Kind Minds Program for Youth Anxiety and Depression

(KMP Trial)

Overseen By Danielle Smith, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Los Angeles

Must not be taking: Anxiety, Depression medications

Disqualifiers: Substance use, Suicidality, Bipolar, others

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

Compensation: Varies

Number of Visits: 3

30 Participants Needed

Trial Summary

What is the purpose of this trial?

Rates of anxiety and depression in youth are substantial, causing a major unmet need for effective interventions. Participation in mindfulness interventions has been demonstrated to reduce anxiety and depressive symptoms among teenagers. Parents' participation in mindfulness interventions has also been shown to reduce their children's mental health symptoms. However, there is no available evidence regarding potential additional benefits for adolescents' mental health of having both the adolescent and their parent or caregiver learn and practice mindfulness simultaneously. This pilot intervention study aims to explore potential additive effects of parent/caregiver participation in a digitally-based, kindness-focused, coached mindfulness intervention program for adolescents that lasts 9 weeks. Participating parent/caregiver-child pairs (n = 30) will include one teenager between 12 and 17 years old with a current diagnosis of an anxiety or depressive disorder and one parent/caregiver. All adolescent participants will take part in the mindfulness intervention. Half of the parents/caregivers will be randomized to also take part in the mindfulness program. Outcomes will be compared between families in which only the teen participates in the mindfulness program and families in which the teen and parent/caregiver participate in the intervention. Adolescents and parents/caregivers will take part in evaluations before, in the middle of, and after the end of the mindfulness program, meaning that participation in the study will take a total of approximately 12 weeks. Pre, mid, and post evaluations will include online questionnaires. Pre and post evaluations will also include clinical interviews via phone or video conference. Evaluations will include measures of mental health diagnoses and symptoms, mood, interpersonal and family functioning, mindfulness, and perceptions of/satisfaction with the program. Participating adolescents and parents/caregivers will also fill out weekly brief questionnaires of anxiety and depressive symptoms. The primary outcome of interest is adolescent mental health, including anxiety and depressive symptoms.

Will I have to stop taking my current medications?

Yes, participants must not be taking medication to treat anxiety or depression to join this trial.

What data supports the effectiveness of the Kind Minds Program treatment for youth anxiety and depression?

The Cool Kids program, which is similar to the Kind Minds Program, has shown that 60-80% of children with anxiety improve after completing it. Additionally, cognitive behavioral therapy (CBT), a component of Cool Kids, has been effective in reducing anxiety symptoms and improving daily functioning in children. ^{1 2 3 4 5}

Is the Kind Minds Program for Youth Anxiety and Depression safe for humans?

There is limited information on the safety of psychological interventions like the Kind Minds Program, but studies emphasize the importance of monitoring adverse events (unintended negative effects) to ensure they are not harmful. More comprehensive data collection and reporting are needed to fully understand the safety of such treatments. ^{5 6 7 8 9}

How is the Kind Minds Program treatment different from other treatments for youth anxiety and depression?

The Kind Minds Program is unique because it likely focuses on a transdiagnostic approach, which means it targets multiple related conditions like anxiety and depression simultaneously, potentially improving access to treatment for youths. This approach is different from traditional treatments that may focus on a single condition at a time. ^{2 4 10 11 12}

Research Team

Denise A Chavira, PhD

Principal Investigator

University of California, Los Angeles

Eligibility Criteria

This trial is for teens aged 12-17 with anxiety or depression and their parents/caregivers. Both must speak English well enough to use an English-only digital mindfulness program, have a smartphone, and agree to download the program. They can't join if they're already receiving mindfulness therapy, taking certain medications, or have specific mental health conditions like bipolar disorder or autism.

Inclusion Criteria

My child and I both have smartphones and are willing to download a mindfulness app.

I am aged 12-17 and diagnosed with anxiety or depression.

I'm sorry, but this is not a complete criterion. Can you please provide me with the full criterion so I can accurately summarize it for you?

Exclusion Criteria

English reading level below 4th grade

non English speaking

I am currently getting mindfulness therapy or taking medication for anxiety or depression.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-3 weeks

Mindfulness Intervention

Adolescents participate in a 9-week digitally-based, kindness-focused, coached mindfulness intervention program. Half of the parents/caregivers are also randomized to participate.

9 weeks

Weekly video conference support

Evaluation

Pre, mid, and post evaluations including online questionnaires and clinical interviews via phone or video conference.

12 weeks

3 evaluations (pre, mid, post)

Follow-up

Participants are monitored for mental health outcomes, including anxiety and depressive symptoms, 12-14 weeks after baseline assessment.

2 weeks

Treatment Details

Interventions

• Kind Minds Program

Trial Overview The Kind Minds Program is being tested to see if it helps reduce symptoms of anxiety and depression in youth when both the teen and parent practice mindfulness together. The study compares outcomes between families where only the teen participates versus those where both teen and parent engage in the 9-week online program.

Participant Groups

Group I: Kind Minds Program -Family Experimental Treatment 1 Intervention

In the Family condition (KMP-Fam), both caregiver and adolescent will receive the KMP intervention via an online mindfulness program, augmented by weekly video conference support from a Community Health Worker (CHW) Kindness Coach

Group II: Kind Minds Program -Teen Only Active Control 1 Intervention

In the Teen-Only condition (KMP-TO), only the adolescent will receive the KMP intervention via an online mindfulness program augmented by weekly video conference support from a CHW Kindness Coach.

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials

1,594

Recruited

10,430,000+

Findings from Research

The Cool Kids programme significantly reduced anxiety-related interference in the lives of both children and their parents, as measured by the Child Anxiety Life Interference Scale, in a naturalistic study involving 79 participants (39 parents and 40 children).

While the intervention showed effectiveness in a real-world clinical setting, the level of improvement observed during the follow-up period was not as pronounced as in previous efficacy studies, indicating that while the programme is implementable in practice, outcomes may vary from controlled research settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is the Cool Kids programme working in outpatient psychiatric clinics? A Danish naturalistic effectiveness study. Djurhuus, ID., Bikic, A.[2019]

A systematic review identified eight studies of internet-based programs for treating anxiety and depression in children and adolescents, with most interventions based on cognitive behavior therapy.

Six out of eight studies reported reductions in symptoms of anxiety and/or depression after the interventions, indicating early support for the effectiveness of these online programs, although more rigorous research is needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review of internet-based prevention and treatment programs for anxiety and depression in children and adolescents. Calear, AL., Christensen, H.[2022]

Mindfulness-based cognitive therapy offers a promising skills-based approach for young people with depression or anxiety who do not fully respond to standard treatments.

This therapy equips participants with sustainable tools to manage stress and negative moods, potentially improving their overall mental health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Could mindfulness-based cognitive therapy prevent a lifelong recurrent course of depression or anxiety by addressing key mechanisms of vulnerability in high-risk adolescents? Ford, T., Richardson, J., Wilkinson, K., et al.[2021]

The transdiagnostic EMOTION program, a preventive cognitive behavioral therapy for children aged 8-12, demonstrated significant long-term reductions in self-reported anxious symptoms and parental reports of both anxious and depressive symptoms after 12 months, based on a study involving 795 children.

While the intervention effectively reduced anxiety symptoms, the results for depressive symptoms were less conclusive, as only parental reports indicated a reduction, suggesting further investigation is needed for the efficacy on self-reported depressive symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A 12-month follow-up of a transdiagnostic indicated prevention of internalizing symptoms in school-aged children: the results from the EMOTION study. Loevaas, MES., Lydersen, S., Sund, AM., et al.[2023]

The Cool Kids (CK) program, a 10-session cognitive behavioral therapy (CBT) group intervention, effectively reduced anxiety symptoms in 57 Spanish children and adolescents aged 7-17 with anxiety disorders, as evidenced by global registered measures.

Participants who attended more sessions of the CK program experienced greater improvements, indicating that increased engagement in the therapy correlates with better outcomes in reducing anxiety severity and enhancing daily functioning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cool Kids: Cognitive Behavioral Therapy in a Spanish Sample of Children and Adolescents with Anxiety Disorders. Galí, D., Forcadell, E., Primé-Tous, M., et al.[2023]

This study will analyze adverse events in psychotherapy for youth with OCD by including at least 128 participants aged 8-17, comparing family-based cognitive behavioral therapy (FCBT) and family-based psychoeducation and relaxation training (FPRT).

The mixed methods approach will combine quantitative assessments of adverse events with qualitative interviews to better understand their nature and causes, aiming to improve the safety and effectiveness of psychotherapy for OCD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events in cognitive behavioral therapy and relaxation training for children and adolescents with obsessive-compulsive disorder: A mixed methods study and analysis plan for the TECTO trial. Pretzmann, L., Christensen, SH., Bryde Christensen, A., et al.[2023]

In a study involving 488 participants aged 7 to 17, no significant differences in adverse events (AEs) were found between sertraline (an SSRI) and placebo, indicating that sertraline is generally safe for treating anxiety disorders in children and adolescents.

However, children (aged 12 and under) reported higher rates of psychiatric AEs across all treatment conditions, suggesting that closer monitoring for these side effects is necessary in younger patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Child/Adolescent anxiety multimodal study: evaluating safety. Rynn, MA., Walkup, JT., Compton, SN., et al.[2022]

The safety of psychological interventions is critical, as adverse events (AEs) can occur and must be carefully evaluated to ensure that these interventions do not cause harm before being deemed beneficial.

