SCCC: Self-Compassion for Children and Caregivers

• Sponsor: University of Wisconsin, Madison (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05818397
• Collaborator: Mind & Life Institute (Other)
• Enrollment: 24
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 24
• Patients Per Site Per Month: 1

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Anxiety; Depression	Behavioral: Self-Compassion for Children and Caregivers (SCCC)	N/A

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 with elevated anxiety and/or depressive symptoms 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 potential physiological, relational/behavioral, and psychological changes associated with SCCC participation.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 24 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Nurturing Compassionate Responding Towards Oneself and Others Through the Caregiver-child Relationship
• Anticipated Study Start Date: May 1, 2023
• Anticipated Primary Completion Date: May 1, 2025
• Anticipated Study Completion Date: May 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Self-Compassion 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.

Outcome Measures

Primary Outcome Measures

1. Change in number of dyads in attendance each week [Week 1 to week 6]

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

2. Reasons for study attrition [Up to week 6]

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

3. Fidelity to SCCC Curriculum [Through study completion, up to 2 years]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 8 Years to 11 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

• Youth is reporting current, clinically significant anxiety and/or depression symptoms, as defined by a T-score of 60 or greater (1 S.D. above population average levels of symptomatology) on the PROMIS Anxiety and/or PROMIS Depression

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Wisconsin	Madison	Wisconsin	United States	53705

Sponsors and Collaborators

• University of Wisconsin, Madison
• Mind & Life Institute

Investigators

• Principal Investigator: Ryan Herringa, MD, PhD, University of Wisconsin, Madison

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Wisconsin, Madison
• ClinicalTrials.gov Identifier: NCT05818397
• Other Study ID Numbers: 2023-0325; PEACEFP2022-9936264010; SMPH/PSYCHIATRY/PSYCHIATRY; Protocol Version
• First Posted: Apr 18, 2023
• Last Update Posted: Apr 18, 2023
• Last Verified: Apr 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Depression

Study Results

No Results Posted as of Apr 18, 2023