NCT05353751

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 2, 2022

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 29, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

May 31, 2022

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

March 24, 2026

Status Verified

March 1, 2026

Enrollment Period

3.6 years

First QC Date

February 2, 2022

Last Update Submit

March 23, 2026

Conditions

Keywords

mindfulnesschildrenadolescentsanxietydepression

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (1)

  • Kiddie Schedule for Affective Disorders and Schizophrenia interview -anxiety and depressive disorder modules

    12-14 weeks after baseline assessment

Study Arms (2)

Kind Minds Program -Family

EXPERIMENTAL

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

Kind Minds Program -Teen Only

ACTIVE COMPARATOR

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

Interventions

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.

Kind Minds Program -FamilyKind Minds Program -Teen Only

Eligibility Criteria

Age12 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Imperial High School

Imperial, California, 92251, United States

Location

MeSH Terms

Conditions

DepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Study Officials

  • Denise A Chavira, PhD

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 2, 2022

First Posted

April 29, 2022

Study Start

May 31, 2022

Primary Completion

December 30, 2025

Study Completion

December 30, 2025

Last Updated

March 24, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations