Clinical trial NCT05760443: Mental Health Intervention Research in At-Risk Adolescents
Official title: Mental Health Intervention Research in At-Risk Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Health Wellness 1
Lead sponsor: Colorado State University
Sponsor class: OTHER
First posted: 2023-03-08
Enrollment: 74
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: Inclusion Criteria:

1) between the ages of 12-18 years old,

- 2) Reside in Larimer County or the surrounding area.

Exclusion Criteria:

* Adolescents will not take part in the program if they demonstrate active suicidal ideation and/or behavior.
* Adolescents will not take part in the program and/or research activities if they have a medical and/or psychological/behavioral condition that, in the opinion of the research team, could interfere with safety for themselves or others or interfere with the capability of the youth or other participants to potentially benefit from the program (e.g., severe emotional-behavioral disturbance, inability to follow facilitator directions) .

Primary outcomes:
measure: Emotion Regulation - Adolescent Report
timeFrame: 6 weeks
measure: Emotion Regulation - Parent Report
timeFrame: 6 weeks
measure: Mindfulness - Attention
timeFrame: 6 weeks
measure: Mindfulness - Self Compassion
timeFrame: 6 weeks
measure: Mindfulness - Behavioral Task
timeFrame: 6 weeks
measure: Stress Reactivity - Respiratory Sinus Arrythmia
timeFrame: 6 weeks
measure: Stress Reactivity - Skin Conductance
timeFrame: 6 weeks
measure: Stress Reactivity - Heart Rate
timeFrame: 6 weeks
measure: Stress Reactivity - Blood Pressure
timeFrame: 6 weeks
measure: Mental health - Anxiety
timeFrame: 6 weeks
measure: Mental health - Depression
timeFrame: 6 weeks
Secondary outcomes:
measure: Compassion for others
timeFrame: 6 weeks
measure: Stress appraisal
timeFrame: 6 weeks
measure: Social Media Use
timeFrame: 6 weeks
measure: Eating behavior
timeFrame: 6 weeks
measure: Objectified Body Consciousness
timeFrame: 6 weeks
measure: Intervention liking and acceptability
timeFrame: 6 week follow up only
measure: Engagement - Cognitive Behavioral
timeFrame: 6 weeks
measure: Engagement - Value
timeFrame: 6 weeks
measure: Engagement - Interest
timeFrame: 6 weeks
measure: Engagement - Teacher and Classmate Support
timeFrame: 6 weeks
measure: Engagement - Mindfulness
timeFrame: 6 weeks
measure: Engagement - Observational
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Fort Collins
country: United States
facility: Colorado State University
state: Colorado
Study officials:
affiliation: Colorado State University
name: Lauren Shomaker, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: