Adolescent Substance UseNCT05370768
Parenting Mindfully Study II
A study testing Parenting Mindfully Intervention in people with Adolescent Substance Use and Adolescent Psychological Symptoms, run by George Mason University at 1 site in United States.
Trial summary
This study will conduct a large Randomized Controlled Trial to test effects of a parenting mindfully (PM) intervention versus a parent education (PE) intervention for highly stressed parents of adolescents. Read more about this study
- Who is it for?
- Ages 12 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Adolescent Substance Use, Adolescent Psychological Symptoms, Parent Stress
- What is being tested?
- Parenting Mindfully Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 269 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2022to 31 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Family with adolescent between 12-14 years;
- High stress levels for at least one primary caregiver (referred to as "parents" throughout the application, but not required to be biological parents) on stress screener;
- Adequate English proficiency to complete questionnaires for adolescent and at least one parent (because several of our questionnaires have not been validated for use in other languages)
Who cannot join
- Diagnosis of intellectual disability for adolescent or psychosis for adolescent;
- Current active suicidality that is untreated for parent or adolescent (We will refer participants with active suicidality for inpatient treatment. They will be eligible to participate in the study once stabilized),
- Current SUDs that are untreated for parent except Tobacco Use Disorder (because participants must to be able to refrain from substances except nicotine/tobacco during the PAIT lab session day safely without withdrawal symptoms). We will refer parents with active SUDs to treatment. They will be eligible to participate in the study once stabilized and in treatment.
- Lifetime SUD diagnosis for adolescent because an aim of the study is SUD prevention.
- Note: We are recruiting for about 130 of the primary caregiver parents to be eligible in and interested in completing functional magnetic resonance imaging (fMRI) scans are pre and post-intervention. If we do not meet this number, we will restrict recruitment to those families with one parent who is interested in and eligible for fMRI.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Neurobiological Mechanisms of a Parenting-focused Mindfulness Intervention to Prevent Adolescent Substance Use
This study will conduct a large Randomized Controlled Trial to test effects of a parenting mindfully (PM) intervention versus a parent education (PE) intervention for highly stressed parents of adolescents.
Read the detailed description
Parents of early adolescents who report experiencing stress will be randomly assigned to receive the 8 week PM or PE intervention. Before, during, and after the interventions, and at 6 month, 1 year, and 2 year follow-ups (into middle adolescence), the researchers will collect questionnaire, interview, and biological measures of parent stress, parenting, and adolescent substance use and psychological symptoms. At pre- and post-intervention, observed parenting and stress reactivity will be measured in a parent-adolescent interaction task. Some mothers will also complete fMRI sessions at pre- and post- examining emotion-related neurobiological mechanisms.
- Being tested
- Parenting Mindfully Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parenting Mindfully InterventionBehavioural
Includes meditation and using meditation and mindfulness in everyday life and in parenting interactions.
| Study group | Role | What they receive |
|---|---|---|
| Parenting Mindfully (PM) Intervention | Experimental | PM is an group based 8 week mindfulness intervention for parents. Receives: Behavioral: Parenting Mindfully Intervention |
| Parent Education (PE) Intervention | Active comparator | PE is a group based 8 week educational intervention for parents that teaches parents about adolescent development. Receives: Behavioral: Parenting Mindfully Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adolescent substance use
frequency and amount of substance use This will be based on combining (in a composite score) information from the Youth Risk Behavior Survey, Urine and Breath Screens, and the Timeline Follow Back Interview to determine frequency and amount of use. To combine, we will first transform all measures into z-scores (standardized scores) and then will combine them (either through composite scoring or through SEM latent variables).
Measured: 2 years
Adolescent psychological symptoms
youth self reported symptoms on the Youth Inventory and parent reported symptoms on the Child Symptom Inventory will be combined or, if needed, tested separately in analyses. To combine, we will first transform all measures into z-scores (standardized scores) and then will combine them (either through composite scoring or through SEM latent variables).
