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
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. The duration of the study period for participants in all three trial arms is 9 weeks. All participants will complete a 30-minute survey battery (baseline/Week 0). Participants in the MSC-F and MSC-I conditions will then complete their assigned interventions over the course of four weeks (Weeks 1-4) while those in the waitlist control condition do not complete any study tasks. Participants in the MSC-F and MSC-I conditions will also complete weekly home practice surveys from Weeks 2-5 (i.e., one following each week of the program). Participants in all three study arms will then complete a 30-minute survey battery 1 week (Week 5) and 1 month (Week 8) after the intervention period. At the end of the study period, participants assigned to the waitlist control condition will be invited to complete one of the two MSC interventions. All study procedures will be conducted virtually through phone/email, videoconference, and the secure REDCap survey platform.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
135
The MSC-F and MSC-I programs will be adaptations of the Mindful Self-Compassion - Teen (MSC-T) program (formerly Making Friends With Yourself; Bluth et al., 2016). MSC-T includes the instruction of both formal and informal practices; the adapted programs will thus disentangle the two approaches to allow for their direct comparison. The adapted MSC-F and MSC-I programs will comprise weekly hour-long virtual group sessions held over four weeks and led in real time by IRB-approved CHA researchers and clinicians. Each session will include (i) psychoeducation related to stress, mindfulness, self-compassion, and healthy/unhealthy coping, (ii) in-session mindfulness practice, and (iii) group discussion. Content will be identical across the MSC-F and MSC-I programs aside from the specific practices taught (i.e., whether exclusively formal or informal). Weekly home practice will be assigned and supporting handouts and audio files (where applicable) will be shared following each session.
The MSC-F and MSC-I programs will be adaptations of the Mindful Self-Compassion - Teen (MSC-T) program (formerly Making Friends With Yourself; Bluth et al., 2016). MSC-T includes the instruction of both formal and informal practices; the adapted programs will thus disentangle the two approaches to allow for their direct comparison. The adapted MSC-F and MSC-I programs will comprise weekly hour-long virtual group sessions held over four weeks and led in real time by IRB-approved CHA researchers and clinicians. Each session will include (i) psychoeducation related to stress, mindfulness, self-compassion, and healthy/unhealthy coping, (ii) in-session mindfulness practice, and (iii) group discussion. Content will be identical across the MSC-F and MSC-I programs aside from the specific practices taught (i.e., whether exclusively formal or informal). Weekly home practice will be assigned and supporting handouts and audio files (where applicable) will be shared following each session.
Center for Mindfulness and Compassion
Malden, Massachusetts, United States
RECRUITINGCoping Index (CI)
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.
Time frame: 5 weeks (From baseline to 1 week post-intervention)
Coping Index (CI)
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.
Time frame: 9 weeks (From baseline to 1 month post-intervention)
18-item Five Facets of Mindfulness Questionnaire (FFMQ-18)
The 18-item Five Facets of Mindfulness Questionnaire (FFMQ-18; Medvedev et al., 2018) is a self-report measure of dispositional (i.e., trait) mindfulness. It consists of five subscales, each reflecting one facet of mindfulness (acting with awareness, nonjudgmental acceptance, nonreactivity, observing, and describing). Items are rated on a 5-point Likert scale ranging from Never or very rarely true (1) to Very often or always true (5). The FFMQ-18 is the most reliable and valid short form of the full-scale (39-item) FFMQ (Medvedev et al., 2018). A global mean will be computed (possible range: 1 to 5) whereby a higher score reflects a better outcome.
Time frame: 5 weeks and 9 weeks (From baseline to 1 week and 1 month post-intervention)
Self-Compassion Scale - Short Form (SCS-SF)
The Self-Compassion Scale - Short Form (SCS-SF; Raes et al., 2011) is a 12-item self-report measure of self-compassion. Respondents are asked to indicate how often they behave in the stated manner using a 5-point Likert scale ranging from Almost never (1) to Almost always (5). The SCS-SF has a near-perfect correlation with the full-scale SCS and is a reliable alternative when assessing overall self-compassion (Raes et al., 2011). A global mean will be computed (possible range: 1 to 5) whereby a higher score reflects a better outcome.
Time frame: 5 weeks and 9 weeks (From baseline to 1 week and 1 month post-intervention)
Perceived Stress Scale (PSS)
The Perceived Stress Scale (PSS; Cohen et al., 1983) is a 10-item self-report measure of perceived stress. Respondents are asked to rate each item on a 5-point Likert scale (0 = Never to 4 = Very often) based on how often they feel or think a certain away. A sum score will be computed (possible range: 0 to 40) whereby a higher score reflects a worse outcome.
Time frame: 5 weeks and 9 weeks (From baseline to 1 week and 1 month post-intervention)
Generalized Anxiety Disorder (GAD-7) scale
The Generalized Anxiety Disorder scale (GAD-7; Spitzer et al., 2006) is a widely used 7-item self-report measure of anxiety. Respondents are prompted to indicate using a 4-point Likert scale ranging from Not at all (0) to Nearly every day (3) how often they experienced each anxiety symptom listed over the past two weeks. A sum score will be computed (possible range: 0 to 21) whereby a higher score reflects a worse outcome.
Time frame: 5 weeks and 9 weeks (From baseline to 1 week and 1 month post-intervention)
Patient Health Questionnaire - Modified for Adolescents (PHQ-A)
The Patient Health Questionnaire - Modified for Adolescents (PHQ-A; Johnson, 2002) is a 9-item self-report measure of depression for adolescents, adapted from the widely-used adult version. Respondents are asked to indicate how often they experienced each depressive symptom listed over the past two weeks using a 4-point Likert scale ranging from Not at all (0) to Nearly every day (3). The item, 'Thoughts that you would be better off dead, or of hurting yourself in some way?', will be omitted for the purposes of this study; an adapted 8-item version of the PHQ-A will therefore be used. A sum score will be computed (possible range: 0 to 24) whereby a higher score reflects a worse outcome.
Time frame: 5 weeks and 9 weeks (From baseline to 1 week and 1 month post-intervention)
Theoretical Framework of Acceptability (TFA) questionnaire
The Theoretical Framework of Acceptability questionnaire (TFA; Sekhon et al., 2022) is an 8-item self-report measure of intervention acceptability that will only be administered 1-week post-intervention to those in the MSC-F and MSC-I conditions. The TFA questionnaire is adaptable and can be used to evaluate a variety of healthcare interventions (including mental healthcare). It consists of seven items, each pertaining to one of the components listed above, as well as an eighth item that assesses general acceptability. Items are rated on 5-point Likert scales (with varying labels depending on the item). A global mean will be computed (possible range: 1 to 5) whereby a higher score reflects a better outcome. In addition, 5 researcher-developed, follow-up open-ended questions will be asked at the end of the TFA to obtain more detailed information regarding intervention acceptability (e.g., What did you like the most about the program?).
Time frame: 5 weeks (From baseline to 1 week post-intervention)
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