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Completed

NCT Number: NCT04604236

Family Assessment Motivation, and Linkage Intervention (FAMLI)

The R34 study will integrate existing tools for use with JJ populations and examine the feasibility, acceptability, and preliminary efficacy of a caregiver-youth intervention aimed at increasing SU treatment initiation. The adaptive intervention incorporates three evidence-based components: 1) assessment of motivation and linkage-related barriers with personalized feedback, 2) Mapping-Enhanced Counseling (MEC) for improving readiness for change and interpersonal communication, and 3) Active Linkage (AL) for addressing logistical barriers to service initiation. Youth-caregiver dyads will be randomly assigned to receive an initial dose (2, 1-hr sessions) of either MEC or AL. After 30 days, participants will be classified as Responders (1 or more services initiated) or Non-responders (no service initiation). All participants will be randomized to one of two intervening interventions: an additional dose (2, 1-hr sessions) of the initial intervention (MEC or AL) or a different dose (2, 1-hr sessions of the other). The specific aims are to 1) integrate and adapt appropriate evidence-based intervention components as a dyadic intervention approach for JJ youth and caregivers; 2) test the feasibility, acceptability, and optimal configuration of the dyadic intervention components and the protocol used to evaluate effectiveness (including feasibility of recruitment, implementation, measurement); and 3) preliminarily explore a) whether an initial dose of MEC or AL is sufficient for promoting early initiation and engagement, b) whether an additional dose of MEC or AL or a change in dose is more effective, and c) which component sequence is most effective. Primary outcomes include youth (initiation of assessment or counseling; counseling attendance) and caregiver (attendance at assessment, first counseling, and/or family sessions) measures. Secondary outcomes include youth and caregiver attitudes (problem recognition, desire for help), normative beliefs (SU norms), perceived control (stressors and obstacles), and youth SU (self-report corroborated by UA results). The study addresses the sizeable gap in service receipt among JJ youth by addressing family engagement, and focuses on improving motivation to change, linkage to services, and treatment engagement.

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Key information

Conditions

Mapping Enhanced Counseling (MEC) Active Linkage (AL)

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Texas Christian University

Fort Worth, Texas, 76109, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • pre or post adjudicated or deferred prosecution
  • have an identified SU need within the past 12 months (confirmed by the TCU Drug Screen-5 during initial assessment)
  • speak English
  • no indication of active suicide risk
  • can identify one parent/guardian/responsible adult (caregiver) that is willing to participate who speaks Spanish or English

Treatment and study plan

Mapping Enhanced Counseling

Behavioral

Practitioner-led, collaborative discussion with the youth and their caregiver on co-creating guide maps for decision making around starting treatment and continuing substance use that can help users organize information and think through a series of steps, questions, and behavior choices. encountered when attempting to initiate substance use treatment services. MEC is a communication and decision-making approach that uses graphic visualization tools to train individuals to monitor and control their decision making, improve judgment and behavioral choices (self-regulation), and improve communication and mutual understanding.

Active Linkage

Behavioral

Practitioner-led, collaborative discussion with the youth and their caregiver on how to overcome barriers encountered when attempting to initiate substance use treatment services. Discussion focuses around the top barriers identified through assessment and identification of 1 or more treatment agency/options that fit the family's needs. Practitioner takes a more active role in addressing barriers to treatment by helping the family find ways to access resources for payment, childcare, or other needs, and actively linking them to the treatment provider (e.g., scheduling the initial appointment with family present).

