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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Must not have
Diagnosis of intellectual disability for adolescent
Lifetime substance use disorder (SUD) diagnosis for adolescent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing two programs for highly stressed parents of early adolescents. One program teaches mindfulness to help parents stay calm, while the other provides general parenting tips. The goal is to see which program better reduces stress and improves parenting.
Who is the study for?
This trial is for families with an adolescent aged 12-14 experiencing high stress. One caregiver must show significant stress and both the teen and at least one parent need to speak English well enough for surveys. Families can't join if the teen has intellectual disabilities, psychosis, or a past substance use disorder; or if any family member currently has untreated substance abuse (except tobacco) or active, untreated suicidality.
What is being tested?
The study compares two programs: Parenting Mindfully (PM) and Parent Education (PE). It aims to see which is more effective in reducing parenting stress and preventing adolescent substance abuse. Parents are randomly assigned to either PM or PE intervention groups.
What are the potential side effects?
Since this trial involves behavioral interventions rather than medications, traditional side effects are not expected. However, participants may experience emotional discomfort when discussing personal issues during sessions.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have been diagnosed with an intellectual disability.
Select...
I have been diagnosed with a substance use disorder in my lifetime.
Select...
I or my child currently have untreated suicidal thoughts.
Select...
I have been diagnosed with psychosis as a teenager.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Adolescent psychological symptoms
Adolescent substance use
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Parenting Mindfully (PM) InterventionExperimental Treatment1 Intervention
PM is an group based 8 week mindfulness intervention for parents.
Group II: Parent Education (PE) InterventionActive Control1 Intervention
PE is a group based 8 week educational intervention for parents that teaches parents about adolescent development.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for adolescent substance abuse include cognitive-behavioral therapy (CBT), mindfulness-based interventions, and family or parental involvement therapies. Mindfulness techniques, such as those studied in the Parenting Mindfully trial, work by enhancing self-awareness and emotional regulation, reducing stress, and improving coping skills.
These mechanisms are crucial for adolescents as they help manage triggers and cravings, reduce impulsive behaviors, and improve overall mental health. By involving parents and improving parenting skills, these treatments also create a supportive home environment, which is essential for the adolescent's recovery and long-term abstinence.
The contribution of mindfulness to outpatient substance use disorder treatment in Brazil: a preliminary study.Mindfulness-Oriented Recovery Enhancement versus CBT for co-occurring substance dependence, traumatic stress, and psychiatric disorders: Proximal outcomes from a pragmatic randomized trial.Mindfulness meditation and substance use in an incarcerated population.
The contribution of mindfulness to outpatient substance use disorder treatment in Brazil: a preliminary study.Mindfulness-Oriented Recovery Enhancement versus CBT for co-occurring substance dependence, traumatic stress, and psychiatric disorders: Proximal outcomes from a pragmatic randomized trial.Mindfulness meditation and substance use in an incarcerated population.
Find a Location
Who is running the clinical trial?
George Mason UniversityLead Sponsor
58 Previous Clinical Trials
48,521 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with an intellectual disability.I have been diagnosed with a substance use disorder in my lifetime.I or my child currently have untreated suicidal thoughts.I have a child aged between 12 and 14 years.I have been diagnosed with psychosis as a teenager.
Research Study Groups:
This trial has the following groups:- Group 1: Parenting Mindfully (PM) Intervention
- Group 2: Parent Education (PE) Intervention
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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