Pilot Test of Parent-Focused Cannabis-Related Actions and Practices Intervention for Adolescent Marijuana Abuse

Study Overview
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Brief Summary
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The randomized clinical trial involves the pilot-testing of a theory-guided, empirically based, and low-cost intervention designed for legal medical marijuana-using parents to enhance parenting behaviors that limit youth exposure to marijuana, reduce or halt youth marijuana use, and increase youth awareness of the harmful consequences of marijuana during the youth years. Parents will be randomized to an intervention condition or to a wait list control condition. Pre- and post-intervention assessments will evaluate parent and youth marijuana and other substance use, perceptions and attitudes about marijuana, parenting and family functioning, and youth behavioral health.

Detailed Description
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The Stage 1A/1B treatment development research will involve a mixed-methods approach to formulating the Cannabis Actions and Practices (CAP) intervention. CAP is a parent-focused intervention to help parent medical marijuana (MM) users address adolescent marijuana use. The pilot evaluation of CAP will be conducted with 60 MM parents who will be randomly assigned to CAP (n=30) or to a delayed CAP wait-list (WL) condition (n=30). Parents and their adolescents will be assessed at baseline and 3, and 6 months after baseline. Primary outcomes will be adolescent marijuana use and perceptions of marijuana harmfulness. Secondary outcomes will include parenting behaviors such as youth exposure to marijuana, communications discouraging adolescent marijuana use, and setting expectations. The investigators will also examine key targets of change, including changes in adolescent behavioral health, parent perceptions of marijuana harmfulness, parent monitoring, parent sense of competence, parent behavioral intentions, and family relationships. Parents assigned to the delayed CAP condition will receive the CAP intervention after a 3-month waiting period, and these participants will receive baseline and 3-month follow-up assessments. The study design and assessment schedule will afford the opportunity for both a between-groups test of the efficacy of CAP between intervention and delayed participants, as well as within-person test of pre- and post-intervention differences in the primary and secondary outcomes among all 60 parent/adolescent dyads. The between-groups arm of the proposed design will provide an initial evaluation of the causal effects of the CAP intervention on primary and secondary marijuana use outcomes. The within-person arm of the design will provide an assessment of the degree to which participating parents improve in targeted areas of skill development and functioning after receiving the CAP intervention. All between-groups and within-person intervention effects will be evaluated within an intent-to-treat analytic framework. The study is designed to evaluate the promise of CAP, a novel theory-guided, empirically based, brief early intervention, for helping parent legal medical marijuana users support marijuana abstinence in their marijuana-involved adolescents.

Official Title
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Development of the Cannabis Actions and Practices (CAP): A Parent-Focused Intervention to Address Adolescent Marijuana Use

Conditions
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Cannabis Use Disorder, Mild, Cannabis Use Disorder, Moderate

Intervention / Treatment
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* Behavioral: Cannabis Actions and Practices Resource for Parents


Participation Criteria
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Eligibility Criteria
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Parent Inclusion Criteria: Has a valid New Mexico medical marijuana card A biological or adoptive parent, step-parent or other parent figure who serves as the primary caregiver of a 13- to 17-year-old adolescent Parents and youth live together at least 40% of the time (i.e., minimum of 3 days per week) Reside in the greater Albuquerque, New Mexico area Has sufficient residential stability to permit probable contact at follow-up (e.g., not homeless at time of intake) Has sufficient English language skills to participate in the interventions and complete assessments Adolescent inclusion criteria: Reports marijuana use on at least one occasion Has sufficient English language skills to complete assessments Parent exclusion Criteria: Parent appears to have insufficient cognitive functioning to understand consent process, assessments and interventions Currently in drug treatment for a cannabis or other substance use disorder, whether medical or non-medical, and (3) a spouse or parenting partner is already enrolled in the study. Adolescent exclusion criteria: Has a valid New Mexico medical marijuana card Reports weekly use of an illicit drug (i.e., excluding alcohol, tobacco, or marijuana) Appears to have insufficient cognitive functioning to understand assent process and assessments A sibling is already participating in the study

Ages Eligible for Study
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Minimum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The pilot evaluation of CAP will be conducted with 60 MM parents who will be randomly assigned to CAP (n=30) or to a wait-list (WL) condition (n=30). Parents and their adolescents (n=120) will be assessed at baseline and at 3- and 6 months. WL parents will receive the CAP intervention after a 3-month waiting period and these participants will receive baseline and 3-month follow-up assessments. The study design and assessment schedule will allow both a between-groups test of the efficacy of CAP between intervention and delayed participants, as well as within-person test of pre- and post-intervention differences in the primary and secondary outcomes among all 60 parent/adolescent dyads.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CAP Intervention<br>CAP is a parent-focused intervention being developed to help parents in states with legalized medical marijuana to address adolescent marijuana use. The proposed intervention will address the effects of marijuana on adolescent behavioral health, brain development, and social functioning and enhance parent motivation to use CAP concepts. Guided by formative research, CAP will build skills and provide strategies to: (1) restrict adolescent exposure to cannabis products and parent cannabis use in the home, (2) improve parent communication about their own cannabis use and expectations about youth marijuana use, (3) improve monitoring, (4) increase positive reinforcement for youth abstinence, and (5) address parent negative emotions. Parents will meet in groups with an interventionist for two 75-minute sessions. Presentations, discussion, and roleplay will be used to help parents gain mastery of preventive parenting behaviors and related strategies to reduce adolescent marijuana use. | Behavioral: Cannabis Actions and Practices Resource for Parents<br>* The Cannabis Actions and Practices (CAP) resource is a parent-focused approach to help MM parents address marijuana use and attitudes by their adolescents. CAP includes information about the effects of marijuana on adolescent behavioral health, brain development, and social functioning. CAP also integrates motivational strategies to foster The CAP intervention focuses on building parenting skills and teaching strategies to: (1) limit adolescent exposure to cannabis products and parent cannabis use at home, (2) improve parent communication about their MM use, expectations about youth marijuana use, and attitudes about the potential harms of adolescent cannabis use, (3) improve monitoring, and (4) increase positive reinforcement for youth abstinence. Parents meet with an interventionist for two individual 75-minute sessions involving presentations, discussions, and behavioral rehearsal of key parenting skills.<br>* Other names: CAP;|
| No Intervention: Wait List<br>Parents randomly assigned to Wait List Delayed CAP (WL) will receive no intervention for the baseline to 3-month follow-up period. Thus, the WL condition will serve as a comparison group from baseline to the 3-month assessment point. After the 3-month follow-up assessment, WL parents will be offered the CAP intervention. The final assessment for the WL participants will function as a 3-month follow-up assessment, allowing us to aggregate data all 60 parent-adolescent dyads to conduct within group analyses of pre- to post-intervention change on key variables of interest. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adolescent Marijuana Use-Adolescent Report | The TLFB will be used to derive a measure of percent days of marijuana and other drug use in the past 12 weeks at three time points (baseline, 3-months follow-up, and 6-months follow-up) and analyzed to quantify change from baseline to 3-months and change from 3-months to 6-months. | baseline to 6-months | 
| Perceptions of Harmfulness of Marijuana Use Adolescent Report (PMHU-A) | The PMHU-A measure is based on items from the National Survey of Drug Use and Health (NSDUH). Five items from the NSDUH will be used to measure the respondent's perception about the harm of using marijuana pertaining to physical harm, harm to mental health, risk for marijuana dependence, risk for injuries, and harmful social consequences. Each item has the same response option (1=no risk, 2=some risk, 3=moderate risk, 4=high risk). Items will be summed to form a total score at each assessment point (range, 5-20), with the greater the scale score the more perceived risk. The PMHU will be used to derive a measure of perception of harm at three time points (baseline, 3-months follow-up, and 6-months follow-up) and analyzed to quantify change from baseline to 3-months and change from 3-months to 6-months. | baseline to 6-months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cannabis-Specific Parenting Practices | The Cannabis-Specific Parent Practices measure will include: self-reported medical marijuana in the presence of youth, parents' verbal discouragement of youth marijuana use, parent-adolescent communication about parent expectations for abstinence, and parent safety protocols for cannabis storage at home. Parents will be asked to rate 7 items on a 4-point Likert-type scale (1= strongly disagree; 2=disagree; 3=agree; 4=strongly agree) regarding extent of agreement with each item. The greater the item score, the more optimal the parenting practice. Each item of this measure (score range, 1-4) will be collected at three time points (baseline, 3-months follow-up, and 6-months follow-up) and analyzed as separate items to quantify change from baseline to 3-months and change from 3-months to 6-months. | baseline to 6-months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adolescent, Marijuana Abuse, Prevention, Early Treatment