Mapping Enhanced Counseling (MEC)FAMLINCT04604236
Family Assessment Motivation, and Linkage Intervention (FAMLI)
A study testing Mapping Enhanced Counseling and Active Linkage in people with Mapping Enhanced Counseling (MEC) and Active Linkage (AL), run by Texas Christian University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Mapping Enhanced Counseling (MEC), Active Linkage (AL)
- What is being tested?
- Mapping Enhanced Counseling and Active Linkage
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jul 2022to 17 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- Mapping Enhanced Counseling, Active Linkage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mapping Enhanced CounselingBehavioural
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.
Active LinkageBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Active Linkage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Youth Initiation
Youth attendance at 1 or more treatment appointment (assessment or counseling), obtained through self-report and corroborated using probation agency attendance records
Measured: 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
Measured: 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
Measured: Week 17
Caregiver attendance with youth at 1 or more treatment appointment
Caregiver attendance with youth at 1 or more treatment appointment (assessment, counseling)
Measured: Week 4
Caregiver attendance with youth at 1 or more treatment appointment
Caregiver attendance with youth at 1 or more treatment appointment (assessment, counseling)
Measured: Week 9
Caregiver attendance with youth at 1 or more treatment appointment
Caregiver attendance with youth at 1 or more treatment appointment (assessment, counseling)
Measured: Week 17
Secondary outcomes (14)
Change in Youth Treatment Motivation as measured by the TCU MOT Form
Change in motivation for treatment (problem recognition, desire for help, treatment readiness)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: Weeks 1, 5, 9, and 17
Change in Youth Intentions to Initiate Treatment
Change in intention to initiate treatment
Measured: 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)
Measured: 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
Measured: 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)
Measured: 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)
Measured: Weeks 1, 9, and 17
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2020
- Study start7 Jul 2022
- Primary completion17 Apr 2023
- Study completion17 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mapping Enhanced Counseling (MEC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Christian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DanicaKnight, Texas Christian University
- Investigators
- Danica Knight, PhD, Principal investigator, Texas Christian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04604236
- Sponsor's protocol ID
- 1R34DA049079-01
- Acronym
- FAMLI
- Status last verified
- Sep 2023
- First submitted
- 15 Oct 2020
- Last updated
- 8 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Family Engagement and Treatment Initiation Through Family Assessment, Motivation,and Linkage Intervention (FAMLI)
- ClinicalTrials.gov ID
- NCT04604236
- Acronym / sponsor ID
- FAMLI / 1R34DA049079-01
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Texas Christian UniversityUniversity, hospital or other
- Study start
- 7 Jul 2022 (actual)
- Primary completion
- 17 Apr 2023 (actual)
- Study completion
- 17 Apr 2023 (actual)
- First posted
- 27 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mapping Enhanced Counseling (MEC) | Experimental | Behavioral: Mapping Enhanced CounselingMEC 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. |
| Active Linkage (AL) | Experimental | Behavioral: Active LinkageAL will target perceived control. Perceived control includes perceived logistical barriers and the degree to which individuals feel they can overcome them. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mapping Enhanced CounselingPractitioner-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. | Behavioural | Mapping Enhanced Counseling (MEC) |
| Active LinkagePractitioner-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). | Behavioural | Active Linkage (AL) |
Primary outcome
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
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
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
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)
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)
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)
14 secondary outcomes
Change in Youth Treatment Motivation as measured by the TCU MOT Form
Time frame: 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 Youth Normative Beliefs about Substance Use as measured by the TCU THK Form
Time frame: 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 Youth Perceived Control over Substance Use as measured by the TCU THK Form
Time frame: 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 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 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 Youth Intentions to Use Substances as measured by the TCU THK Form
Time frame: Weeks 1, 5, 9, and 17
Change in Youth Intentions to Initiate Treatment
Time frame: 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 Youth Substance Use as measured by the TCUDS and Opioid Supplement Forms
Time frame: 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 Family responsiveness as measured by the Family Assessment Device (FAD)
Time frame: Weeks 1, 9, and 17
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2023.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Danica Knight, PhD principal investigator
Texas Christian University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mapping Enhanced Counseling and Active Linkage in people with Mapping Enhanced Counseling (MEC) and Active Linkage (AL), run by Texas Christian University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Youth Initiation (time frame: Week 4). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2023.