- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05818397
Self-Compassion for Children and Caregivers (SCCC)
Nurturing Compassionate Responding Towards Oneself and Others Through the Caregiver-child Relationship
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Wisconsin
-
Madison, Wisconsin, United States, 53705
- University of Wisconsin
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria - English speaking:
- 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
Inclusion Criteria - Spanish speaking:
- 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
Exclusion Criteria - English speaking:
- 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
Exclusion Criteria - Spanish speaking:
- Previous completion of a Mindfulness and Self-Compassion for children and Caregivers (MSC-CC) program
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Self-Compassion Intervention - English speaking
|
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.
|
|
Experimental: Self-Compassion Intervention - Spanish speaking
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in number of dyads in attendance each week
Time Frame: Week 1 to week 6
|
Feasibility and acceptability will be measured using attendance records each week of the program
|
Week 1 to week 6
|
|
Reasons for study attrition
Time Frame: Up to week 6
|
Feasibility and acceptability will be assessed through reasons provided by dyads for leaving the program
|
Up to week 6
|
|
Fidelity to SCCC Curriculum
Time Frame: 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.
|
Through study completion, up to 2 years
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Ryan Herringa, MD, PhD, University of Wisconsin, Madison
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023-0325
- SMPH/PSYCHIATRY/PSYCHIATRY (Other Identifier: UW Madison)
- PEACEFP2022-9936264010 (Other Grant/Funding Number: Mind & Life Institute)
- Protocol Version 11/27/2024 (Other Identifier: UW Madison)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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