Self-Compassion for Children and Caregivers

Depression Clinical Trial

— SCCC  

Official title:

Nurturing Compassionate Responding Towards Oneself and Others Through the Caregiver-child Relationship

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05818397
• Other study ID #: 2023-0325
• Secondary ID: PEACEFP2022-9936
• Status: Recruiting
• Phase: N/A
• Start date: October 16, 2023
• Est. completion date: May 2025

Study information

• Verified date: October 2023
• Source: University of Wisconsin, Madison
• Contact: Sara Heyn, JD, PhD
• Phone: 303-396-2116
• Email: sheyn[@]wisc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

This pilot study examines the feasibility, acceptability, and preliminary outcomes of the Self-Compassion for Children and Caregivers (SCCC) program. Twenty-four children ages 8-11 and a primary caregiver will be recruited from a racially diverse school community to participate in 6 1-hour group intervention sessions over 6 weeks. Feasibility and acceptability data will guide program refinements; pre and post assessments will explore dimensional changes in anxiety/depression symptoms as well as potential physiological, relational/behavioral changes associated with SCCC participation.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: May 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 11 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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
• Current use of psychotropic medication is not exclusionary. However, certain medications that may impact physiology recordings may be excluded (e.g. those with direct impacts on the sympathetic nervous system). Exclusionary medications will be decided on a case-by-case basis, per discretion of the PI, a pediatric psychiatrist

Related Conditions & MeSH terms

• Anxiety
• Depression

Intervention

Behavioral:
• Self-Compassion for Children and Caregivers (SCCC)
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 an experienced SCCC facilitator. Sessions occur 1-hour per week for 6 weeks at a time convenient for the group.

Locations

Country	Name	City	State
United States	University of Wisconsin	Madison	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	Mind & Life Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Reasons for study attrition	Feasibility and acceptability will be assessed through reasons provided by dyads for leaving the program	Up to week 6
Primary	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