Ignite Creation Date:
2024-10-25 @ 7:54 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06593652
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-28
Brief Title:
Evaluating Caregiver Involvement in Primary Care-Based Brief Interventions for Adolescent Alcohol Use Problems
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluating Caregiver Involvement in Primary Care-Based Brief Interventions for Adolescent Alcohol Use Problems
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Intervention for mild severity alcohol use among US 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 US 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 eg 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 ie 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 eg 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 MICBT without a caregiver session was equivalent to brief MICBT with a caregiver session on alcohol outcomes and drug consequences whereas the MICBT 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 childs 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 ie 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 ie personality alcoholsubstance risk perceptions etc and family factors ie 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 US today
Specific Aims
A Type 1 hybrid effectiveness-implementation trial is proposed to compare the effectiveness of an individual skill-building MICBT 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-AP versus with an online caregiver component TI-AFCU 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 ie responders will be measured It is predicted that TI-AP TI-AFCU TI-A Secondary outcomes will include other substance use eg vaping cannabis AUDSUD symptoms general psychosocial functioning and implementation factors including reactions to the intervention eg 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 alcoholsubstance 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
Intervention for mild severity alcohol use is needed in primary care Alcohol is the most commonly used substance among US 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 eg 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 ie 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 eg 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 MICBT without a caregiver session was equivalent to brief MICBT with a caregiver session on alcohol outcomes and drug consequences whereas the MICBT 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 childs 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 ie 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 ie personality alcoholsubstance risk perceptions etc and family factors ie 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 US today
Specific Aims
A Type 1 hybrid effectiveness-implementation trial is proposed to compare the effectiveness of an individual skill-building MICBT 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-AP versus with an online caregiver component TI-AFCU 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 ie responders will be measured It is predicted that TI-AP TI-AFCU TI-A Secondary outcomes will include other substance use eg vaping cannabis AUDSUD symptoms general psychosocial functioning and implementation factors including reactions to the intervention eg 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 alcoholsubstance 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None