Anxiety, Stress
Conditions
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.
Interventions
BEHAVIORALLearning to BREATHE Plus
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.
BEHAVIORALHealth and wellness
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.
Sponsors
National Center for Complementary and Integrative Health (NCCIH)
Colorado State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
The majority of study personnel, including the PI and study statistician, will be blinded until database lock. All individuals who will be involved with endpoint assessment will be blinded until database lock. Intervention facilitators will not be blinded, but will not be involved in endpoint assessment.
Intervention model description
Participants will be assigned to one of two study interventions in an open randomized trial.
Eligibility
Sex/Gender
ALL
Age
14 Years to 18 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Cortisol stress reactivity | Up to 3 months of follow-up | Cortisol reactivity to a stressor (saliva samples after baseline and immediately as well as 10 and 20m after stressor); area under the curve will be calculated |
| Cardiovascular stress reactivity | Up to 3 months of follow-up | Adolescent cardiovascular reactivity to a stressor (across three minutes intervals at baseline and during the stressor); change from baseline to stressor will be calculated |
| Diurnal cortisol production | Up to 3 months of follow-up | Cortisol production across the day (participants will be asked to provide samples upon awakening, 30 minutes after waking, at 4:00 PM, and before brushing their teeth for bed) to calculate cortisol awakening responses and decreases in cortisol production from morning to evening |
| Mindfulness, self-reported | Up to 3 months of follow-up | Adolescents reported mindfulness (Mindfulness Awareness and Attention Scale, Adolescent Version; Brown, West, Loverich, & Biegel, 2011). There are 14 items on this scale, each answered on a scale from 1 (almost always) to 6 (almost never). Answer across 14 items are averaged such that higher scores indicate higher trait mindfulness (minimum = 1; maximum = 6). |
| Mindfulness, observed | Up to 3 months of follow-up | Adolescents observed distress tolerance, an important component of mindfulness (Behavioral Indicator of Resiliency to Distress; Lejeuz et al., 2006) |
| Self-compassion, self-reported | Up to 3 months of follow-up | Self-Compassion Scale, short form (Raes, Pommier, Neff, & Van Gucht, 2011). This scale has 12 items, answered on a scale from 1 (almost never) to 5 (almost always). There are 6 subscales measured on this scale, each with 2 items: self-kindness, self-judgment, common humanity, isolation, mindfulness, and over-identification. Subscale and total scores are calculated based on means after reverse scoring so that high scores indicate higher self-compassion (minimum: 1; maximum: 5). |
| Adolescent reports of emotion regulation | Up to 3 months of follow-up | Emotion regulation (Difficulties in Emotion Regulation Scale; Gratz & Roemer, 2004). This scale has 36 items that measure difficulties in 6 sub-dimensions of emotion regulation: nonacceptance of emotional responses (6 items: minimum: 1; maximum: 36), difficulties engaging in goal-directed behavior (5 items: minimum: 1; maximum: 30), impulse control difficulties (6 items: minimum: 1; maximum: 36), lack of emotional awareness (6 items: minimum: 1; maximum: 36), limited access to emotion regulation strategies (8 items: minimum: 1, maximum 48), and lack of emotional clarity (5 items: minimum: 1; maximum: 30). Questions are answered on a scale from 1 (almost never) to 5 (almost always). Subscale and total scores are summed such that higher scores indicate greater difficulties with emotion regulation (total scores: minimum: 1, maximum: 180). |
| Anxiety | Up to 3 months of follow-up | Parent and adolescent reported youth anxiety (Revised Child Anxiety and Depression Scale; Chorpita, Yim, Moffitt, Umemoto, & Francis, 2000). This scale has 47 items answered on a scale from 0 (never) to 3 (always), and answers are summed. Total scores range from 0 to 141, with higher scores reflecting more symptoms of anxiety and depression. Subscales can also be used to calculate scores for separation anxiety (7 items; minimum: 0, maximum: 21), social anxiety (9 items; minimum: 0, maximum 27), obsessive/compulsions (6 items; minimum: 0, maximum: 18), panic/agoraphobia (9 items; minimum: 0, maximum: 27), generalized anxiety (6 items; minimum: 0, maximum: 18), and major depression (10 items; minimum: 0, maximum: 30), with higher scores reflecting more symptoms. |
Countries
United States
Outcome results
None listed