Meditation App for Emotion Regulation in Youth on Probation

(ProjectAIM Trial)

Overseen By Ashley D Kendall, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Illinois at Chicago

Disqualifiers: Non-English speakers, Detained, DCFS care, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how effectively a meditation app can help young people on probation manage their emotions. It also assesses the feasibility of collecting data on cannabis use, sexual health, and mental health from participants over time. Participants will use either the Bodhi AIM meditation app or a health promotion app called HIB (Haemophilus influenzae type b vaccine). Eligible participants should be between 13-18 years old, currently in probation programs in Cook County, IL, and have access to a smartphone. As an unphased trial, this study offers participants a unique opportunity to contribute to innovative research that could positively impact their emotional well-being.

Do I have to stop taking my current medications to join the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that meditation apps, such as Bodhi AIM, are generally safe for users. Previous studies with similar apps found that people usually enjoy using them and report no serious issues or side effects. Since this trial involves a meditation app, a non-invasive and low-risk activity, it is expected to be safe for participants. Studies with similar apps have reported no negative events. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional therapeutic approaches for emotion regulation in youth on probation, which often involve in-person counseling or medication, the Bodhi AIM meditation app provides a digital, self-guided way to practice mindfulness and emotional control. This app leverages technology to make meditation accessible anytime and anywhere, offering a flexible and non-invasive option. Researchers are excited about Bodhi AIM because it empowers youth to independently manage their emotions, potentially leading to improved outcomes in a population that may face barriers to conventional treatment methods.

What evidence suggests that this trial's treatments could be effective for emotion regulation in youth on probation?

Research shows that mindfulness and meditation can greatly help people manage their emotions. One study demonstrated that a 5-week mindfulness program for teenagers with mental health issues led to less stress and better emotional control. In this trial, participants in the experimental arm will use the Bodhi AIM meditation app, which past studies have shown helps users manage their emotions more effectively. This suggests that the app could help young people in the juvenile legal system handle stress and emotions better. ^{1 2 3 6 7}

Who Is on the Research Team?

Ashley D Kendall, PhD

Principal Investigator

University of Illinois at Chicago

Are You a Good Fit for This Trial?

This trial is for justice-involved youth aged 13-18 on probation in Chicago's Cook County. Participants must understand consent procedures, speak English, have a legal guardian's permission if under 18, agree to participate, and own an Apple or Android phone. Those detained or in DCFS care are excluded.

Inclusion Criteria

On probation in the Chicago Cook County Juvenile Justice System

Exclusion Criteria

Are in care of DCFS

Unable to understand the permission/consent/assent process

I am currently detained.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete a baseline questionnaire before randomization

1 day

1 visit (in-person or virtual)

Intervention

Participants use either the Bodhi AIM mindfulness app or the HIB health promotion app for 30 days

4 weeks

Follow-up

Participants are monitored for changes in behavior and mental health at 1-month and 6-month follow-ups

6 months

2 visits (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Bodhi AIM
• HIB

Trial Overview The study compares two groups: one uses the Bodhi AIM meditation app (intervention group) and the other does not (control group). It aims to see if the app helps with emotion control and reduces risky behaviors related to HIV/STI like alcohol/cannabis use, sexual activity, and aggression.

How Is the Trial Designed?

Group I: Bodhi AIM Experimental Treatment 1 Intervention

Participants randomized to the intervention arm will receive the Bodhi AIM meditation app.

Group II: HIB Active Control 1 Intervention

Participants randomized to the active control arm will receive the HIB health promotion app.

Who Is Running the Clinical Trial?

University of Illinois at Chicago

Lead Sponsor

Trials

653

Recruited

1,574,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Published Research Related to This Trial

The study evaluated the feasibility of Thai Buddhism-based Mindfulness (TBbM) for pain management in a randomized controlled trial with 17 participants, but faced challenges with recruitment and retention, as 82% of eligible participants declined to join.

While the TBbM intervention did not show statistically significant improvements in pain severity compared to the control group, there was a moderate effect size indicating potential benefits, suggesting that further research with a larger sample size is needed to confirm its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Thai Buddhism-Based Mindfulness for Pain Management in Thai Outpatients with Cancer: A Pilot Study. Ngamkham, S., Yang, JJ., Smith, EL.[2023]

In a 21-day mindfulness-based intervention with 82 participants, 87% reported at least one momentary adverse effect during meditation, primarily anxiety, indicating that mindfulness practice can sometimes lead to temporary increases in anxiety.

