Substance AbusePMNCT02038231
Parenting Mindfully Study
A study testing Parenting Mindfully Program and Parent Education Program in people with Substance Abuse and Risk Behaviors, run by George Mason University at 1 site in United States.
Trial summary
The goal of study is to develop and test a parenting-focused version of mindfulness intervention ("Parenting Mindfully") to reduce parent stress and prevent adolescent substance use and HIV risk behaviors (e.g., risky sex). Read more about this study
- Who is it for?
- Ages 12 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Substance Abuse, Risk Behaviors
- What is being tested?
- Parenting Mindfully Program and Parent Education Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to Jul 2019
- 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 12 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Family with a child between 12-16 years;
- High parenting stress (mean score of >=3 on 2 questions adapted from the Perceived Stress Scale and the Parenting Stress Index).
Who cannot join
- Diagnosis of mental retardation, autism or other pervasive developmental disorder for adolescent;
- Current serious psychiatric or medical disorder (including current substance dependence) requiring immediate treatment for adolescent or parent- We will include those that are in treatment;
- Medical condition that would preclude participation in gentle yoga (for parents)
- Inadequate English proficiency to complete questionnaires for youth or parents.
Trial locations and contacts
1 site in 1 country.
United States1 site
George Mason University Department of Psychology
Fairfax, Virginia, 22030
About this study
Official title: Reducing Stress With Parenting-focused Mindfulness to Prevent Youth Substance Use
The goal of study is to develop and test a parenting-focused version of mindfulness intervention ("Parenting Mindfully") to reduce parent stress and prevent adolescent substance use and HIV risk behaviors (e.g., risky sex). The investigators hypothesize that Parenting Mindfully (PM) will decrease prevent adolescent substance use and HIV risk behaviors and intentions. Secondarily, PM will improve parenting, and decrease adolescent stress responses.
- Conditions
- Substance Abuse, Risk Behaviors
- Being tested
- Parenting Mindfully Program, Parent Education Program
- Keywords
- Adolescence, Substance abuse, Mindfulness
- Medical subject headings
- Substance-Related Disorders, Risk-Taking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parenting Mindfully ProgramBehavioural
see Arm Description.
Parent Education ProgramOther
See Arm Description.
| Study group | Role | What they receive |
|---|---|---|
| Parenting Mindfully Program | Experimental | Mindfulness program for parents of adolescents provided for 2 hours once per week for 8 weeks. Receives: Behavioral: Parenting Mindfully Program |
| Parent Education Program | Active comparator | Group for parents of adolescents providing handouts and brief education to parents on topics of adolescence, family relations, and risk behaviors. Group meets 3 times over the course of 8 weeks for about 15 minutes per meeting. Receives: Other: Parent Education Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Substance Use from pre-intervention through 12 months after the intervention
Measured by a combination of self-report on the Youth Risk Behavior Survey and a drug-use intentions questionnaire and urine toxicology and alcohol breathalyzer results.
Measured: Pre-intervention, immediately post-intervention (8 weeks after the pre-intervention session), 6 months after the post-intervention session, and 12-month after the post-intervention session
Change in Adolescent Sex Behaviors from Pre-intervention Through 12 months following the intervention
Measured by self-report of onset of sex and risky sex behaviors on the Youth Risk Behavior Survey and a risky sexual behavior and intention questionnaire.
Measured: Pre-intervention, immediately post-intervention (8 weeks after the pre-intervention session), 6 months after the post-intervention session, and 12-month after the post-intervention session
Secondary outcomes (2)
Change in Parenting from Pre-Intervention to Post-Intervention
Measured by self-reported parenting behaviors on the Alabama Parenting Questionnaire and by parenting behaviors coded from videotapes of parent-adolescent interactions.
Measured: Pre-intervention, immediately post-intervention (8 weeks after the pre-intervention session)
Change in Adolescent Stress Responses from Pre-Intervention to Post-Intervention
Measured by adolescent's reported emotions, observed emotion expressions, and heart rate, blood pressure, and cortisol levels in response to stressful parent-adolescent interactions.
Measured: Pre-intervention, immediately post-intervention (8 weeks after the pre-intervention session)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2014 (estimated)
- Study startFeb 2014
- Primary completionFeb 2018
- Study completionJul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Substance AbuseStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- George Mason University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Inova Fairfax Hospital
- Responsible party
- Principal investigator, Tara M. Chaplin, Ph.D., George Mason University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02038231
- Sponsor's protocol ID
- 8753
- Other IDs
- R34DA034823
- Acronym
- PM
- Status last verified
- Aug 2019
- First submitted
- 13 Jan 2014
- Last updated
- 7 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Chaplin TM, Mauro KL, Curby TW, Niehaus C, Fischer S, Turpyn CC, Martelli AM, Miller AB, Leichtweis RN, Baer R, Sinha R. Effects of A Parenting-Focused Mindfulness Intervention on Adolescent Substance Use and Psychopathology: A Randomized Controlled Trial. Res Child Adolesc Psychopathol. 2021 Jul;49(7):861-875. doi: 10.1007/s10802-021-00782-4. Epub 2021 Feb 23.
PubMed 33620662
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Stress With Parenting-focused Mindfulness to Prevent Youth Substance Use
- ClinicalTrials.gov ID
- NCT02038231
- Acronym / sponsor ID
- PM / 8753
- Conditions
- Substance Abuse, Risk Behaviors
- Keywords
- Adolescence, Substance abuse, Mindfulness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- George Mason UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Inova Fairfax Hospital
- Study start
- Feb 2014
- Primary completion
- Feb 2018 (actual)
- Study completion
- Jul 2019 (actual)
- First posted
- 16 Jan 2014 (estimated)
- 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 goal of study is to develop and test a parenting-focused version of mindfulness intervention ("Parenting Mindfully") to reduce parent stress and prevent adolescent substance use and HIV risk behaviors (e.g., risky sex). The investigators hypothesize that Parenting Mindfully (PM) will decrease prevent adolescent substance use and HIV risk behaviors and intentions. Secondarily, PM will improve parenting, and decrease adolescent stress responses.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parenting Mindfully Program | Experimental | Behavioral: Parenting Mindfully ProgramMindfulness program for parents of adolescents provided for 2 hours once per week for 8 weeks. |
| Parent Education Program | Active comparator | Other: Parent Education ProgramGroup for parents of adolescents providing handouts and brief education to parents on topics of adolescence, family relations, and risk behaviors. Group meets 3 times over the course of 8 weeks for about 15 minutes per meeting. |
Who may qualify
- Ages
- 12 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Family with a child between 12-16 years;
- High parenting stress (mean score of >=3 on 2 questions adapted from the Perceived Stress Scale and the Parenting Stress Index).
Key exclusion criteria (4 listed)
- Diagnosis of mental retardation, autism or other pervasive developmental disorder for adolescent;
- Current serious psychiatric or medical disorder (including current substance dependence) requiring immediate treatment for adolescent or parent- We will include those that are in treatment;
- Medical condition that would preclude participation in gentle yoga (for parents)
- Inadequate English proficiency to complete questionnaires for youth or parents.
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 |
|---|---|---|
| Parenting Mindfully Programsee Arm Description. | Behavioural | Parenting Mindfully Program |
| Parent Education ProgramSee Arm Description. | Other | Parent Education Program |
Primary outcome
Change in Substance Use from pre-intervention through 12 months after the intervention
Time frame: Pre-intervention, immediately post-intervention (8 weeks after the pre-intervention session), 6 months after the post-intervention session, and 12-month after the post-intervention session
Measured by a combination of self-report on the Youth Risk Behavior Survey and a drug-use intentions questionnaire and urine toxicology and alcohol breathalyzer results.
Change in Adolescent Sex Behaviors from Pre-intervention Through 12 months following the intervention
Time frame: Pre-intervention, immediately post-intervention (8 weeks after the pre-intervention session), 6 months after the post-intervention session, and 12-month after the post-intervention session
Measured by self-report of onset of sex and risky sex behaviors on the Youth Risk Behavior Survey and a risky sexual behavior and intention questionnaire.
2 secondary outcomes
Change in Parenting from Pre-Intervention to Post-Intervention
Time frame: Pre-intervention, immediately post-intervention (8 weeks after the pre-intervention session)
Change in Adolescent Stress Responses from Pre-Intervention to Post-Intervention
Time frame: Pre-intervention, immediately post-intervention (8 weeks after the pre-intervention session)
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 7 Aug 2019.
- Derived from this study: PubMed 33620662Chaplin TM, Mauro KL, Curby TW, Niehaus C, Fischer S, Turpyn CC, Martelli AM, Miller AB, Leichtweis RN, Baer R, Sinha R. Effects of A Parenting-Focused Mindfulness Intervention on Adolescent Substance Use and Psychopathology: A Randomized Controlled Trial. Res Child Adolesc Psychopathol. 2021 Jul;49(7):861-875. doi: 10.1007/s10802-021-00782-4. Epub 2021 Feb 23.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parenting Mindfully Program and Parent Education Program in people with Substance Abuse and Risk Behaviors, run by George Mason University 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?
The sponsor lists 2 inclusion and 4 exclusion criteria. 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 7 Aug 2019. 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?
Change in Substance Use from pre-intervention through 12 months after the intervention (time frame: Pre-intervention, immediately post-intervention (8 weeks after the pre-intervention session), 6 months after the post-intervention session, and 12-month after the post-intervention session). 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?
On the ClinicalTrials.gov record for NCT02038231, which also lists 1 linked publication.
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 7 Aug 2019.