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

September 5, 2023 updated by: DanicaKnight, Texas Christian University

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Jennifer Becan, PhD
  • Phone Number: 8172576518
  • Email: j.becan@tcu.edu

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Week 9
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)
Week 9
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
Week 4
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
Week 17
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)
Week 4
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)
Week 17

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
Weeks 1, 9, and 17
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)
Weeks 1, 9, and 17
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)
Weeks 1, 9, and 17
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)
Weeks 1, 9, and 17
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
Weeks 1, 9, and 17
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)
Weeks 1, 9, and 17
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)
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)
Time Frame: Weeks 1, 9, and 17
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
Time Frame: Weeks 1, 5, 9, and 17
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
Time Frame: Weeks 1, 5, 9, and 17
Change in intention to initiate treatment
Weeks 1, 5, 9, and 17
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)
Weeks 1, 5, 9, and 17
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
Weeks 1, 5, 9, and 17
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)
Weeks 1, 9, and 17
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)
Weeks 1, 9, and 17

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Texas Christian University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Danica Knight, PhD, Texas Christian University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 7, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 17, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 17, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 15, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 21, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 27, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 8, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 5, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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