Despite these momentary effects, 25% of participants experienced sustained adverse effects in daily life after the intervention, but these were not linked to the momentary effects during meditation, suggesting that increased awareness of internal states may contribute to these post-intervention challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First, do no harm: An intensive experience sampling study of adverse effects to mindfulness training. Aizik-Reebs, A., Shoham, A., Bernstein, A.[2021]

A 5-week mindfulness-based intervention for adolescents with psychiatric disorders led to significant decreases in psychological distress and increases in mindfulness and self-esteem, indicating its potential effectiveness.

Both adolescents and their parents reported improvements in functioning, suggesting that the intervention is not only feasible and acceptable but also beneficial for mental health, warranting further research in a randomized controlled study.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Taming the adolescent mind: preliminary report of a mindfulness-based psychological intervention for adolescents with clinical heterogeneous mental health diagnoses. Tan, L., Martin, G.[2022]

Mindfulness-Based Interventions (MBIs) showed small but significant treatment effects in youth, with a meta-analysis of 76 studies involving 6121 participants indicating an effect size of g=0.305 for pre-post designs and g=0.322 for controlled designs.

The effectiveness of MBIs appeared to increase over time, with follow-up assessments showing larger effects (g=0.462 for pre-post and g=0.402 for controlled designs), suggesting that the benefits of mindfulness practices may continue to grow after the intervention ends.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based interventions with youth: A comprehensive meta-analysis of group-design studies. Klingbeil, DA., Renshaw, TL., Willenbrink, JB., et al.[2018]

A mindfulness-based stress reduction (MBSR) program for HIV-infected and at-risk urban youth showed significant reductions in hostility, general discomfort, and emotional discomfort after nine weekly sessions, with 79% of participants completing the program.

Qualitative feedback from participants indicated improvements in interpersonal relationships, school achievement, and physical health, suggesting that MBSR may positively impact various aspects of life for these youth, although further controlled studies are needed to confirm these effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based stress reduction for urban youth. Sibinga, EM., Kerrigan, D., Stewart, M., et al.[2022]

The mindfulness-based relapse prevention for alcohol dependence (MBRP-A) did not show significant improvements in drinking outcomes compared to usual care alone in a study of 123 alcohol-dependent adults over 26 weeks.

However, participants who attended more MBRP-A sessions and practiced mindfulness techniques at home tended to have better long-term drinking-related outcomes, suggesting that adherence to the intervention may be beneficial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based relapse prevention for alcohol dependence: Findings from a randomized controlled trial. Zgierska, AE., Burzinski, CA., Mundt, MP., et al.[2020]

A mindfulness-based intervention combined with standard outpatient treatment significantly reduced symptoms of depression, anxiety, and anger expression in participants over three months, with 22 individuals in the experimental group and 20 in the control group.

Despite improvements in mental health symptoms, the intervention did not show a significant effect on substance use behavior, indicating the need for further research to explore its overall impact.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The contribution of mindfulness to outpatient substance use disorder treatment in Brazil: a preliminary study. Machado, MP., Fidalgo, TM., Brasiliano, S., et al.[2021]

A trauma-informed, mindfulness-based yoga (TIMBY) intervention was successfully adapted for youth in the Georgia Department of Juvenile Justice, with modifications made to ensure it was suitable for this specific population.

In a pilot study involving 30 youth participants, the majority reported high satisfaction and positive impacts on their physical and emotional challenges, indicating the potential effectiveness of the adapted TIMBY protocol in a justice setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Pilot Study to Adapt a Trauma-Informed, Mindfulness-Based Yoga Intervention for Justice-Involved Youth. Owen-Smith, A., Black, H., Emerson, D., et al.[2022]

The study explored the feasibility of an Acceptance and Commitment Therapy (ACT)-based prevention program for anxiety and depression among 48 high school students, showing that the program was acceptable and could be effectively implemented in a school setting.

While no statistically significant differences were found between the ACT intervention and usual classes, the effect sizes indicated potential benefits of the ACT program, suggesting it could be a promising approach for preventing anxiety and depression in young people and warrants further research with a larger sample.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptance and commitment therapy universal prevention program for adolescents: a feasibility study. Burckhardt, R., Manicavasagar, V., Batterham, PJ., et al.[2020]

The mindfulness-based stress reduction (MBSR) program, adapted for individuals with mild traumatic brain injury (mTBI), showed clinically meaningful improvements in quality of life and perceived self-efficacy after a 10-week intervention involving 22 participants.

Participants experienced enhanced awareness and acceptance of their symptoms, which may help reduce the negative impact of mTBI on their daily lives, suggesting that MBSR could be a beneficial therapeutic approach for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot study examining the effect of mindfulness-based stress reduction on symptoms of chronic mild traumatic brain injury/postconcussive syndrome. Azulay, J., Smart, CM., Mott, T., et al.[2019]

Mindfulness-based interventions show some promise in improving mental health and self-regulation among youth offenders, with 842 participants aged 14 to 23, but the studies varied widely in their approaches, making it hard to determine the best method.

Qualitative feedback from participants indicated benefits such as reduced stress and improved emotional management, although the overall quality of the studies was low, which limits the reliability of these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-Based Interventions for Young Offenders: a Scoping Review. Simpson, S., Mercer, S., Simpson, R., et al.[2023]

Meditation can significantly enhance emotion and attention regulation, with studies showing positive effects in various age groups, including undergraduates and children, after just 5 days of practice.

Neuroimaging studies indicate that meditation improves brain activation and connectivity in areas associated with self-regulation, suggesting its potential for helping with mental disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meditation improves self-regulation over the life span. Tang, YY., Posner, MI., Rothbart, MK.[2021]

The study focused on teaching mindfulness to 10 incarcerated adolescents with substance use issues, highlighting the need for tailored approaches in this specific population.

Using a grounded theory approach over a year, the research aimed to develop effective methods for teaching mindfulness, indicating a significant gap in existing literature on this topic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness training as an intervention for substance user incarcerated adolescents: a pilot grounded theory study. Himelstein, S., Saul, S., Garcia-Romeu, A., et al.[2016]

Adolescents in the juvenile justice system experience higher rates of trauma, which can lead to serious mental and physical health issues, as well as increased chances of reoffending.

Mindfulness meditation is proposed as a beneficial adjunctive treatment that could support healthy brain development and promote prosocial behavior in these youths, suggesting it should be integrated into rehabilitation programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness and meditation as an adjunctive treatment for adolescents involved in the juvenile justice system: Is repairing the brain and nervous system possible? Winters, DE., Beerbower, E.[2018]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06997120

Testing the Effectiveness and Implementation of a Meditation ... The goals of this hybrid type 2 randomized controlled trial (RCT) are to evaluate the effectiveness and individual-level implementation of a 1-month ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12062756/

Feasibility Testing a Meditation App for Professionals Working ... This paper describes the protocol for a hybrid type 2 effectiveness-implementation pilot randomized controlled trial (RCT) of Bodhi AIM+, a meditation app ...

3. withpower.com withpower.com/trial/phase-aggression-11-2021-2a5db

Meditation App for Emotion Regulation in Youth on Probation · ... A 5-week mindfulness-based intervention for adolescents with psychiatric disorders led to significant decreases in psychological distress and increases in ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05146167

Feasibility Testing a Meditation App for Youth in the Legal ... Participants randomized to the intervention arm will receive the Bodhi AIM meditation app. Intervention/Treatment, Behavioral : Bodhi AIM (intervention group).

5. reporter.nih.gov reporter.nih.gov/search/Mv2uy7kjVk2O7SoZEvjHgw/project-details/11019005

kendall, ashley d. - NIH RePORTER First, we will leverage our successful pilot RCT design to run a hybrid type 2 effectiveness-implementation RCT with N=300 youth on probation in Cook County.

6. reporter.nih.gov reporter.nih.gov/project-details/11192266

Effectiveness and Implementation of a Meditation App ... Throughout the pilot RCT, youth and officers requested that the meditation app be sustained in probation programming if it demonstrates effectiveness. This ...

7. researchgate.net researchgate.net/publication/391121169_Feasibility_Testing_a_Meditation_App_for_Professionals_Working_With_Youth_in_the_Legal_System_Protocol_for_a_Hybrid_Type_2_Effectiveness-Implementation_Pilot_Randomized_Controlled_Trial

Feasibility Testing a Meditation App for Professionals ... Background Probation officers and other professionals who work with youth in the legal system often experience high chronic workplace stress, ...