 28 Apr 2026; AzTrials last refreshed its copy on 30 Oct 2026.