Cannabis Use Disorder, MildCAPNCT04923230
Pilot Test of Parent-Focused Cannabis-Related Actions and Practices Intervention for Adolescent Marijuana Abuse
A study testing Cannabis Actions and Practices Resource for Parents in people with Cannabis Use Disorder, Mild and Cannabis Use Disorder, Moderate, run by Oregon Research Institute at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 13 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cannabis Use Disorder, Mild, Cannabis Use Disorder, Moderate
- What is being tested?
- Cannabis Actions and Practices Resource for Parents
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2021to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Family and Adolescent Research
Albuquerque, New Mexico, 87103
About this study
Official title: Development of the Cannabis Actions and Practices (CAP): A Parent-Focused Intervention to Address Adolescent Marijuana Use
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.
Read the 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.
- Being tested
- Cannabis Actions and Practices Resource for Parents
- Keywords
- Adolescent, Marijuana Abuse, Prevention, Early Treatment
- Medical subject headings
- Lymphoma, Follicular, Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cannabis Actions and Practices Resource for ParentsBehavioural
Also called CAP
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: baseline to 6-months
Secondary outcomes (1)
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.
Measured: baseline to 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2021
- Study start1 Jun 2021
- Primary completion31 May 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cannabis Use Disorder, MildStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Holly B Waldron, Ph.D., Principal investigator, Oregon Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04923230
- Sponsor's protocol ID
- R34DA049070
- Acronym
- CAP
- Status last verified
- Sep 2023
- First submitted
- 13 May 2021
- Last updated
- 26 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data will be shared with other researchers upon request.
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of the Cannabis Actions and Practices (CAP): A Parent-Focused Intervention to Address Adolescent Marijuana Use
- ClinicalTrials.gov ID
- NCT04923230
- Acronym / sponsor ID
- CAP / R34DA049070
- Keywords
- Adolescent, Marijuana Abuse, Prevention, Early Treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Oregon Research InstituteUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 11 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| CAP Intervention | Experimental | Behavioral: Cannabis Actions and Practices Resource for ParentsCAP 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. |
| 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. |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cannabis Actions and Practices Resource for ParentsAlso: CAPThe 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. | Behavioural | CAP Intervention |
Primary outcome
Adolescent Marijuana Use-Adolescent Report
Time frame: baseline to 6-months
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.
Perceptions of Harmfulness of Marijuana Use Adolescent Report (PMHU-A)
Time frame: baseline to 6-months
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.
1 secondary outcome
Cannabis-Specific Parenting Practices
Time frame: baseline to 6-months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2023.
- Individual participant dataSharing planned: Yes. De-identified data will be shared with other researchers upon request.
Related trials for Cannabis Use Disorder, Mild
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Cannabis Use Disorder, Mild, Cannabis Use Disorder, Moderate
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Holly B Waldron, Ph.D. principal investigator
Oregon Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cannabis Actions and Practices Resource for Parents in people with Cannabis Use Disorder, Mild and Cannabis Use Disorder, Moderate, run by Oregon Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adolescent Marijuana Use-Adolescent Report (time frame: baseline to 6-months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2023.