- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05353751
Kind Minds Program for Youth With Anxiety and Depression (KMP)
Examining the Effectiveness of a Mindfulness-based Intervention for Underserved Adolescents With and Without Caregiver Involvement
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Imperial, California, United States, 92251
- Imperial High School
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Kind Minds Program -Family
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
|
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.
|
|
Active Comparator: Kind Minds Program -Teen Only
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient Health Questionnaire-9
Time Frame: 12-14 weeks after baseline assessment
|
self report of depressive symptoms
|
12-14 weeks after baseline assessment
|
|
Generalized Anxiety Disorder-7
Time Frame: 12-14 weeks after baseline assessment
|
self report of anxiety symptoms
|
12-14 weeks after baseline assessment
|
|
SCARED -Screen for child anxiety and related emotional disorders
Time Frame: 12-14 weeks after baseline assessment
|
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
Time Frame: 12-14 weeks after baseline assessment
|
remission on primary anxiety or primary depressive disorder diagnosis
|
12-14 weeks after baseline assessment
|
Collaborators and Investigators
Investigators
- Principal Investigator: Denise A Chavira, PhD, University of California, Los Angeles
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 21-001218
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Depression
-
Massachusetts General HospitalRecruitingDepression | Depression - Major Depressive Disorder | Depression Chronic | Depression in Adults | Depression Disorders | Depression DisorderUnited States
-
University of California, San FranciscoNational Center for Complementary and Integrative Health (NCCIH)Active, not recruitingDepression Moderate | Depression Mild | Depression, TeenUnited States
-
ProgenaBiomeWithdrawnDepression | Depression, Postpartum | Depression, Anxiety | Depression Moderate | Depression Severe | Clinical Depression | Depression in Remission | Depression, Endogenous | Depression ChronicUnited States
-
Sorlandet Hospital HFUniversity of Oslo; Karolinska Institutet; Australian Catholic University; Helse...RecruitingAnxiety | Anxiety Depression | Depression Anxiety Disorder | Depression - Major Depressive DisorderNorway
-
Lipocine Inc.CompletedDepression, Postpartum | Postnatal Depression | Peripartum Depression | Depression, Post-Partum | Postpartum Depression (PPD) | Post-Natal DepressionUnited States
-
Washington University School of MedicineCompletedTreatment Resistant Depression | Late Life Depression | Geriatric Depression | Refractory Depression | Therapy-Resistant DepressionUnited States, Canada
-
Kintsugi Mindful Wellness, Inc.Sonar Strategies; Vituity PsychiatryActive, not recruitingDepression | Depression Moderate | Depression Severe | Depression MildUnited States
-
Kintsugi Mindful Wellness, Inc.Sonar Strategies; Kolby Walker, DO; Brittany KimbleRecruitingDepression | Depression Moderate | Depression Severe | Depression MildUnited States
-
University of CincinnatiNational Center for Complementary and Integrative Health (NCCIH)RecruitingMild DepressionUnited States
-
University of MinnesotaCompletedDepression SymptomsUnited States
Clinical Trials on Kind Minds Program
-
University of Alabama, TuscaloosaNational Institute of Mental Health (NIMH)RecruitingDepressive Symptoms | Anxiety SymptomsUnited States
-
University of Wisconsin, MadisonCompletedPsychological Distress | Loneliness | Depression, AnxietyUnited States
-
State University of New York - Upstate Medical...National Institute of Mental Health (NIMH)CompletedVelocardiofacial SyndromeUnited States
-
University of Wisconsin, MadisonRecruitingSuicidalUnited States
-
University of Wisconsin, MadisonNational Center for Complementary and Integrative Health (NCCIH); Hope for...Completed
-
University of Wisconsin, MadisonCompleted
-
University of Wisconsin, MadisonChan Zuckerberg InitiativeCompleted
-
University of Wisconsin, MadisonCompleted
-
University of Wisconsin, MadisonNational Center for Complementary and Integrative Health (NCCIH); Hope for...Completed
-
University of Wisconsin, MadisonChan Zuckerberg Initiative; Healthy Minds Innovations; Center for Healthy MindsCompletedDepression | Anxiety | Psychological Distress | Well-being | Psychological StressUnited States