Developing a Digital Intervention to Prevent Risky Health Behaviors

NCT06538922 | Completed

• 1 other identifier: STUDY00002706
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Substance Use

Keywords

adolescents; evidence-based family skills training; just-in-time adaptive intervention

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  3 Hours (before and after the single session)

Study Arms (1)

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.

Behavioral: Single Session Family Intervention

Interventions

Single Session Family Intervention BEHAVIORAL

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.

Single Session Family Intervention

Eligibility Criteria

• Age: 12 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Vermont: lead

Study Sites (1)

University of Vermont

Burlington, Vermont, 05401, United States

Location

Related Publications (15)

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  PMID: 12533121 BACKGROUND

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  PMID: 18828796 BACKGROUND

• Strashny 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/

  PMID: 27631064 BACKGROUND

• Grant 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.

  PMID: 9720007 BACKGROUND

• Anthony 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.

  PMID: 8746919 BACKGROUND

• King 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.

  PMID: 17286344 BACKGROUND

• Guttmannova 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.

  PMID: 21388595 BACKGROUND

• Wittchen 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.

  PMID: 18543359 BACKGROUND

• Camenga 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.

  PMID: 35757960 BACKGROUND

• Griffin 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.

  PMID: 20682218 BACKGROUND

• Ladis, 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

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 27054823 BACKGROUND

• Van 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.

  PMID: 22626491 BACKGROUND

• Stormshak 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.

  PMID: 21291438 BACKGROUND

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Study Officials

• Amy Hughes Lansing, PhD

  University of Vermont

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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).

Study Record Dates

• First Submitted: July 29, 2024
• First Posted: August 6, 2024
• Study Start: July 29, 2024
• Primary Completion: December 5, 2024
• Study Completion: December 5, 2024
• Last Updated: December 10, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)