Clinical trial NCT03869749: The Moving 2 Mindful (M2M) Study: Mindfulness Group + Ecological Momentary Intervention
Official title: Decreasing Stress and Anxiety in Adolescents From High-Conflict Homes: Testing a Mindfulness Group + Ecological Momentary Intervention
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Anxiety
Stress
Lead sponsor: Colorado State University
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2019-03-11
Enrollment: 5
Sex: ALL
Minimum age (years): 14
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be assigned to one of two study interventions in an open randomized trial.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Safe implementation
timeFrame: Across 8-week intervention period
measure: Recruitment of target sample size
timeFrame: Across 8-week intervention period
measure: Enrollment of percent eligible
timeFrame: Across 8-week intervention period
measure: Retention to interventions
timeFrame: Across 8-week intervention period
Secondary outcomes:
measure: Feasibility of implementation
timeFrame: Across 8-week intervention period
measure: Acceptability of interventions
timeFrame: Across 8-week intervention period
Other outcomes:
measure: Mindfulness, self-reported
timeFrame: Up to 3 months of follow-up
measure: Mindfulness, observed
timeFrame: Up to 3 months of follow-up
measure: Self-compassion, self-reported
timeFrame: Up to 3 months of follow-up
measure: Adolescent reports of emotion regulation
timeFrame: Up to 3 months of follow-up
measure: Anxiety
timeFrame: Up to 3 months of follow-up
measure: Cortisol stress reactivity
timeFrame: Up to 3 months of follow-up
measure: Cardiovascular stress reactivity
timeFrame: Up to 3 months of follow-up
measure: Diurnal cortisol production
timeFrame: Up to 3 months of follow-up
Locations:
city: Fort Collins
country: United States
facility: Colorado State University
state: Colorado
Study officials:
References:
citation: Lucas-Thompson R, Seiter N, Broderick PC, Coatsworth JD, Henry KL, McKernan CJ, Smyth JM. Moving 2 Mindful (M2M) study protocol: testing a mindfulness group plus ecological momentary intervention to decrease stress and anxiety in adolescents from high-conflict homes with a mixed-method longitudinal design. BMJ Open. 2019 Nov 28;9(11):e030948. doi: 10.1136/bmjopen-2019-030948.