Substance UsePATTNCT06538922
Developing a Digital Intervention to Prevent Risky Health Behaviors
A study testing Single Session Family Intervention in people with Substance Use, run by University of Vermont at 1 site in United States.
Trial summary
The project will launch the development of Parents and Teens Together (PATT), a dyadic digital parent-teen prevention intervention, for families of young teens experimenting or at high risk for experimenting with substance use (SU) that can provide personalized support for learning and practicing evidence-based family… Read more about this study
- Who is it for?
- Ages 12 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Substance Use
- What is being tested?
- Single Session Family Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jul 2024to 5 Dec 2024
- 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 12 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Teen participant is aged 12-14 years old
- At least one risk/behavior: Teen reports experimenting with substance (alcohol, tobacco, or marijuana) use once or twice, in the past year; a history of substance use disorder in teen's immediate family; Teen's close family, whom they have regular contact with, such as siblings or other caregivers, currently use (in past 12 months) substances; teen reports close friends experimented with tobacco, alcohol, or marijuana?
- Teen and parent participant are able to complete study activities in English
- Teen and parent participant have access to broadband or cellular internet for study activities
Who cannot join
- Teen participant is a ward of the state
- Teen diagnosis of a substance use disorder
- Parent or teen active psychosis, or severe medical or psychiatric illness that would limit ability to participate in study activities
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Parents and Teens Together (PATT): A Dyadic Digital Intervention to Prevent Substance Use Disorders
The project will launch the development of Parents and Teens Together (PATT), a dyadic digital parent-teen prevention intervention, for families of young teens experimenting or at high risk for experimenting with substance use (SU) that can provide personalized support for learning and practicing evidence-based family skills. This scalable intervention will combine a blended, virtual and health coach-led, single-session intervention (SSI) for evidence-based family skills with an mHealth app delivering a just-in-time adaptive intervention (JITAI) to support the use of family skills in daily life. As a first step in the iterative design of PATT, this project will test the acceptability, feasibility and costs of the SSI and engage in a participatory design process to finalize the plan for an initial JITAI prototype. For young teens experimenting or at risk for experimenting with SU and their parents, ready access to a scalable prevention program that closely mirrors and extends the in-time support provided in behavioral family therapy is essential for SUD prevention.
Read the detailed description
Young teens that experiment with alcohol, cannabis, or tobacco use before age 15 are 4x to 6x more likely to experience a substance use disorder (SUD). Early substance use (SU) is a detectable early danger sign for SUDs and is ideally responded to via indicated prevention intervention, which provides individualized support for youth with signs foreshadowing a SUD. The best practice indicated prevention for SUD in young teens that experiment with SU is behavioral family therapy. Behavioral family therapy shapes the development of family management skills including parental monitoring and family communication for problem-solving, relationship building, and talking about SU, via extensive supported practice. Unfortunately, families of young teens that experiment with or at high risk for experimenting with SU are unable to readily access behavioral family therapy for indicated prevention. In this project, we are launching the development of Parents and Teens Together (PATT), a dyadic digital parent-teen intervention to bridge this accessibility gap. PATT will leverage a blended, virtual and health coach-led, single session intervention (SSI) and just-in-time adaptive intervention (JITAI) technology to scale-up access to personalized instruction and support for young teens at high risk for or experimenting with SU and their parents.
This project will follow an open trial and mixed methods design. Participants will be 15 young teens, 12 to 14 years of age, who meet a high risk factor for or are experimenting with SU and their primary caregivers. The study has two primary aims. First, the investigators will assess the acceptability, feasibility, and costs of an SSI for evidence-based family skills training. Parent-teen dyads will complete a 2-hour SSI delivered virtually by a health coach that provides consultation on using evidence-based family skills. The investigators will examine participant engagement, program feedback, and costs of training and supervision for each parent-teen dyad.
Second, using a participatory design process, the investigators will conduct needs assessments to guide JITAI app design and develop a JITAI prototype. At the end of the SSI, the dyads will be asked to practice evidence-based family skills for one week. Dyads will report via a weeklong daily diary on the frequency and quality of their interactions when engaging in those skills. Then, dyads will complete a semi-structured interview. The investigators will assess daily diaries and semi-structured interviews to identify support needs and desired functions for the JITAI.