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2022
- Study start1 Apr 2022
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent Substance UseStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 269 participants (actual)
Sponsor and investigators
- Lead sponsor
- George Mason University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tara M. Chaplin, Ph.D., George Mason University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05370768
- Sponsor's protocol ID
- 1770931-1
- Status last verified
- Sep 2026
- First submitted
- 11 Apr 2022
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Neurobiological Mechanisms of a Parenting-focused Mindfulness Intervention to Prevent Adolescent Substance Use
- ClinicalTrials.gov ID
- NCT05370768
- Acronym / sponsor ID
- 1770931-1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 269 participants (actual)
- Lead sponsor
- George Mason UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 12 May 2022 (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.
This study will conduct a large Randomized Controlled Trial to test effects of a parenting mindfully (PM) intervention versus a parent education (PE) intervention for highly stressed parents of adolescents.
Detailed description
Parents of early adolescents who report experiencing stress will be randomly assigned to receive the 8 week PM or PE intervention. Before, during, and after the interventions, and at 6 month, 1 year, and 2 year follow-ups (into middle adolescence), the researchers will collect questionnaire, interview, and biological measures of parent stress, parenting, and adolescent substance use and psychological symptoms. At pre- and post-intervention, observed parenting and stress reactivity will be measured in a parent-adolescent interaction task. Some mothers will also complete fMRI sessions at pre- and post- examining emotion-related neurobiological mechanisms.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parenting Mindfully (PM) Intervention | Experimental | Behavioral: Parenting Mindfully InterventionPM is an group based 8 week mindfulness intervention for parents. |
| Parent Education (PE) Intervention | Active comparator | Behavioral: Parenting Mindfully InterventionPE is a group based 8 week educational intervention for parents that teaches parents about adolescent development. |
Who may qualify
- Ages
- 12 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Family with adolescent between 12-14 years;
- High stress levels for at least one primary caregiver (referred to as "parents" throughout the application, but not required to be biological parents) on stress screener;
- Adequate English proficiency to complete questionnaires for adolescent and at least one parent (because several of our questionnaires have not been validated for use in other languages)
Key exclusion criteria (5 listed)
- Diagnosis of intellectual disability for adolescent or psychosis for adolescent;
- Current active suicidality that is untreated for parent or adolescent (We will refer participants with active suicidality for inpatient treatment. They will be eligible to participate in the study once stabilized),
- Current SUDs that are untreated for parent except Tobacco Use Disorder (because participants must to be able to refrain from substances except nicotine/tobacco during the PAIT lab session day safely without withdrawal symptoms). We will refer parents with active SUDs to treatment. They will be eligible to participate in the study once stabilized and in treatment.
- Lifetime SUD diagnosis for adolescent because an aim of the study is SUD prevention.
- Note: We are recruiting for about 130 of the primary caregiver parents to be eligible in and interested in completing functional magnetic resonance imaging (fMRI) scans are pre and post-intervention. If we do not meet this number, we will restrict recruitment to those families with one parent who is interested in and eligible for fMRI.
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 InterventionIncludes meditation and using meditation and mindfulness in everyday life and in parenting interactions. | Behavioural | Parent Education (PE) Intervention, Parenting Mindfully (PM) Intervention |
Primary outcome
Adolescent substance use
Time frame: 2 years
frequency and amount of substance use This will be based on combining (in a composite score) information from the Youth Risk Behavior Survey, Urine and Breath Screens, and the Timeline Follow Back Interview to determine frequency and amount of use. To combine, we will first transform all measures into z-scores (standardized scores) and then will combine them (either through composite scoring or through SEM latent variables).
Adolescent psychological symptoms
Time frame: 2 years
youth self reported symptoms on the Youth Inventory and parent reported symptoms on the Child Symptom Inventory will be combined or, if needed, tested separately in analyses. To combine, we will first transform all measures into z-scores (standardized scores) and then will combine them (either through composite scoring or through SEM latent variables).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Individual participant dataSharing planned: No
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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 Intervention in people with Adolescent Substance Use and Adolescent Psychological Symptoms, 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 3 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 15 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
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 substance use (time frame: 2 years). 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 15 Sep 2026.