Active Linkage (AL) Clinical Trial
— FAMLIOfficial title:
Increasing Family Engagement and Treatment Initiation Through Family Assessment, Motivation,and Linkage Intervention (FAMLI)
| Verified date | September 2023 |
| Source | Texas Christian University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 150 |
| Est. completion date | April 17, 2023 |
| Est. primary completion date | April 17, 2023 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 12 Years to 18 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Texas Christian University | Fort Worth | Texas |
| Lead Sponsor | Collaborator |
|---|---|
| Texas Christian University |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | Caregiver attendance with youth at 1 or more treatment appointment | Caregiver attendance with youth at 1 or more treatment appointment (assessment, counseling) | Week 4 | |
| Primary | Caregiver attendance with youth at 1 or more treatment appointment | Caregiver attendance with youth at 1 or more treatment appointment (assessment, counseling) | Week 9 | |
| Primary | 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 | Change in Youth Treatment Motivation as measured by the TCU MOT Form | Change in motivation for treatment (problem recognition, desire for help, treatment readiness) | Weeks 1, 9, and 17 | |
| Secondary | Change in Caregiver's Perception of Youth's Treatment Motivation as measured by the TCU MOT Form | Change in motivation for treatment (recognition of youth's drug problem, desire for help, treatment readiness) | Weeks 1, 9, and 17 | |
| Secondary | Change in Youth Normative Beliefs about Substance Use as measured by the TCU THK Form | Change in beliefs about substance use (drug culture) | Weeks 1, 9, and 17 | |
| Secondary | Change in Caregiver Normative Beliefs about Substance Use as measured by the TCU THK Form | Change in beliefs about substance use (drug culture) | Weeks 1, 9, and 17 | |
| Secondary | Change in Youth Perceived Control over Substance Use as measured by the TCU THK Form | Change in perceived control over substance use | Weeks 1, 9, and 17 | |
| Secondary | Change in Youth Perceived Control over Treatment Initiation as measured by the Barriers to Treatment Participation Scale (BTPS) | Change in perceived control over treatment initiation (number of barriers to seeking and starting treatment) | Weeks 1, 9, and 17 | |
| Secondary | Change in Caregiver Perceived Control over Youth's Substance Use as measured by the Caregiver Strain Questionnaire (CGSQ-SF7): | Change in perceived control over youth's substance use (stressors and obstacles caused by youth's substance use) | Weeks 1, 9, and 17 | |
| Secondary | Change in Caregiver Perceived Control over Youth's Treatment Initiation as measured by the Barriers to Treatment Participation Scale (BTPS) | Change in perceived control over youth's treatment initiation (number of barriers to seeking and starting treatment) | Weeks 1, 9, and 17 | |
| Secondary | Change in Youth Intentions to Use Substances as measured by the TCU THK Form | Change in intention to use substances (drug resistance efficacy) and to initiate treatment | Weeks 1, 5, 9, and 17 | |
| Secondary | Change in Youth Intentions to Initiate Treatment | Change in intention to initiate treatment | Weeks 1, 5, 9, and 17 | |
| Secondary | Change in Caregiver Intentions to schedule and attend youth's treatment sessions | Change in intention to initiate youth's substance use treatment (intention to contact agency, intention to accompany child) | Weeks 1, 5, 9, and 17 | |
| Secondary | Change in Youth Substance Use as measured by the TCUDS and Opioid Supplement Forms | Self-reported use of substances (e.g., alcohol, marijuana, opioids), corroborated by urinalysis | Weeks 1, 5, 9, and 17 | |
| Secondary | Change in Family relationships as measured by the TCU FFS Scale | Change in quality of family relationships (warmth, control, conflict) | Weeks 1, 9, and 17 | |
| Secondary | Change in Family responsiveness as measured by the Family Assessment Device (FAD) | Change in quality of family affective responsiveness, affective involvement, behavior control) | Weeks 1, 9, and 17 |