The Moving 2 Mindful (M2M) Study: Mindfulness Group + Ecological Momentary Intervention

Study Overview
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Brief Summary
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This study will evaluate the feasibility and acceptability of Learning to BREATHE (a mindfulness intervention for adolescents) plus an ecological momentary intervention (Learning to Breathe Plus), and will examine the extent to which mindfulness reduces dysregulated stress physiology, perceived stress, and anxiety in adolescents from high conflict homes.

Detailed Description
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Adolescents from homes with interparental conflict will be randomly assigned to Learning to BREATHE Plus (the standard group program designed to increase mindfulness, plus a multi-method adaptive intervention that will be comprised of an ecological momentary intervention and online library of mindfulness practices) or to a health and wellness active control condition to determine feasibility, acceptability, and potential effectiveness of Learning to BREATHE Plus.

Official Title
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Decreasing Stress and Anxiety in Adolescents From High-Conflict Homes: Testing a Mindfulness Group + Ecological Momentary Intervention

Conditions
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Anxiety, Stress

Intervention / Treatment
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* Behavioral: Learning to BREATHE Plus
* Behavioral: Health and wellness


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: two parents in the home an adolescent who is between 14 and 18 years of age marital distress and/or problematic interparental conflict (based on parent or youth reports) youth reports of stress or anxiety Exclusion Criteria: two parents in the home, but they are pursuing legal divorce or separation parents are not willing to receive marital education/support adolescents are severely clinically depressed or report suicidal ideation at baseline

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be assigned to one of two study interventions in an open randomized trial.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Learning to BREATHE Plus<br>It is a 6-week manualized program; each meeting is 1.5 hours, for a total of 9 contact hours. It will be administered in a classroom at Colorado State University. Adolescents will be sent ecological momentary intervention text messages several times a day (with reminders, encouragement, and guides to practice mindfulness), and also have access to an on demand online library of mindfulness resources. | Behavioral: Learning to BREATHE Plus<br>* Activities include psycho-education about stress and emotion regulation, and practices of body scanning, non-aerobic yoga, and meditation, which are designed to cultivate and provide opportunities to practice present-focused, non-judgmental attention.<br>|
| Active Comparator: Health and wellness<br>It is a 6-week program; each meeting is 1.5 hours, for a total of 9 contact hours. It will be administered in a classroom at Colorado State University. | Behavioral: Health and wellness<br>* The Health Education Wellness Program (modeled after Hey Durham) (Bravender, 2005) will provide didactic information on substance use, nutrition/body image, stress management, exercise, and signs of depression/suicide.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safe implementation | Implementation without increase in symptomatology | Across 8-week intervention period | 
| Recruitment of target sample size | Successful recruitment of 38 families (114 individuals) | Across 8-week intervention period | 
| Enrollment of percent eligible | Enrolling a high percent of eligible families to the study/intervention | Across 8-week intervention period | 
| Retention to interventions | A high proportion of adolescents will attend 4/6 sessions | Across 8-week intervention period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of implementation | Successful implementation and retention to study (i.e., fidelity of intervention delivery >=80%, <=5% reports of not receiving ecological momentary intervention from adolescents, >=90% attendance at 4/6 sessions, >= retainment at post-group and follow-up) | Across 8-week intervention period | 
| Acceptability of interventions | Rated by participants | Across 8-week intervention period |