Family Assessment Motivation, and Linkage Intervention (FAMLI) (FAMLI)

Increasing Family Engagement and Treatment Initiation Through 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.

Study Overview

• Status: Completed
• Conditions: Mapping Enhanced Counseling (MEC); Active Linkage (AL)
• Intervention / Treatment: Behavioral: Mapping Enhanced Counseling; Behavioral: Active Linkage

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Fort Worth, Texas, United States, 76109
      • Texas Christian University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 17 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mapping Enhanced Counseling (MEC); 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; 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.
Experimental: Active Linkage (AL); 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; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Caregiver attendance with youth at 1 or more treatment appointment	Caregiver attendance with youth at 1 or more treatment appointment (assessment, counseling)	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 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 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 17

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
Change in Youth Intentions to Initiate Treatment	Change in intention to initiate treatment	Weeks 1, 5, 9, and 17
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
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
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
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

Collaborators and Investigators

• Sponsor: Texas Christian University
• Investigators: Principal Investigator: Danica Knight, PhD, Texas Christian University

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2022
• Primary Completion (Actual): April 17, 2023
• Study Completion (Actual): April 17, 2023

Study Registration Dates

• First Submitted: October 15, 2020
• First Submitted That Met QC Criteria: October 21, 2020
• First Posted (Actual): October 27, 2020

Study Record Updates

• Last Update Posted (Actual): September 8, 2023
• Last Update Submitted That Met QC Criteria: September 5, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 1R34DA049079-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No