Clinical trial NCT04604236: Family Assessment Motivation, and Linkage Intervention (FAMLI)
Official title: Increasing Family Engagement and Treatment Initiation Through Family Assessment, Motivation,and Linkage Intervention (FAMLI)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mapping Enhanced Counseling (MEC)
Active Linkage (AL)
Lead sponsor: Texas Christian University
Sponsor class: OTHER
First posted: 2020-10-27
Enrollment: 150
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Youth Initiation
timeFrame: Week 4
measure: Youth Initiation
timeFrame: Week 9
measure: Youth Initiation
timeFrame: Week 17
measure: Caregiver attendance with youth at 1 or more treatment appointment
timeFrame: Week 4
measure: Caregiver attendance with youth at 1 or more treatment appointment
timeFrame: Week 9
measure: Caregiver attendance with youth at 1 or more treatment appointment
timeFrame: Week 17
Secondary outcomes:
measure: Change in Youth Treatment Motivation as measured by the TCU MOT Form
timeFrame: Weeks 1, 9, and 17
measure: Change in Caregiver's Perception of Youth's Treatment Motivation as measured by the TCU MOT Form
timeFrame: Weeks 1, 9, and 17
measure: Change in Youth Normative Beliefs about Substance Use as measured by the TCU THK Form
timeFrame: Weeks 1, 9, and 17
measure: Change in Caregiver Normative Beliefs about Substance Use as measured by the TCU THK Form
timeFrame: Weeks 1, 9, and 17
measure: Change in Youth Perceived Control over Substance Use as measured by the TCU THK Form
timeFrame: Weeks 1, 9, and 17
measure: Change in Youth Perceived Control over Treatment Initiation as measured by the Barriers to Treatment Participation Scale (BTPS)
timeFrame: Weeks 1, 9, and 17
measure: Change in Caregiver Perceived Control over Youth's Substance Use as measured by the Caregiver Strain Questionnaire (CGSQ-SF7):
timeFrame: Weeks 1, 9, and 17
measure: Change in Caregiver Perceived Control over Youth's Treatment Initiation as measured by the Barriers to Treatment Participation Scale (BTPS)
timeFrame: Weeks 1, 9, and 17
measure: Change in Youth Intentions to Use Substances as measured by the TCU THK Form
timeFrame: Weeks 1, 5, 9, and 17
measure: Change in Youth Intentions to Initiate Treatment
timeFrame: Weeks 1, 5, 9, and 17
measure: Change in Caregiver Intentions to schedule and attend youth's treatment sessions
timeFrame: Weeks 1, 5, 9, and 17
measure: Change in Youth Substance Use as measured by the TCUDS and Opioid Supplement Forms
timeFrame: Weeks 1, 5, 9, and 17
measure: Change in Family relationships as measured by the TCU FFS Scale
timeFrame: Weeks 1, 9, and 17
measure: Change in Family responsiveness as measured by the Family Assessment Device (FAD)
timeFrame: Weeks 1, 9, and 17
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Texas Christian University
state: Texas
Study officials:
affiliation: Texas Christian University
name: Danica Knight, PhD
role: PRINCIPAL_INVESTIGATOR
References: