NCT05818397

Brief Summary

The Self-Compassion for Children and Caregivers Study aims to understand if an online course designed to help kids and their caregivers learn self-compassion is feasible, enjoyable, and helpful for well-being and relationships in families from diverse backgrounds. Children ages 8-11 who have a caregiver willing to participate with them will:

  • Attend 2 in-person study visits (about 1-1.5 hour each) that includes
  • A survey for caregiver and child
  • A brief computer puzzle challengetask while heart rate and sweat is recorded (child)
  • A brief discussion about how the challenge went
  • Participate in a 6-session, online self-compassion course with other families (see back)
  • Provide feedback about how the course went

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for not_applicable anxiety

Timeline
Completed

Started Oct 2023

Typical duration for not_applicable anxiety

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 3, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 18, 2023

Completed
6 months until next milestone

Study Start

First participant enrolled

October 16, 2023

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 16, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 16, 2025

Completed
Last Updated

June 3, 2025

Status Verified

June 1, 2025

Enrollment Period

1.6 years

First QC Date

April 3, 2023

Last Update Submit

June 2, 2025

Conditions

AnxietyDepression

Outcome Measures

Primary Outcomes (3)

  • Change in number of dyads in attendance each week

    Feasibility and acceptability will be measured using attendance records each week of the program

    Week 1 to week 6

  • Reasons for study attrition

    Feasibility and acceptability will be assessed through reasons provided by dyads for leaving the program

    Up to week 6

  • Fidelity to SCCC Curriculum

    The SCCC Fidelity Checklist is a subjective checklist for evidence shown for an array of items covered during each session. No evidence, some evidence, and definite evidence are selected, with higher counts of definite evidence reflecting greater fidelity to the curriculum.

    Through study completion, up to 2 years

Study Arms (2)

Self-Compassion Intervention - English speaking

EXPERIMENTAL
Behavioral: Self-Compassion for Children and Caregivers (SCCC)

Self-Compassion Intervention - Spanish speaking

EXPERIMENTAL
Behavioral: Self-Compassion for Children and Caregivers (SCCC)

Interventions

Self-Compassion for Children and Caregivers (SCCC)BEHAVIORAL

A standardized, manualized adaptation of the mindful self-compassion curriculum for adults, designed for online delivery. Dyads join a group video conference call along with other caregiver-child dyads and and up to two experienced SCCC facilitators. Sessions occur 1-hour per week for 6 weeks at a time convenient for the group.

Self-Compassion Intervention - English speakingSelf-Compassion Intervention - Spanish speaking

Eligibility Criteria

Age8 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Youth between the ages of 8 and 11 years old
  • Youth are currently attending an elementary school in the Madison Metropolitan School District (MMSD).
  • Accompanied by a willing and able caregiver (e.g., parent, grandparent, legal guardian)
  • Access to an internet-enabled device
  • Both parent and youth participants must be able to read/write in English
  • Meet threshold (T greater than 59) for clinically significant anxiety and/or depression from either parent- or youth-report of symptoms
  • Youth between the ages of 8 and 11 years old
  • Accompanied by an eligible caregiver participant
  • Safe access to a computer or mobile device that can connect to the internet
  • Visual acuity adequate to read text on a computer or mobile device
  • Able to provide assent and complete surveys in Spanish

You may not qualify if:

  • Are unable to provide adequate informed consent and/or assent
  • Parent or youth that is currently impaired by any medical condition that would prevent study participation
  • Active self-reported psychotic disorder
  • Previous completion of a Mindfulness and Self-Compassion for children and Caregivers (MSC-CC) program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53705, United States

Location

MeSH Terms

Conditions

Anxiety DisordersDepression

Interventions

Caregivers

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Health PersonnelHealth Care Facilities Workforce and Services

Study Officials

  • Ryan Herringa, MD, PhD

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 3, 2023

First Posted

April 18, 2023

Study Start

October 16, 2023

Primary Completion

May 16, 2025

Study Completion

May 16, 2025

Last Updated

June 3, 2025

Record last verified: 2025-06

Locations

US(1)