Clinical trial NCT04923230: Pilot Test of Parent-Focused Cannabis-Related Actions and Practices Intervention for Adolescent Marijuana Abuse
Official title: Development of the Cannabis Actions and Practices (CAP): A Parent-Focused Intervention to Address Adolescent Marijuana Use
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cannabis Use Disorder, Mild
Cannabis Use Disorder, Moderate
Keywords: Adolescent
Marijuana Abuse
Prevention
Early Treatment
Lead sponsor: Oregon Research Institute
Sponsor class: OTHER
First posted: 2021-06-11
Enrollment: 120
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Adolescent Marijuana Use-Adolescent Report
timeFrame: baseline to 6-months
measure: Perceptions of Harmfulness of Marijuana Use Adolescent Report (PMHU-A)
timeFrame: baseline to 6-months
Secondary outcomes:
measure: Cannabis-Specific Parenting Practices
timeFrame: baseline to 6-months
Other outcomes:
measure: Report of Parent Monitoring (PRM) Parent and Adolescent Forms
timeFrame: baseline to 6-months
measure: Family Environment Scale (FES)-Parent and Adolescent Forms
timeFrame: baseline to 6-months
measure: Perceptions of Harmfulness of Marijuana Use-Parent Collateral Report (PHMU-P) and Self-Report (PHMU)
timeFrame: baseline to 6-months
measure: Behavioral Intentions Questionnaire (BIQ) Parent Report
timeFrame: baseline to 6-months
measure: Parent Sense of Competence Scale (PSOC) Parent Form
timeFrame: baseline to 6-months
measure: Urine Toxicology Screen-Parent
timeFrame: baseline to 6-months
measure: Parent Cannabis Use (DFAQ-CU)
timeFrame: baseline, to 6-months
measure: Timeline Follow-back (TLFB) Parent Report
timeFrame: baseline to 6-months
measure: Adolescent Strengths and Difficulties Questionnaire (SDQ) Parent Report
timeFrame: baseline
Locations:
city: Albuquerque
country: United States
facility: Center for Family and Adolescent Research
state: New Mexico
Study officials:
affiliation: Oregon Research Institute
name: Holly B Waldron, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: