Family Assessment Motivation, and Linkage Intervention (FAMLI)

NCT04604236 | Completed

• 1 other identifier: 1R34DA049079-01
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mapping Enhanced Counseling (MEC); Active Linkage (AL)

Outcome Measures

Primary Outcomes (6)

• Youth Initiation

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

  Week 4

• Youth Initiation

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

  Week 9

• Youth Initiation

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

  Week 17

• Caregiver attendance with youth at 1 or more treatment appointment

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

  Week 4

• Caregiver attendance with youth at 1 or more treatment appointment

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

  Week 9

• Caregiver attendance with youth at 1 or more treatment appointment

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

  Week 17

Secondary Outcomes (14)

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

  Weeks 1, 9, and 17

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

  Weeks 1, 9, and 17

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

  Weeks 1, 9, and 17

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

  Weeks 1, 9, and 17

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

  Weeks 1, 9, and 17

Study Arms (2)

Mapping Enhanced Counseling (MEC)

EXPERIMENTAL

MEC will target attitudes and norms. Attitudes include motivation for change, such as problem recognition and a belief that treatment will help. Subjective norms include normative beliefs about SU in adolescence (e.g., belief that it is ok to allow SU with parental supervision; experimentation is normal) and expectations about treatment.

Behavioral: Mapping Enhanced Counseling

Active Linkage (AL)

EXPERIMENTAL

AL will target perceived control. Perceived control includes perceived logistical barriers and the degree to which individuals feel they can overcome them.

Behavioral: Active Linkage

Interventions

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.

Mapping Enhanced Counseling (MEC)

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).

Active Linkage (AL)

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

Sponsors & Collaborators

• Texas Christian University: lead

Study Sites (1)

Texas Christian University

Fort Worth, Texas, 76109, United States

Location

Study Officials

• Danica Knight, PhD

  Texas Christian University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 15, 2020
• First Posted: October 27, 2020
• Study Start: July 7, 2022
• Primary Completion: April 17, 2023
• Study Completion: April 17, 2023
• Last Updated: September 8, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)