- Conditions
- Substance Use
- Being tested
- Single Session Family Intervention
- Keywords
- adolescents, evidence-based family skills training, just-in-time adaptive intervention
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single Session Family InterventionBehavioural
A health coach will deliver a 2-hour single-session consultation to support parent-teen dyadis in applying evidence-based family skills in daily life. Participants will then practice daily on their own for the next 7 days.
| Study group | Role | What they receive |
|---|---|---|
| Single Session Family Intervention | Experimental | Participants will complete a single session consultation intervention delivered remotely to provide family with feedback on using evidence-based family practices in daily life. Receives: Behavioral: Single Session Family Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of the single session intervention
Acceptability will be assessed by examining (1) single item mean scores and overall mean scores on the Program Feedback Scale, a scale used to evaluate acceptability and perceptions of SSIs, across participants. Higher scores indicated greater acceptability, range 1-5.
Measured: 2 hours (end of single session intervention)
Feasibility of the single session intervention
Feasibility will be assessed by examining the percent of full session completers.
Measured: 2 hours (end of single session intervention)
Parenting self-efficacy
average within-parent changes in key aspects of self-efficacy for parenting related to emotion and communication and evidence-based family practice with means on 10 items from the Self-Efficacy for Parenting Adolescents Scale; range 0 to 100; higher scores greater self-efficacy.
Measured: 3 Hours (before and after the single session)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2024
- Study start29 Jul 2024
- Primary completion5 Dec 2024
- Study completion5 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Substance UseStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Fifteen adolescents (aged 12-14) who are at high risk for or experimenting with substance use and their primary caregivers will complete a single appointment involving a baseline assessment, 2-hour single session evidence-based family skills training intervention, and follow-up assessment, followed by a weeklong daily diary, and semi-structured interview to guide the development of an mHealth app delivering a just-in-time adaptive intervention (JITAI).
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Vermont
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amy Hughes Lansing, University of Vermont
- Investigators
- Amy Hughes Lansing, PhD, Principal investigator, University of Vermont
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06538922
- Sponsor's protocol ID
- STUDY00002706
- Acronym
- PATT
- Status last verified
- Dec 2024
- First submitted
- 29 Jul 2024
- Last updated
- 10 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Overall analyses and de-identified data can be shared as described in participant consent, however, individual participant data will not be shared.
Publications
Lynskey MT, Heath AC, Bucholz KK, Slutske WS, Madden PA, Nelson EC, Statham DJ, Martin NG. Escalation of drug use in early-onset cannabis users vs co-twin controls. JAMA. 2003 Jan 22-29;289(4):427-33. doi: 10.1001/jama.289.4.427.
PubMed 12533121Dawson DA, Goldstein RB, Chou SP, Ruan WJ, Grant BF. Age at first drink and the first incidence of adult-onset DSM-IV alcohol use disorders. Alcohol Clin Exp Res. 2008 Dec;32(12):2149-60. doi: 10.1111/j.1530-0277.2008.00806.x. Epub 2008 Sep 30.
PubMed 18828796Strashny A. Age of Substance Use Initiation Among Treatment Admissions Aged 18 to 30. 2014 Jul 17. In: The CBHSQ Report. Rockville (MD): Substance Abuse and Mental Health Services Administration (US); 2013-. Available from http://www.ncbi.nlm.nih.gov/books/NBK384841/
PubMed 27631064Grant BF. Age at smoking onset and its association with alcohol consumption and DSM-IV alcohol abuse and dependence: results from the National Longitudinal Alcohol Epidemiologic Survey. J Subst Abuse. 1998;10(1):59-73. doi: 10.1016/s0899-3289(99)80141-2.
PubMed 9720007Anthony JC, Petronis KR. Early-onset drug use and risk of later drug problems. Drug Alcohol Depend. 1995 Nov;40(1):9-15. doi: 10.1016/0376-8716(95)01194-3.
PubMed 8746919King KM, Chassin L. A prospective study of the effects of age of initiation of alcohol and drug use on young adult substance dependence. J Stud Alcohol Drugs. 2007 Mar;68(2):256-65. doi: 10.15288/jsad.2007.68.256.
PubMed 17286344Guttmannova K, Bailey JA, Hill KG, Lee JO, Hawkins JD, Woods ML, Catalano RF. Sensitive periods for adolescent alcohol use initiation: predicting the lifetime occurrence and chronicity of alcohol problems in adulthood. J Stud Alcohol Drugs. 2011 Mar;72(2):221-31. doi: 10.15288/jsad.2011.72.221.
