Self-Compassion for Children and Caregivers

Study Overview
=================
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.

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

Conditions
-----------------
Depression, Anxiety

Intervention / Treatment
-----------------
* Behavioral: Self-Compassion for Children and Caregivers (SCCC)


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 11 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Self-Compassion Intervention<br> | Behavioral: Self-Compassion for Children and Caregivers (SCCC)<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |