- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07700849
Brief Family-Based Cannabis Use Intervention for Youth With Early Juvenile Justice Involvement (JJ-CAPE)
The goal of this randomized clinical trial is to learn if a brief family-based intervention in effective in reducing cannabis use and delinquency in youth participating in juvenile diversion. The main questions it aims to answer are:
Hypothesis 1: the intervention will be (a) feasible, as evidenced by enrollment rates (> 80%), follow-up rates (> 80%), and withdrawal rates (< 20%); and (b) acceptable, as evidenced by > 80% of treatment evaluation ratings in the highest two Likert rating categories and positive exit interview feedback.
Hypothesis 2: those parents in the experimental condition, as compared to the active comparison psychoeducation condition, will evidence greater improvement over time in the hypothesized family-level mechanisms proposed in the intervention (i.e., parenting practices and parent well-being) as well as in youth-level outcomes, including cannabis use, recidivism, and HIV/STI risk.
Researchers will compare the family-based treatment to parenting psychoeducation. Caregiver and youth participants will complete measures relevant to primary outcomes and putative mechanisms at baseline, 3-month, and 6-month follow-ups.
Přehled studie
Postavení
Podmínky
Detailní popis
Approximately 50% of youth with early juvenile justice system (JJS) involvement (i.e., diverted youth with less severe or first-time arrest histories) screen positive for cannabis use.Cannabis use is especially problematic for youth with early JJS involvement, given research suggesting that cannabis use is linked with continued and chronic involvement in the JJS. Moreover, cannabis use among justice-involved youth (JIY) is also associated with other consequences, including HIV/STI risk behaviors (e.g., lack of condom usage). Early JIY who use cannabis also differ from youth without justice involvement, such that they are more likely to belong to marginalized communities and also evidence worse family functioning. Thus, this population warrants specialized interventions targeting cannabis use and associated consequences.
To date, the most effective cannabis and other substance use interventions for youth in the JJS are largely intensive, personalizable family-based models (e.g., multisystemic therapy), which also have documented efficacy in reducing the risk for HIV/STIs and long-term criminal involvement. However, these models were intended for youth with serious juvenile justice involvement and, thus, early JIY are rarely referred to these services.21 Such models are also likely overly intensive for treating cannabis use among early JIY. Despite evidence suggesting parenting practices, parent well-being, and family functioning are linked to cannabis use, delinquency, and HIV/STI risk behaviors for early JIY, there is a concerning lack of family-based services addressing cannabis use and other risk behaviors specifically developed for early JIY. Therefore, there is still a need for family-based interventions for early JIY. However, these interventions should be briefer in nature, so that they can be implemented as part of a larger continuum of care within the JJS.
The primary goal of this NIDA-funded K23 research project is to adapt an existing evidence-based family-based intervention to families of early JIY who screen positive for cannabis use. The proposed 6-session, modular, family-based intervention will be delivered via telehealth and primarily focus on changing parent behaviors, consistent with prior family-based interventions for the present population.The modules will focus on: 1) psychoeducation delivered in motivational interviewing style (e.g., encouraging caregivers' role in preventing substance use), 2) parenting practices (e.g., supervision, managing peer relations), and 3) parent well-being (e.g., increasing social support). Family intervention strategies across these modules will be adapted from existing evidence-based interventions and personalized to best meets each youth and parents' clinical needs (consistent with NIDA Goal 2.3). Our objective will be to understand the initial efficacy of the intervention in treating adolescent cannabis use and other important, related outcomes (e.g., HIV/STI risk behaviors) through a pilot randomized clinical trial (RCT).
Primary aim. Evaluate the acceptability, feasibility, and initial family-level mechanisms and youth substance-use related outcomes of a brief, family-based intervention for early justice-involved youths. A pilot RCT (N = 60) will be conducted in which youth and families will be randomized to either the proposed family-based intervention or parent psychoeducation. The youth and their primary caregiver will participate in these conditions via telehealth and will complete follow-up assessments at 3 and 6 months. H1: the intervention will be (a) feasible, as evidenced by enrollment rates (> 80%), follow-up rates (> 80%), and withdrawal rates (< 20%); and (b) acceptable, as evidenced by > 80% of treatment evaluation ratings in the highest two Likert rating categories and positive exit interview feedback. H2: is that those parents in the experimental condition, as compared to the active comparison psychoeducation condition, will evidence greater improvement over time in the hypothesized family-level mechanisms proposed in the intervention (i.e., parenting practices and parent well-being) as well as in youth-level outcomes, including cannabis use, recidivism, and HIV/STI risk.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Kaitlin Sheerin, PhD
- Telefonní číslo: (401) 444-8945
- E-mail: ksheerin@brownhealth.org
Studijní místa
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Rhode Island
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Providence, Rhode Island, Spojené státy, 02903
- Bradley-Hasbro Children's Research Center
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Kontakt:
- Kaitlin Sheerin, PhD
- Telefonní číslo: (401) 444-8945
- E-mail: ksheerin@brownhealth.org
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria: 1) parent and youth are English or Spanish speaking, 2) legal guardian is able to consent for their own and juvenile's participation, 3) youth flags for CU on either the Drug/Alcohol scale of the MAYSI-2 or on the CRAFFT 2.0, 4) not currently in substance use treatment elsewhere, and 5) youth currently residing in the community.
Exclusion Criteria: Youth and parents will not be able to participate in the present study if they have developmental or cognitive delays or a major psychiatric disorder, documented in the intake materials, that would interfere with completing consent, assessments, or the intervention
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: Family-based intervention
The family-based intervention is proposed as 6 sessions long and will have the following modules: 1) Introduction to Treatment; 2) Parent Training Strategies (clinician must cover at least 1 topic from this module); 3) Improving Parent Well-Being (clinician must cover at least 1 topic from this module); and 4) Treatment Termination and Future Planning (see Table 1 for information regarding modules and session content).
Youth will attend the first and last session, in addition to other relevant sessions (e.g., household rules/consequences); parents will attend every session.
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The intervention is proposed as 6 sessions long and will have the following modules: 1) Introduction to Treatment; 2) Parent Training Strategies (clinician must cover at least 1 topic from this module); 3) Improving Parent Well-Being (clinician must cover at least 1 topic from this module); and 4) Treatment Termination and Future Planning.
Youth may attend the first and last session, in addition to other relevant sessions (e.g., household rules/consequences); parents will attend every session.
Clinicians will use measures available from the baseline assessment relevant to treatment mechanisms (i.e., indices of parent well-being and parenting skills, the initial clinical interview from the first session, and the family's treatment goals to determine session content.
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Aktivní komparátor: Parenting Psychoeducation
Psychoeducation in the comparison group will involve 6 hour-long sessions delivered via secure videoconferencing focused on providing parents with key developmental knowledge regarding adolescence and parenting.
To differentiate the psychoeducation provided in the intervention group, sessions will focus on typical adolescent development and parenting knowledge derived from Centers for Disease Control publicly available information.
The first two sessions will provide information about typical developmental milestones in adolescence (e.g., increased need for privacy and independence).
The third and fourth session will provide information on healthy vs. unhealthy behaviors in adolescence (e.g., safe driving behaviors).
Finally, the final two sessions will give parents' knowledge regarding general positive parenting practices to shape healthy adolescent development.
This is an active comparison condition seeking to change parents' parenting knowledge regarding typical challenges parent
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Psychoeducation in the comparison group will involve 6 hour-long sessions delivered via secure videoconferencing focused on providing parents with key developmental knowledge regarding adolescence and parenting.
To differentiate the psychoeducation provided in the intervention group, sessions will focus on typical adolescent development and parenting knowledge derived from Centers for Disease Control publicly available information.The first two sessions will provide information about typical developmental milestones in adolescence (e.g., increased need for privacy and independence).
The third and fourth session will provide information on healthy vs. unhealthy behaviors in adolescence (e.g., safe driving behaviors).
Finally, the final two sessions will give parents' knowledge regarding general positive parenting practices to shape healthy adolescent development.
This is an active comparison condition seeking to change parents' parenting knowledge regarding typical challenges parents
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Timeline Follow-Back
Časové okno: The Timeline Follow-Back will be administered at baseline, 3-months, and 6-months post baseline.
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This youth report measure assess for past 90-day youth cannabis, alcohol, other drug use, as well as risky sexual behaviors on use days.
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The Timeline Follow-Back will be administered at baseline, 3-months, and 6-months post baseline.
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Official arrest records
Časové okno: Official arrest records will be collected for the 12 months following baseline.
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Official arrest records will be collected as an index of recidivism among youth.
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Official arrest records will be collected for the 12 months following baseline.
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Marijuana Adolescent Problem Inventory
Časové okno: We will collect this measure at baseline, 3-months, and 6-months post baseline.
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This youth-reported measure assesses for cannabis-related consequences among youth.
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We will collect this measure at baseline, 3-months, and 6-months post baseline.
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Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další identifikační čísla studie
- 2079613
- K23DA058014 (Grant/smlouva NIH USA)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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