PubMed 21388595Wittchen HU, Behrendt S, Hofler M, Perkonigg A, Lieb R, Buhringer G, Beesdo K. What are the high risk periods for incident substance use and transitions to abuse and dependence? Implications for early intervention and prevention. Int J Methods Psychiatr Res. 2008 Jun;17 Suppl 1(Suppl 1):S16-29. doi: 10.1002/mpr.254.
PubMed 18543359Camenga DR, Hammer LD; Committee on Substance Use and Prevention, and Committee on Child Health Financing. Improving Substance Use Prevention, Assessment, and Treatment Financing to Enhance Equity and Improve Outcomes Among Children, Adolescents, and Young Adults. Pediatrics. 2022 Jul 1;150(1):e2022057992. doi: 10.1542/peds.2022-057992.
PubMed 35757960Griffin KW, Botvin GJ. Evidence-based interventions for preventing substance use disorders in adolescents. Child Adolesc Psychiatr Clin N Am. 2010 Jul;19(3):505-26. doi: 10.1016/j.chc.2010.03.005.
PubMed 20682218Ladis, B. A., Macgowan, M., Thomlison, B., Fava, N. M., Huang, H., Trucco, E. M., & Martinez, M. J. (2019). Parent-focused preventive interventions for youth substance use and problem behaviors: A systematic review. Research on Social Work Practice, 29(4), 420-442. https://doi.org/10.1177/1049731517753686
Dishion, T. J., Nelson, S. E., & Kavanagh, K. (2003). The family check-up with high-risk young adolescents: Preventing early-onset substance use by parent monitoring. Behavior Therapy, 34, 553-571.
Veronneau MH, Dishion TJ, Connell AM, Kavanagh K. A randomized, controlled trial of the family check-up model in public secondary schools: Examining links between parent engagement and substance use progressions from early adolescence to adulthood. J Consult Clin Psychol. 2016 Jun;84(6):526-43. doi: 10.1037/a0040248. Epub 2016 Apr 7.
PubMed 27054823Van Ryzin MJ, Stormshak EA, Dishion TJ. Engaging parents in the family check-up in middle school: longitudinal effects on family conflict and problem behavior through the high school transition. J Adolesc Health. 2012 Jun;50(6):627-33. doi: 10.1016/j.jadohealth.2011.10.255. Epub 2012 Jan 16.
PubMed 22626491Stormshak EA, Connell AM, Veronneau MH, Myers MW, Dishion TJ, Kavanagh K, Caruthers AS. An ecological approach to promoting early adolescent mental health and social adaptation: family-centered intervention in public middle schools. Child Dev. 2011 Jan-Feb;82(1):209-25. doi: 10.1111/j.1467-8624.2010.01551.x.
PubMed 21291438
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parents and Teens Together (PATT): A Dyadic Digital Intervention to Prevent Substance Use Disorders
- ClinicalTrials.gov ID
- NCT06538922
- Acronym / sponsor ID
- PATT / STUDY00002706
- Conditions
- Substance Use
- Keywords
- adolescents, evidence-based family skills training, just-in-time adaptive intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of VermontUniversity, hospital or other
- Study start
- 29 Jul 2024 (actual)
- Primary completion
- 5 Dec 2024 (actual)
- Study completion
- 5 Dec 2024 (actual)
- First posted
- 6 Aug 2024 (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 project will launch the development of Parents and Teens Together (PATT), a dyadic digital parent-teen prevention intervention, for families of young teens experimenting or at high risk for experimenting with substance use (SU) that can provide personalized support for learning and practicing evidence-based family skills. This scalable intervention will combine a blended, virtual and health coach-led, single-session intervention (SSI) for evidence-based family skills with an mHealth app delivering a just-in-time adaptive intervention (JITAI) to support the use of family skills in daily life. As a first step in the iterative design of PATT, this project will test the acceptability, feasibility and costs of the SSI and engage in a participatory design process to finalize the plan for an initial JITAI prototype. For young teens experimenting or at risk for experimenting with SU and their parents, ready access to a scalable prevention program that closely mirrors and extends the in-time support provided in behavioral family therapy is essential for SUD prevention.
Detailed description
Young teens that experiment with alcohol, cannabis, or tobacco use before age 15 are 4x to 6x more likely to experience a substance use disorder (SUD). Early substance use (SU) is a detectable early danger sign for SUDs and is ideally responded to via indicated prevention intervention, which provides individualized support for youth with signs foreshadowing a SUD. The best practice indicated prevention for SUD in young teens that experiment with SU is behavioral family therapy. Behavioral family therapy shapes the development of family management skills including parental monitoring and family communication for problem-solving, relationship building, and talking about SU, via extensive supported practice. Unfortunately, families of young teens that experiment with or at high risk for experimenting with SU are unable to readily access behavioral family therapy for indicated prevention. In this project, we are launching the development of Parents and Teens Together (PATT), a dyadic digital parent-teen intervention to bridge this accessibility gap. PATT will leverage a blended, virtual and health coach-led, single session intervention (SSI) and just-in-time adaptive intervention (JITAI) technology to scale-up access to personalized instruction and support for young teens at high risk for or experimenting with SU and their parents.
This project will follow an open trial and mixed methods design. Participants will be 15 young teens, 12 to 14 years of age, who meet a high risk factor for or are experimenting with SU and their primary caregivers. The study has two primary aims. First, the investigators will assess the acceptability, feasibility, and costs of an SSI for evidence-based family skills training. Parent-teen dyads will complete a 2-hour SSI delivered virtually by a health coach that provides consultation on using evidence-based family skills. The investigators will examine participant engagement, program feedback, and costs of training and supervision for each parent-teen dyad.
Second, using a participatory design process, the investigators will conduct needs assessments to guide JITAI app design and develop a JITAI prototype. At the end of the SSI, the dyads will be asked to practice evidence-based family skills for one week. Dyads will report via a weeklong daily diary on the frequency and quality of their interactions when engaging in those skills. Then, dyads will complete a semi-structured interview. The investigators will assess daily diaries and semi-structured interviews to identify support needs and desired functions for the JITAI.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Fifteen adolescents (aged 12-14) who are at high risk for or experimenting with substance use and their primary caregivers will complete a single appointment involving a baseline assessment, 2-hour single session evidence-based family skills training intervention, and follow-up assessment, followed by a weeklong daily diary, and semi-structured interview to guide the development of an mHealth app delivering a just-in-time adaptive intervention (JITAI).
| Arm | Type | Receives |
|---|---|---|
| Single Session Family Intervention | Experimental | Behavioral: Single Session Family InterventionParticipants will complete a single session consultation intervention delivered remotely to provide family with feedback on using evidence-based family practices in daily life. |
Who may qualify
- Ages
- 12 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Teen participant is aged 12-14 years old
- At least one risk/behavior: Teen reports experimenting with substance (alcohol, tobacco, or marijuana) use once or twice, in the past year; a history of substance use disorder in teen's immediate family; Teen's close family, whom they have regular contact with, such as siblings or other caregivers, currently use (in past 12 months) substances; teen reports close friends experimented with tobacco, alcohol, or marijuana?
- Teen and parent participant are able to complete study activities in English
- Teen and parent participant have access to broadband or cellular internet for study activities
Key exclusion criteria (3 listed)
- Teen participant is a ward of the state
- Teen diagnosis of a substance use disorder
- Parent or teen active psychosis, or severe medical or psychiatric illness that would limit ability to participate in study activities
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 |
|---|---|---|
| Single Session Family InterventionA health coach will deliver a 2-hour single-session consultation to support parent-teen dyadis in applying evidence-based family skills in daily life. Participants will then practice daily on their own for the next 7 days. | Behavioural | Single Session Family Intervention |
Primary outcome
Acceptability of the single session intervention
Time frame: 2 hours (end of single session intervention)
Acceptability will be assessed by examining (1) single item mean scores and overall mean scores on the Program Feedback Scale, a scale used to evaluate acceptability and perceptions of SSIs, across participants. Higher scores indicated greater acceptability, range 1-5.
Feasibility of the single session intervention
Time frame: 2 hours (end of single session intervention)
Feasibility will be assessed by examining the percent of full session completers.
Parenting self-efficacy
Time frame: 3 Hours (before and after the single session)
average within-parent changes in key aspects of self-efficacy for parenting related to emotion and communication and evidence-based family practice with means on 10 items from the Self-Efficacy for Parenting Adolescents Scale; range 0 to 100; higher scores greater self-efficacy.
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 10 Dec 2024.
