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

Not Applicable

Terminated

• Conditions: Anxiety; Stress
• Interventions: Behavioral: Learning to BREATHE Plus; Behavioral: Health and wellness

• Registration Number: NCT03869749
• Lead Sponsor: Colorado State University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2019-02-14
• Study First Submitted QC: 2019-03-08
• Study First Posted: 2019-03-11
• Study Start: 2021-02-17
• Primary Completion: 2022-11-10
• Study Completion: 2022-11-10
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-21
• Last Update Posted: 2023-06-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Learning to BREATHE Plus	Learning to BREATHE Plus	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.
Health and wellness	Health and wellness	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Acceptability of interventions	Across 8-week intervention period	Rated by participants
Feasibility of implementation	Across 8-week intervention period	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)

Trial Locations

Locations (1)

Colorado State University; 🇺🇸 Fort Collins, Colorado, United States