Kind Minds Program for Youth With Anxiety and Depression

Study Overview
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Brief Summary
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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.

Official Title
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Examining the Effectiveness of a Mindfulness-based Intervention for Underserved Adolescents With and Without Caregiver Involvement

Conditions
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Child Anxiety, Depression

Intervention / Treatment
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* Behavioral: Kind Minds Program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants will include: one adolescent (aged 12-17 years) with a current diagnosis of an anxiety or depressive disorder) one of their parents/caregivers. Both adolescent and caregiver must speak English to the degree necessary to participate in the intervention program, which is only available in English. Parent and youth must have a smart phone and be willing to download the online mindfulness program. Exclusion Criteria: Exclusion criteria apply to both caregiver and adolescent and include: current alcohol or substance use disorder or suicidality lifetime diagnosis of bipolar disorder, schizophrenia, autism, conduct disorder, or developmental delay diagnosed by an independent evaluator; English reading level below 4th grade non English speaking currently receiving mindfulness-based mental health services or taking medication to treat anxiety or depression.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Kind Minds Program -Family<br>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 | Behavioral: Kind Minds Program<br>* The KMP intervention uses an online mindfulness phone based program. During the 9-week program, Community Health Worker (CHW) Kindness Coaches will meet weekly for 30 minutes via Zoom with either a) the caregiver and adolescent (in separate meetings), or b) the adolescent only to review and complete a new session using the online mindfulness program. Participants will be prompted to complete mindfulness activities between sessions by notifications, conducive to their school and work schedules. Weekly content and meditations/activities focus on mindfulness skills of present moment awareness, nonjudgment, compassion, and gratitude.<br>|
| Active Comparator: Kind Minds Program -Teen Only<br>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. | Behavioral: Kind Minds Program<br>* The KMP intervention uses an online mindfulness phone based program. During the 9-week program, Community Health Worker (CHW) Kindness Coaches will meet weekly for 30 minutes via Zoom with either a) the caregiver and adolescent (in separate meetings), or b) the adolescent only to review and complete a new session using the online mindfulness program. Participants will be prompted to complete mindfulness activities between sessions by notifications, conducive to their school and work schedules. Weekly content and meditations/activities focus on mindfulness skills of present moment awareness, nonjudgment, compassion, and gratitude.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Health Questionnaire-9 | self report of depressive symptoms | 12-14 weeks after baseline assessment | 
| Generalized Anxiety Disorder-7 | self report of anxiety symptoms | 12-14 weeks after baseline assessment | 
| SCARED -Screen for child anxiety and related emotional disorders | self report of anxiety symptoms | 12-14 weeks after baseline assessment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Kiddie Schedule for Affective Disorders and Schizophrenia interview -anxiety and depressive disorder modules | remission on primary anxiety or primary depressive disorder diagnosis | 12-14 weeks after baseline assessment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mindfulness, children, adolescents, anxiety, depression