Trials / Completed
CompletedNCT05760443
Mental Health Intervention Research in At-Risk Adolescents
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 74 (actual)
- Sponsor
- Colorado State University · Academic / Other
- Sex
- All
- Age
- 12 Years – 18 Years
- Healthy volunteers
- Accepted
Summary
The goal of the proposed research is to support adolescent health through providing inclusive evidence-based programming that is in line with community needs. Specifically, the investigators aim to: 1) investigate the effects of mindfulness-based intervention (MBI) on adolescent mental health, 2) identify underlying mechanisms (e.g., engagement, stress physiology, emotion regulation) of MBI for adolescent health and wellbeing 3) identify facilitators and barriers of engagement in MBI for community adolescents.
Detailed description
Experiencing mental health problems during adolescence is associated with symptom worsening and recurrence later in life, as well as poorer physical health and increased risk for preventable chronic diseases. Mindfulness-based intervention (MBI) has been shown to support key skills and capacities that may protect against mental health challenges, including emotion regulation and stress physiology. Yet, MBI effects on health and wellbeing outcomes in adolescents are generally small and inconsistent across studies. This research will provide an opportunity for testing MBI in community adolescent samples, with a focus on clarifying underlying mechanisms and understanding subjective facilitators and barriers to engagement in MBI is critical. In research with adolescents, L2B has been associated with improvements in emotion regulation and indicators of mental and physical wellbeing. In our previous work, the investigators delivered L2B as part of a broader healthy lifestyle program for families, and it was feasible and acceptable to adolescent participants. Delivering L2B is also consistent with the results of the 2020 Larimer County Needs Assessment, in which 48% of respondents indicated a need for more resources to support mental health and stress management for youth. Thus, given the solid evidence base for the benefits of L2B for adolescents, our experience delivering L2B to Northern Colorado teens in a previous phase of this community-engaged work, and the identified community need for inclusive, evidence-based mental health prevention programming for adolescents, the investigators will begin delivering L2B and evaluating the program's benefits on adolescent health and wellbeing. The capacity of mindfulness, or present-centered, nonjudgmental attention, has also been associated with fewer mental health concerns in adolescents. However, meta-analyses and recent large-scale randomized controlled trials indicate that MBI does not always produce the desired outcomes in adolescents. This heterogeneity of findings indicates the need for mechanistic studies that closely examine the processes occurring during and between intervention sessions. This project both addresses an identified community need (inclusive mental health programming for adolescents) and will advance our understanding of the mechanisms that underlie MBI efficacy for supporting youth mental health in nonclinical samples. This study will be a single-arm trial of an MBI utilizing a repeated measures assessment design. The single-arm nature keeps the project aligned with our goal of meeting community needs, and the multiple assessment timepoints (baseline, weekly across the 6-week intervention, follow-up) allows us to examine temporal ordering of changes in hypothesized mechanisms. With this project the investigators seek to elucidate the underlying mechanisms of mindfulness-based intervention effectiveness for adolescent health.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Learning to BREATHE | Learning 2 BREATHE (L2B) is an empirically-supported, manualized mindfulness-based group program (Broderick, 2021). Participants attend 6 sessions of approximately 1.5 hours per session. "BREATHE" is an acronym: Body, Reflections, Emotions, Attention, Tenderness, Habits, Empowerment; each week's lesson is centered around one of the letters (week 1 encompasses both Body and the overall theme of the sessions, Empowerment). Sample activities of L2B include psycho-education on emotion and self-regulation, body scanning, sitting meditation, non-aerobic yoga, and walking meditation, designed to promote moment-to-moment awareness of mind-body experiences. In between sessions, participants are encouraged to practice brief mindfulness skills in their daily lives and to complete the "homework" assignments, such as an audio-guided body scan. Participants will have access to home-practice audio-recordings and will be queried about their completion of home-practice assignments. |
Timeline
- Start date
- 2023-05-15
- Primary completion
- 2024-10-01
- Completion
- 2025-05-01
- First posted
- 2023-03-08
- Last updated
- 2025-05-18
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT05760443. Inclusion in this directory is not an endorsement.