- Background: PubMed 12533121Lynskey MT, Heath AC, Bucholz KK, Slutske WS, Madden PA, Nelson EC, Statham DJ, Martin NG. Escalation of drug use in early-onset cannabis users vs co-twin controls. JAMA. 2003 Jan 22-29;289(4):427-33. doi: 10.1001/jama.289.4.427.
- Background: PubMed 18828796Dawson DA, Goldstein RB, Chou SP, Ruan WJ, Grant BF. Age at first drink and the first incidence of adult-onset DSM-IV alcohol use disorders. Alcohol Clin Exp Res. 2008 Dec;32(12):2149-60. doi: 10.1111/j.1530-0277.2008.00806.x. Epub 2008 Sep 30.
- Background: PubMed 27631064Strashny A. Age of Substance Use Initiation Among Treatment Admissions Aged 18 to 30. 2014 Jul 17. In: The CBHSQ Report. Rockville (MD): Substance Abuse and Mental Health Services Administration (US); 2013-. Available from http://www.ncbi.nlm.nih.gov/books/NBK384841/
- Background: PubMed 9720007Grant BF. Age at smoking onset and its association with alcohol consumption and DSM-IV alcohol abuse and dependence: results from the National Longitudinal Alcohol Epidemiologic Survey. J Subst Abuse. 1998;10(1):59-73. doi: 10.1016/s0899-3289(99)80141-2.
- Background: PubMed 8746919Anthony JC, Petronis KR. Early-onset drug use and risk of later drug problems. Drug Alcohol Depend. 1995 Nov;40(1):9-15. doi: 10.1016/0376-8716(95)01194-3.
- Background: PubMed 17286344King KM, Chassin L. A prospective study of the effects of age of initiation of alcohol and drug use on young adult substance dependence. J Stud Alcohol Drugs. 2007 Mar;68(2):256-65. doi: 10.15288/jsad.2007.68.256.
- Background: PubMed 21388595Guttmannova K, Bailey JA, Hill KG, Lee JO, Hawkins JD, Woods ML, Catalano RF. Sensitive periods for adolescent alcohol use initiation: predicting the lifetime occurrence and chronicity of alcohol problems in adulthood. J Stud Alcohol Drugs. 2011 Mar;72(2):221-31. doi: 10.15288/jsad.2011.72.221.
- Background: PubMed 18543359Wittchen HU, Behrendt S, Hofler M, Perkonigg A, Lieb R, Buhringer G, Beesdo K. What are the high risk periods for incident substance use and transitions to abuse and dependence? Implications for early intervention and prevention. Int J Methods Psychiatr Res. 2008 Jun;17 Suppl 1(Suppl 1):S16-29. doi: 10.1002/mpr.254.
- Background: PubMed 35757960Camenga DR, Hammer LD; Committee on Substance Use and Prevention, and Committee on Child Health Financing. Improving Substance Use Prevention, Assessment, and Treatment Financing to Enhance Equity and Improve Outcomes Among Children, Adolescents, and Young Adults. Pediatrics. 2022 Jul 1;150(1):e2022057992. doi: 10.1542/peds.2022-057992.
- Background: PubMed 20682218Griffin KW, Botvin GJ. Evidence-based interventions for preventing substance use disorders in adolescents. Child Adolesc Psychiatr Clin N Am. 2010 Jul;19(3):505-26. doi: 10.1016/j.chc.2010.03.005.
- BackgroundLadis, B. A., Macgowan, M., Thomlison, B., Fava, N. M., Huang, H., Trucco, E. M., & Martinez, M. J. (2019). Parent-focused preventive interventions for youth substance use and problem behaviors: A systematic review. Research on Social Work Practice, 29(4), 420-442. https://doi.org/10.1177/1049731517753686
- BackgroundDishion, T. J., Nelson, S. E., & Kavanagh, K. (2003). The family check-up with high-risk young adolescents: Preventing early-onset substance use by parent monitoring. Behavior Therapy, 34, 553-571.
- Individual participant dataSharing planned: No. Overall analyses and de-identified data can be shared as described in participant consent, however, individual participant data will not be shared.
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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.
Amy Hughes Lansing, PhD principal investigator
University of Vermont
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single Session Family Intervention in people with Substance Use, run by University of Vermont 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: finished, as of the sponsor's last update on 10 Dec 2024. 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?
Acceptability of the single session intervention (time frame: 2 hours (end of single session intervention)). The study lists 3 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 NCT06538922, which also lists 16 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 10 Dec 2024.