Clinical trial NCT06593652: Evaluating Caregiver Involvement in Primary Care-Based Brief Interventions for Adolescent Alcohol Use Problems
Official title: Evaluating Caregiver Involvement in Primary Care-Based Brief Interventions for Adolescent Alcohol Use Problems
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alcohol Use
Adolescent
Mild Alcohol Use Disorder
Mild Substance Use Disorder
Keywords: Brief Intervention
Teen Intervene
Caregiver Involvement
Alcohol Use
Substance Use
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2024-09-19
Enrollment: 585
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Detailed Description

Intervention for mild severity alcohol use is needed in primary care. Alcohol is the most commonly used substance among U.S. teens (lifetime use: 62% of 12th graders) and contributes to myriad harms, yet few youth who may benefit from intervention ever receive it. Primary care is an ideal setting for identifying and delivering brief interventions to youth with mild severity alcohol problems since over 90% of youth attend primary care visits routinely and substance use screening is standard practice. For youth with infrequent, low-risk use, brief (15-30 minute) motivational conversations may be sufficient to reduce risk. In contrast, youth with moderate to severe alcohol problems typically require more intensive interventions delivered by behavioral health specialists (e.g., intensive outpatient, residential treatment). A critical decision faced in primary care settings is what to do for youth who fall between these ends of the spectrum-namely, youth who show early signs of problematic use, meeting criteria for mild severity alcohol use disorder (AUD) (i.e., 2-3 symptoms; estimated to be approximately 3% of youth aged 12-17). Strong evidence supports individual-level brief interventions that incorporate motivational interviewing (MI) and basic cognitive-behavioral therapy (CBT) skills to help youth reduce substance use frequency, volume, and related impairment among youth with mild AUD.

Caregiver involvement in brief interventions for mild severity AUD may improve outcomes. Systematic reviews support interventions that address family-level factors (e.g., parents' attitudes, parenting behavior). When and how to involve parents or other primary caregivers in interventions for youth with mild severity AUD remains unclear. For instance, in a large school-based trial, brief MI+CBT without a caregiver session was equivalent to brief MI+CBT with a caregiver session on alcohol outcomes and drug consequences, whereas the MI+CBT with a caregiver session modestly outperformed the adolescent-only condition on cannabis-related outcomes.

Directly intervening with caregivers can be difficult and impractical. Despite the potential benefits of caregiver involvement, many caregivers see their child's behavior and choices as the main concern and therefore may be less inclined to participate in services focused exclusively on parenting practices. Caregivers may also have to miss work for parenting-dedicated sessions, which can disproportionately impact economically disadvantaged families. Asynchronous online programming may address some of these barriers-and preliminary findings support acceptability and efficacy of this approach-but such programs remain understudied relative to more traditional program structures. Identifying the relative effectiveness of online versus in-person caregiver components compared to youth-only interventions is critical to support decisions and eventual cost-benefit analyses about which programs to offer to different patients.

The primary research question this study aims to address is, "What type and level of caregiver involvement in a brief youth-focused intervention (i.e., Teen Intervene) results in the greatest reductions in alcohol use among adolescents with mild alcohol use disorder when delivered in a primary care context: no caregiver involvement, a single dedicated parent session, or a self-paced online parenting program?" Secondary research questions are "What is the relative impact of the three intervention models on other substance, academic, and behavioral health outcomes?" and "Do youth (i.e., personality, alcohol/substance risk perceptions, etc.) and family factors (i.e., parental monitoring) moderate treatment response?" Understanding implementation factors associated with each intervention is also of interest, as engaging caregivers in youth SUD services can be challenging. Thus, the outcomes of the current project will help inform the selection and delivery of interventions that are both effective and reasonable to implement in primary care contexts, where most youth receive healthcare services. When delivered at scale, such interventions could help address the alcohol and other substance use disorders affecting the U.S. today.

Specific Aims

A Type 1 hybrid effectiveness-implementation trial is proposed to compare the effectiveness of an individual skill-building MI+CBT brief intervention (Teen Intervene, TI) with varying caregiver involvement: a) no caregiver involvement, b) a single live caregiver session, and c) an online, self-paced parenting program (Family Check-Up Online, FCU). These brief intervention programs will be tested as a first-level intervention to address mild AUD and prevent progression to more severe AUD symptoms or patterns of use. The aims are two-fold:

Aim 1: Compare the effectiveness of a youth-focused brief intervention (TI) when delivered without caregiver involvement (TI-A) versus with an added caregiver session (TI-A+P) versus with an online caregiver component (TI-A+FCU) in reducing alcohol use in adolescents with mild AUD in primary care. The overall magnitude of response and percentage of youth in each condition with clinically meaningful changes (i.e., % responders) will be measured. It is predicted that TI-A+P \> TI-A+FCU \> TI-A. Secondary outcomes will include other substance use (e.g., vaping, cannabis), AUD/SUD symptoms, general psychosocial functioning, and implementation factors including reactions to the intervention (e.g., satisfaction, acceptability, barriers).

Aim 2: Identify youth and family factors associated with intervention response versus non-response in each treatment condition, such as baseline substance use intensity (frequency, volume, duration, type), youth and caregiver perception of alcohol/substance use risk, youth personality factors (impulsivity, emotion dysregulation), and baseline parenting practices. Intervention implementation factors will also be examined. This aim will be accomplished through both quantitative and qualitative measures.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Timeline Follow-Back
timeFrame: *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:
measure: Timeline Follow-Back
timeFrame: *0-at time of intervention, *3 months after time of intervention; *6 months after time of intervention; *12 months after time of intervention
measure: DAST-A
timeFrame: *0-at time of intervention, *3 months after time of intervention; *6 months after time of intervention; *12 months after time of intervention
measure: SUD Services Engagement
timeFrame: *0-at time of intervention, *3 months after time of intervention; *6 months after time of intervention; *12 months after time of intervention
measure: PROMIS Surveys
timeFrame: *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:
measure: Client Satisfaction Questionnaire
timeFrame: *0-at time of intervention, *3 months after time of intervention; *6 months after time of intervention; *12 months after time of intervention
measure: Communities That Care Survey Family Factors
timeFrame: *0-at time of intervention, *3 months after time of intervention; *6 months after time of intervention; *12 months after time of intervention
measure: Acceptability, Feasibility, and Appropriateness of Intervention Measure
timeFrame: once a year
Locations:
city: Indianapolis
country: United States
facility: IU Health/Indiana University School of Medicine
state: Indiana
Study officials:
affiliation: Indiana University
name: Zachary Adams, PhD, HSPP
role: PRINCIPAL_INVESTIGATOR
affiliation: Indiana University
name: Tamika Zapolski, PhD, HSPP
role: PRINCIPAL_INVESTIGATOR
References: