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

NCT04923230 | Completed

• 1 other identifier: R34DA049070
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Cannabis Use Disorder, Mild; Cannabis Use Disorder, Moderate

Keywords

Adolescent; Marijuana Abuse; Prevention; Early Treatment

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Cannabis-Specific Parenting Practices

  baseline to 6-months

Other Outcomes (9)

• Report of Parent Monitoring (PRM) Parent and Adolescent Forms

  baseline to 6-months

• Family Environment Scale (FES)-Parent and Adolescent Forms

  baseline to 6-months

• Perceptions of Harmfulness of Marijuana Use-Parent Collateral Report (PHMU-P) and Self-Report (PHMU)

  baseline to 6-months

Study Arms (2)

CAP Intervention

EXPERIMENTAL

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

Wait List

NO INTERVENTION

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.

Interventions

Cannabis Actions and Practices Resource for Parents BEHAVIORAL

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.

Also known as: CAP

CAP Intervention

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Reports marijuana use on at least one occasion
• Has sufficient English language skills to complete assessments

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Oregon Research Institute: lead

Study Sites (1)

Center for Family and Adolescent Research

Albuquerque, New Mexico, 87103, United States

Location

MeSH Terms

Conditions

Lymphoma, Follicular; Marijuana Abuse

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Holly B Waldron, Ph.D.

  Oregon Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Assessors and investigators will not have knowledge of parent assignment to conditions.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 13, 2021
• First Posted: June 11, 2021
• Study Start: June 1, 2021
• Primary Completion: May 31, 2023
• Study Completion: June 30, 2023
• Last Updated: September 26, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will become available 5 months after publication of initial study findings and will be available for a period of 2 years.
• Access Criteria: Data will be shared with behavioral health researchers by written request for further analysis and publication of findings. The MPIs for the study will review requests. Review criteria to be determined.

Locations

US (1)