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

107 Participants Needed

Trial Summary

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.

What data supports the idea that Meditation App for Emotion Regulation in Youth on Probation is an effective treatment?

The available research shows that mindfulness-based interventions, like the Meditation App for Emotion Regulation, can help adolescents with mental health issues. One study found that these interventions improved mental health outcomes and reduced psychological distress in adolescents with psychiatric disorders. Another study highlighted that mindfulness training helped incarcerated adolescents with substance use issues, suggesting it could be effective for youth on probation. Additionally, mindfulness meditation is suggested to aid in brain development and promote positive behavior in adolescents involved in the juvenile justice system. These findings indicate that the Meditation App could be a beneficial treatment for youth on probation. ^{1 2 3 4 5}

What safety data exists for the meditation app treatment?

The safety data for mindfulness-based interventions, which may include the meditation app treatment, is limited. However, a study titled 'First, do no harm: An intensive experience sampling study of adverse effects to mindfulness training' suggests that there is a need to understand the common domains, frequency, severity, risk for, and context of adverse responses to mindfulness meditation practice. This indicates that while mindfulness-based interventions are generally considered safe, there is ongoing research to better understand potential adverse effects. ^{1 6 7 8 9}

Is the treatment in the trial 'Meditation App for Emotion Regulation in Youth on Probation' a promising treatment?

Yes, the treatment is promising. Meditation and mindfulness-based interventions have shown positive effects on self-regulation, mental health, and emotional management in youth, including those in the justice system. Participants often report feeling less stressed and better able to manage emotions and behavior. ^{10 11 12 13 14}

What is the purpose of this trial?

This study is a randomized controlled trial (RCT) testing the effects of a mindfulness-based intervention delivered to justice-involved youth on probation via smartphone app on youths' emotion regulation and HIV/sexually transmitted infection (STI) risk-taking behaviors (i.e., alcohol use, cannabis use, sexual behaviors, and aggressive behaviors).

Research Team

Ashley D Kendall, PhD

Principal Investigator

University of Illinois at Chicago

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

Group I: Bodhi AIM Experimental Treatment 1 Intervention

Participants randomized to the intervention group will receive the Bodhi AIM app

Group II: HIB Active Control 1 Intervention

Participants randomized to the health promotion control group will receive the HIB 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+

Findings from Research

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]

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]

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]

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]

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]

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]

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 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]

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 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]

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]

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]

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]

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]

References

1. England 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. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Mindfulness-based relapse prevention for alcohol dependence: Findings from a randomized controlled trial. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Mindfulness training as an intervention for substance user incarcerated adolescents: a pilot grounded theory study. [2016]

4. Brazil pubmed.ncbi.nlm.nih.gov

The contribution of mindfulness to outpatient substance use disorder treatment in Brazil: a preliminary study. [2021]

5. United States 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? [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Thai Buddhism-Based Mindfulness for Pain Management in Thai Outpatients with Cancer: A Pilot Study. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Mindfulness-based stress reduction for urban youth. [2022]

8. United States 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. [2019]

9. England pubmed.ncbi.nlm.nih.gov

First, do no harm: An intensive experience sampling study of adverse effects to mindfulness training. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

A Pilot Study to Adapt a Trauma-Informed, Mindfulness-Based Yoga Intervention for Justice-Involved Youth. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Mindfulness-Based Interventions for Young Offenders: a Scoping Review. [2023]

12. England pubmed.ncbi.nlm.nih.gov

Acceptance and commitment therapy universal prevention program for adolescents: a feasibility study. [2020]

13. United States pubmed.ncbi.nlm.nih.gov

Meditation improves self-regulation over the life span. [2021]

14. United States pubmed.ncbi.nlm.nih.gov

Mindfulness-based interventions with youth: A comprehensive meta-analysis of group-design studies. [2018]