Evaluating Caregiver Involvement in Primary Care-Based Brief Interventions for Adolescent Alcohol Use Problems

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-17
SponsorIndiana University

About this trial

Intervention for mild severity alcohol use among U.S. teens is crucial, as alcohol is the most commonly used substance in this age group, yet few receive the necessary interventions. Primary care, where over 90% of youth regularly visit, is an ideal setting for identifying and addressing mild alcohol use disorder (AUD) through brief interventions like motivational interviewing (MI) and cognitive-behavioral therapy (CBT). However, for teens with mild AUD, a single brief session may not be sufficient, raising questions about the role of caregiver involvement. This study seeks to determine the most effective level of caregiver involvement-no involvement, a single live session, or an online self-paced program-in reducing alcohol use among adolescents with mild AUD in primary care settings. The study also explores the impact of these interventions on other outcomes such as substance use and psychosocial functioning, as well as the factors influencing treatment response. The results will guide the selection and implementation of effective, scalable interventions in primary care to address youth alcohol use disorders.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

12-17 years old;

Mild to moderate severity for alcohol use (based on standardized surveys from their primary care provider or clinical indication) or other substance use

English language fluency

Disqualifiers

N/A

Trial design

Design model

Parallel

Treatments tested in this trial

  • Teen Intervene - Adolescent Only

    Behavioral

    Teen Intervene (TI) is delivered over two or three, 45- to 60-minute sessions (2 teen sessions +/- 1 caregiver session) to reduce youth substance use, increase motivation for abstinence, and promote use of existing coping strategies. TI is an adolescent-appropriate adaptation of motivational enhancement therapy (MET), and includes a discussion of readiness to change, goal setting, personal feedback, a functional analysis of substance use, and a review of coping skills.

  • Teen Intervene with Caregiver Session

    Behavioral

    Teen Intervene (TI) is delivered over two or three, 45- to 60-minute sessions (2 teen sessions +/- 1 caregiver session) to reduce youth substance use, increase motivation for abstinence, and promote use of existing coping strategies. TI is an adolescent-appropriate adaptation of motivational enhancement therapy (MET), and includes a discussion of readiness to change, goal setting, personal feedback, a functional analysis of substance use, and a review of coping skills. In this condition, the caregiver session will address caregiver expectations around youth substance use and strategies for promoting positive youth behavior change including reduced substance use.

  • Family Check Up

    Behavioral

    Family Check-Up Online (FCU-O) is a self-paced, parent-driven, fully HIPAA compliant online version of the Family Check-Up (FCU), a brief intervention that integrates assessment, motivation-enhancement, and skill building to help parents effectively manage behavior and build positive relationships with their children aged 2-17 in order to reduce emotional and behavioral problems among youth.

Treatment groups

615 Participants
are divided into 3 treatment groups
Group A: Teen Intervene - Adolescent OnlyActive comparator 1 intervention
Group B: Teen Intervene - Caregiver InvolvementExperimental treatment 1 intervention
Group C: Teen Intervene - Online Caregiver Support ToolExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Timeline Follow-Back

30 items that assess daily alcohol usage over the past month will be administered to all participants. Participants will be queried about number of standard drinks consumed each day.

Time frame
*0-at time of intervention, *3 months after time of intervention; *6 months after time of intervention; *12 months after time of intervention

Secondary outcomes

1

Timeline Follow-Back

30 items that assess other substance usage over the past month will be administered to all participants. Participants will be queried about amount of each substance used for each day.

Time frame
*0-at time of intervention, *3 months after time of intervention; *6 months after time of intervention; *12 months after time of intervention
2

DAST-A

28 items that review AUD/SUD symptoms will be administered to all participants.

Time frame
*0-at time of intervention, *3 months after time of intervention; *6 months after time of intervention; *12 months after time of intervention
3

SUD Services Engagement

14 items that review youths services received by the participant (e.g., mental health treatment, substance use treatment, hospitalization) over the past 3 months per caregiver report. This will be asked to all participant caregivers.

Time frame
*0-at time of intervention, *3 months after time of intervention; *6 months after time of intervention; *12 months after time of intervention
4

PROMIS Surveys

37 items that review Psychosocial Functioning (Peer Relationships, Life Satisfaction, Depression, Anxiety, Anger/Irritability, and Psychological Stress Experiences). These items will be administered to all participants.

Time frame
*0-at time of intervention, *3 months after time of intervention; *6 months after time of intervention; *12 months after time of intervention

Other outcomes

1

Client Satisfaction Questionnaire

8 items that assesses adolescent/caregiver-reported implementation factors

Time frame
*0-at time of intervention, *3 months after time of intervention; *6 months after time of intervention; *12 months after time of intervention
2

Communities That Care Survey Family Factors

38 items that assesses family/caregiver practices

Time frame
*0-at time of intervention, *3 months after time of intervention; *6 months after time of intervention; *12 months after time of intervention
3

Acceptability, Feasibility, and Appropriateness of Intervention Measure

8 items that assesses interventionist-reported implementation factors

Time frame
once a year

Sponsors and contacts

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Indiana University

Lead sponsor

Patient-Centered Outcomes Research Institute

Collaborator