Formal Versus Informal Mindful Self-Compassion Programming for Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 135
- 试验地点
- 1
- 主要终点
- Coping Index (CI)
研究概览
简要总结
The goal of this clinical trial is to learn if two types of mindful self-compassion programs work to improve coping in adolescents. The investigators will also learn about adolescents' liking of, and the other potential mental health and academic benefits of, these programs. The main questions this clinical trial aims to answer are:
- Do two types of mindful self-compassion programs improve coping in adolescents?
- Do two types of mindful self-compassion programs improve mental health (e.g., stress, anxiety, depression) and academic outcomes (e.g., academic engagement) in adolescents?
- How satisfactory are two types of mindful self-compassion programs for adolescents?
To do this, the investigators will compare adolescents who complete two types of mindful self-compassion programs to adolescents in a "waitlist control" condition (who complete no study tasks during the program period, but will have the opportunity to complete the program at the end of the study).
Participants will:
- Complete a brief phone interview to confirm their eligibility (15 min)
- Complete an online survey including questions about coping, mental health, and academic engagement (30 min)
- Complete a live, online, four-week-long mindful self-compassion program OR no study tasks during this four-week period (if randomly assigned to a waitlist condition)
- Complete an online survey 1 week after the 4-week period, including questions about coping, mental health, and academic engagement, as well as their liking of the program they completed (if applicable)
- Complete an online survey 1 month after the 4-week period, including questions about coping, mental health, and academic engagement
- (Waitlist condition only) Have the opportunity to complete one of the two mindful self-compassion programs after the study had ended
详细描述
Background
Over the past decade, increasing smartphone and social media usage have magnified social pressures among adolescents. In turn, these youth report heightened stress and self-criticism, and often turn to unhealthy coping behaviors (e.g., substance use, disordered eating, self-injury) that can become life-threatening, making this a critical issue in youth mental health. Emerging evidence suggests that group-based mindful self-compassion (MSC) interventions may improve adolescents' mental health and encourage their use of healthy coping behaviors. However, challenges persist regarding adherence to standard length (i.e., eight-week) programs and low engagement with formal mindfulness practice (e.g., meditation) among adolescents; briefer programs and a focus on informal practice may be better tolerated and more effective. The aims of the proposed hybrid 1 effectiveness-implementation randomized clinical trial (RCT) are thus to compare the effectiveness and acceptability of four-week-long formal (MSC-F) versus informal (MSC-I) MSC interventions for adolescents, relative to a waitlist control condition.
Procedure
Prior to administering a screening questionnaire, the project director (PD; Julia Petrovic) will contact the prospective participant's parent by phone (or the participant directly if 18-19 years old) to describe the study and conduct a pre-screen with inclusion/exclusion criteria. If the adolescent is deemed to be potentially eligible, a call will be scheduled with the applicant, parent (if required), and adolescent to review and sign the informed consent/assent forms together over the phone or a Zoom/Google Meet HIPAA-compliant videoconference call. After informed consent/assent have been obtained, adolescents will complete a brief phone interview to confirm their eligibility.
Eligible adolescents will then be randomized, stratified by gender, to one of three trial arms with a 1:1:1 allocation ratio: MSC-F, MSC-I, or waitlist control. The PD will conduct the randomization and inform participants and their parents (if <18 years) of their assigned condition via email (as well as share group session scheduling information if assigned to the MSC-F or MSC-I conditions). Shortly after this email has been sent, the PD will call the parents/participants to ensure that the information was received and confirm the scheduled MSC group session dates/times.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Be 14-19 years of age for the duration of the study;
- •If 14-17 years of age: have a parent with sufficient literacy skills to understand the consent process and have the ability to provide written informed consent, and have sufficient English fluency and literacy skills themselves to understand the assent process, procedures, and questionnaires and have the ability to provide written assent;
- •If 18-19 years of age: have sufficient English fluency and literacy skills themselves to understand the consent process, procedures, and questionnaires and have the ability to provide written informed consent;
- •Have access to the internet and an electronic device with adequate data capacity to complete questionnaires online and attend online videoconference groups;
- •Be available and willing to attend the scheduled online videoconference groups for 4 weeks and complete the online assessments.
排除标准
- •Current or past-year treatment with mindfulness-based psychotherapy (e.g., MBCT, DBT, or ACT);
- •Current or past-year participation in a mindfulness- or compassion-based program;
- •A routine of, on average, 10 minutes of mindfulness practice per day over the past 30 days (greater than or equal to 300 minutes);
- •Simultaneous participation in another experimental research study;
- •Current or past-year diagnosis of: schizophrenia spectrum or other psychotic disorder, bipolar 1 disorder, or severe substance/alcohol use disorder;
- •Current or past-month suicidal ideation;
- •Hospitalization for reasons related to mental health within the past 6 months;
- •Recent modifications to psychiatric medication(s) (within the last 30 days or within the last 90 days for antidepressants (e.g., SSRI, SNRI, etc.);
- •Inability to complete consent/assent process or baseline assessment.
研究组 & 干预措施
Formal Mindful Self-Compassion (MSC-F)
Participants assigned to the MSC-F condition (n=45) will complete a four-week-long live online mindful self-compassion program, which will include the instruction of formal practices (e.g., guided meditations).
干预措施: Formal Mindful Self-Compassion (MSC-F) (Behavioral)
Informal Mindful Self-Compassion (MSC-I)
Participants assigned to the MSC-I condition (n=45) will complete a four-week-long live online mindful self-compassion program, which will include the instruction of informal practices (e.g., noticing day-to-day sensory experiences with mindful self-compassion).
干预措施: Informal Mindful Self-Compassion (MSC-I) (Behavioral)
Waitlist Control
Participants assigned to the waitlist control condition (n=45) will complete no study tasks during the 4-week intervention period, during which participants assigned to the MSC-F and MSC-I conditions complete their assigned programs. These waitlist control participants will be invited to complete one of the two programs at the end of the 9-week study period.
结局指标
主要结局
Coping Index (CI)
时间窗: 5 weeks (From baseline to 1 week post-intervention)
The Coping Index (CI; Stallman, 2017) is a 20-item self-report measure of healthy (10 items) and unhealthy (10 items) coping behaviors based on the Health Theory of Coping (Stallman, 2020). Respondents rate how often they use each behavior to feel better when they are feeling stressed or distressed using a 4-point Likert scale ranging from I do not do this at all (0) to I do this most of the time (3). The item, 'Have thoughts about suicide', will be omitted for the purposes of this study; an adapted 19-item version of the CI will therefore be used. A coping index score will be computed, which is the healthy subscale mean minus the unhealthy subscale mean (possible range: 3 to -3). A higher score reflects a better outcome.
次要结局
- Coping Index (CI)(9 weeks (From baseline to 1 month post-intervention))
- 18-item Five Facets of Mindfulness Questionnaire (FFMQ-18)(5 weeks and 9 weeks (From baseline to 1 week and 1 month post-intervention))
- Self-Compassion Scale - Short Form (SCS-SF)(5 weeks and 9 weeks (From baseline to 1 week and 1 month post-intervention))
- Perceived Stress Scale (PSS)(5 weeks and 9 weeks (From baseline to 1 week and 1 month post-intervention))
- Generalized Anxiety Disorder (GAD-7) scale(5 weeks and 9 weeks (From baseline to 1 week and 1 month post-intervention))
- Patient Health Questionnaire - Modified for Adolescents (PHQ-A)(5 weeks and 9 weeks (From baseline to 1 week and 1 month post-intervention))
- Theoretical Framework of Acceptability (TFA) questionnaire(5 weeks (From baseline to 1 week post-intervention))