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Self-Compassion for Children and Caregivers (SCCC)

Primary Purpose

Anxiety, Depression

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Self-Compassion for Children and Caregivers (SCCC)
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety

Eligibility Criteria

8 Years - 11 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Youth between the ages of 8 and 11 years old Youth are currently attending school at Glenn Stephens Elementary School in Madison, WI. 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

Sites / Locations

  • University of WisconsinRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Self-Compassion Intervention

Arm Description

Outcomes

Primary Outcome Measures

Change in number of dyads in attendance each week
Feasibility and acceptability will be measured using attendance records each week of the program
Reasons for study attrition
Feasibility and acceptability will be assessed through reasons provided by dyads for leaving the program
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.

Secondary Outcome Measures

Full Information

First Posted
April 3, 2023
Last Updated
October 5, 2023
Sponsor
University of Wisconsin, Madison
Collaborators
Mind & Life Institute
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1. Study Identification

Unique Protocol Identification Number
NCT05818397
Brief Title
Self-Compassion for Children and Caregivers
Acronym
SCCC
Official Title
Nurturing Compassionate Responding Towards Oneself and Others Through the Caregiver-child Relationship
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
May 2025 (Anticipated)
Study Completion Date
May 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
Collaborators
Mind & Life Institute

4. Oversight

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

5. Study Description

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
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Self-Compassion Intervention
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Self-Compassion for Children and Caregivers (SCCC)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in number of dyads in attendance each week
Description
Feasibility and acceptability will be measured using attendance records each week of the program
Time Frame
Week 1 to week 6
Title
Reasons for study attrition
Description
Feasibility and acceptability will be assessed through reasons provided by dyads for leaving the program
Time Frame
Up to week 6
Title
Fidelity to SCCC Curriculum
Description
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.
Time Frame
Through study completion, up to 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Youth between the ages of 8 and 11 years old Youth are currently attending school at Glenn Stephens Elementary School in Madison, WI. 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sara Heyn, JD, PhD
Phone
303-396-2116
Email
sheyn@wisc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ryan Herringa, MD, PhD
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sara Heyn, JD, PhD
Phone
303-396-2116
Email
sheyn@wisc.edu
First Name & Middle Initial & Last Name & Degree
Ryan Herringa, MD, PhD

12. IPD Sharing Statement

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Self-Compassion for Children and Caregivers

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