There is a pressing need for standardized protocols for assessing and reporting AEs in psychological interventions to improve transparency, consistency, and ultimately enhance clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Editorial: Primum non nocere - are adverse events accurately reported in studies on psychological interventions for children? Purgato, M., Cortese, S.[2023]

The comprehensive body system review (BSR) in the Safety Monitoring Uniform Report Form (SMURF) identified 129 additional adverse events (AEs) in pediatric patients, significantly more than the 48 AEs from the general inquiry and 16 from the drug-specific inquiry, highlighting its effectiveness in capturing important safety data.

Parents found the detailed BSR acceptable and satisfactory, while clinicians did not share the same level of acceptance, indicating a potential gap in the perceived utility of detailed adverse event reporting methods in pediatric psychopharmacology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of increasingly detailed elicitation methods for the assessment of adverse events in pediatric psychopharmacology. Greenhill, LL., Vitiello, B., Fisher, P., et al.[2007]

The pediatric transdiagnostic brief behavioral therapy (BBT) program significantly increased anxiety-free days and quality-adjusted life-years (QALYs) compared to assisted referral to community outpatient mental health care (ARC) in a study of 185 youths, indicating its effectiveness in treating anxiety and depression.

BBT was found to be highly cost-effective, with a 95.6% probability of being cost-effective compared to ARC at a willingness-to-pay threshold of $50,000 per QALY, suggesting it is a financially viable option for improving youth mental health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cost-effectiveness of Brief Behavioral Therapy for Pediatric Anxiety and Depression in Primary Care. Lynch, FL., Dickerson, JF., Rozenman, MS., et al.[2021]

The EMPATHY program, a school-based initiative aimed at reducing suicidal thoughts and mental health issues among students aged 11-18, showed a significant decrease in suicidality rates from 4.4% at baseline to 2.8% after 15 months, indicating its effectiveness in improving student mental health.

In addition to reducing suicidality, the program also led to significant reductions in depression and anxiety scores over the 15-month period, demonstrating that multimodal interventions can positively impact the mental well-being of a large student population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term Results from the Empowering a Multimodal Pathway Toward Healthy Youth Program, a Multimodal School-Based Approach, Show Marked Reductions in Suicidality, Depression, and Anxiety in 6,227 Students in Grades 6-12 (Aged 11-18). Silverstone, PH., Bercov, M., Suen, VYM., et al.[2023]

Effective early treatment of youth anxiety, including cognitive behavior therapy (CBT) and medication, significantly reduces the risk of developing chronic depressive symptoms and suicidal behavior in the long term, as shown in a study of 319 participants followed for an average of 6.25 years.

The study found that remission from anxiety treatment predicted a lower likelihood of suicidal behavior, highlighting the importance of addressing anxiety early to prevent future mood disorders and suicidality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mood and suicidality outcomes 3-11 years following pediatric anxiety disorder treatment. Keeton, CP., Caporino, NE., Kendall, PC., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Is the Cool Kids programme working in outpatient psychiatric clinics? A Danish naturalistic effectiveness study. [2019]

2. Australia pubmed.ncbi.nlm.nih.gov

Review of internet-based prevention and treatment programs for anxiety and depression in children and adolescents. [2022]

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

Could mindfulness-based cognitive therapy prevent a lifelong recurrent course of depression or anxiety by addressing key mechanisms of vulnerability in high-risk adolescents? [2021]

4. England pubmed.ncbi.nlm.nih.gov

A 12-month follow-up of a transdiagnostic indicated prevention of internalizing symptoms in school-aged children: the results from the EMOTION study. [2023]

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

Cool Kids: Cognitive Behavioral Therapy in a Spanish Sample of Children and Adolescents with Anxiety Disorders. [2023]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Adverse events in cognitive behavioral therapy and relaxation training for children and adolescents with obsessive-compulsive disorder: A mixed methods study and analysis plan for the TECTO trial. [2023]

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

Child/Adolescent anxiety multimodal study: evaluating safety. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Editorial: Primum non nocere - are adverse events accurately reported in studies on psychological interventions for children? [2023]

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

Comparison of increasingly detailed elicitation methods for the assessment of adverse events in pediatric psychopharmacology. [2007]

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

Cost-effectiveness of Brief Behavioral Therapy for Pediatric Anxiety and Depression in Primary Care. [2021]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Long-term Results from the Empowering a Multimodal Pathway Toward Healthy Youth Program, a Multimodal School-Based Approach, Show Marked Reductions in Suicidality, Depression, and Anxiety in 6,227 Students in Grades 6-12 (Aged 11-18). [2023]

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

Mood and suicidality outcomes 3-11 years following pediatric anxiety disorder treatment. [2022]