Primary outcomes

  1. Youth Initiation

    Time frame: Week 4

    Youth attendance at 1 or more treatment appointment (assessment or counseling), obtained through self-report and corroborated using probation agency attendance records

  2. Youth Initiation

    Time frame: Week 9

    Youth attendance at 1 or more treatment appointment (assessment or counseling), obtained through self-report and corroborated using probation agency attendance records

  3. Youth Initiation

    Time frame: Week 17

    Youth attendance at 1 or more treatment appointment (assessment or counseling), obtained through self-report and corroborated using probation agency attendance records

  4. Caregiver attendance with youth at 1 or more treatment appointment

    Time frame: Week 4

    Caregiver attendance with youth at 1 or more treatment appointment (assessment, counseling)

  5. Caregiver attendance with youth at 1 or more treatment appointment

    Time frame: Week 9

    Caregiver attendance with youth at 1 or more treatment appointment (assessment, counseling)

  6. Caregiver attendance with youth at 1 or more treatment appointment

    Time frame: Week 17

    Caregiver attendance with youth at 1 or more treatment appointment (assessment, counseling)

Secondary outcomes

  1. Change in Youth Treatment Motivation as measured by the TCU MOT Form

    Time frame: Weeks 1, 9, and 17

    Change in motivation for treatment (problem recognition, desire for help, treatment readiness)

  2. Change in Caregiver's Perception of Youth's Treatment Motivation as measured by the TCU MOT Form

    Time frame: Weeks 1, 9, and 17

    Change in motivation for treatment (recognition of youth's drug problem, desire for help, treatment readiness)

  3. Change in Youth Normative Beliefs about Substance Use as measured by the TCU THK Form

    Time frame: Weeks 1, 9, and 17

    Change in beliefs about substance use (drug culture)

  4. Change in Caregiver Normative Beliefs about Substance Use as measured by the TCU THK Form

    Time frame: Weeks 1, 9, and 17

    Change in beliefs about substance use (drug culture)

  5. Change in Youth Perceived Control over Substance Use as measured by the TCU THK Form

    Time frame: Weeks 1, 9, and 17

    Change in perceived control over substance use

  6. Change in Youth Perceived Control over Treatment Initiation as measured by the Barriers to Treatment Participation Scale (BTPS)

    Time frame: Weeks 1, 9, and 17

    Change in perceived control over treatment initiation (number of barriers to seeking and starting treatment)

  7. Change in Caregiver Perceived Control over Youth's Substance Use as measured by the Caregiver Strain Questionnaire (CGSQ-SF7):

    Time frame: Weeks 1, 9, and 17

    Change in perceived control over youth's substance use (stressors and obstacles caused by youth's substance use)

  8. Change in Caregiver Perceived Control over Youth's Treatment Initiation as measured by the Barriers to Treatment Participation Scale (BTPS)

    Time frame: Weeks 1, 9, and 17

    Change in perceived control over youth's treatment initiation (number of barriers to seeking and starting treatment)

  9. Change in Youth Intentions to Use Substances as measured by the TCU THK Form

    Time frame: Weeks 1, 5, 9, and 17

    Change in intention to use substances (drug resistance efficacy) and to initiate treatment

  10. Change in Youth Intentions to Initiate Treatment

    Time frame: Weeks 1, 5, 9, and 17

    Change in intention to initiate treatment

  11. Change in Caregiver Intentions to schedule and attend youth's treatment sessions

    Time frame: Weeks 1, 5, 9, and 17

    Change in intention to initiate youth's substance use treatment (intention to contact agency, intention to accompany child)

  12. Change in Youth Substance Use as measured by the TCUDS and Opioid Supplement Forms

    Time frame: Weeks 1, 5, 9, and 17

    Self-reported use of substances (e.g., alcohol, marijuana, opioids), corroborated by urinalysis

  13. Change in Family relationships as measured by the TCU FFS Scale

    Time frame: Weeks 1, 9, and 17

    Change in quality of family relationships (warmth, control, conflict)

  14. Change in Family responsiveness as measured by the Family Assessment Device (FAD)

    Time frame: Weeks 1, 9, and 17

    Change in quality of family affective responsiveness, affective involvement, behavior control)

Sponsors and collaborators

Lead sponsor

Texas Christian University

Other

Registry information

Official study title

Increasing Family Engagement and Treatment Initiation Through Family Assessment, Motivation,and Linkage Intervention (FAMLI)

Acronym: FAMLI

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 27, 2020
Registry last updated
Sep 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.