search
Back to results

Kind Minds Program for Youth With Anxiety and Depression (KMP)

Primary Purpose

Child Anxiety, Depression

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Kind Minds Program
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Child Anxiety focused on measuring mindfulness, children, adolescents, anxiety, depression

Eligibility Criteria

12 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Participants will include:

    1. one adolescent (aged 12-17 years) with a current diagnosis of an anxiety or depressive disorder)
    2. one of their parents/caregivers.
    3. Both adolescent and caregiver must speak English to the degree necessary to participate in the intervention program, which is only available in English.
    4. 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:

    1. current alcohol or substance use disorder or suicidality
    2. lifetime diagnosis of bipolar disorder, schizophrenia, autism, conduct disorder, or developmental delay diagnosed by an independent evaluator;
    3. English reading level below 4th grade
    4. non English speaking
    5. currently receiving mindfulness-based mental health services or taking medication to treat anxiety or depression.

Sites / Locations

  • Imperial High SchoolRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Kind Minds Program -Family

Kind Minds Program -Teen Only

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Patient Health Questionnaire-9
self report of depressive symptoms
Generalized Anxiety Disorder-7
self report of anxiety symptoms
SCARED -Screen for child anxiety and related emotional disorders
self report of anxiety symptoms

Secondary Outcome Measures

Kiddie Schedule for Affective Disorders and Schizophrenia interview -anxiety and depressive disorder modules
remission on primary anxiety or primary depressive disorder diagnosis

Full Information

First Posted
February 2, 2022
Last Updated
October 31, 2022
Sponsor
University of California, Los Angeles
search

1. Study Identification

Unique Protocol Identification Number
NCT05353751
Brief Title
Kind Minds Program for Youth With Anxiety and Depression
Acronym
KMP
Official Title
Examining the Effectiveness of a Mindfulness-based Intervention for Underserved Adolescents With and Without Caregiver Involvement
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 31, 2022 (Actual)
Primary Completion Date
June 15, 2023 (Anticipated)
Study Completion Date
December 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Child Anxiety, Depression
Keywords
mindfulness, children, adolescents, anxiety, depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Kind Minds Program -Family
Arm Type
Experimental
Arm Description
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
Arm Title
Kind Minds Program -Teen Only
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Kind Minds Program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Patient Health Questionnaire-9
Description
self report of depressive symptoms
Time Frame
12-14 weeks after baseline assessment
Title
Generalized Anxiety Disorder-7
Description
self report of anxiety symptoms
Time Frame
12-14 weeks after baseline assessment
Title
SCARED -Screen for child anxiety and related emotional disorders
Description
self report of anxiety symptoms
Time Frame
12-14 weeks after baseline assessment
Secondary Outcome Measure Information:
Title
Kiddie Schedule for Affective Disorders and Schizophrenia interview -anxiety and depressive disorder modules
Description
remission on primary anxiety or primary depressive disorder diagnosis
Time Frame
12-14 weeks after baseline assessment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Denise A Chavira, PhD
Phone
3108258466
Email
dchavira@psych.ucla.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Danielle Smith, PhD
Email
Danielle.Sayre@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Denise A Chavira, PhD
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
Imperial High School
City
Imperial
State/Province
California
ZIP/Postal Code
92251
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joe Apodaca
Phone
760-540-1366
Email
japodaca@imperialusd.org

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Kind Minds Program for Youth With Anxiety and Depression

We'll reach out to this number within 24 hrs