Clinical trial NCT05818397: Self-Compassion for Children and Caregivers
Official title: Nurturing Compassionate Responding Towards Oneself and Others Through the Caregiver-child Relationship
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Depression
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: Mind & Life Institute
First posted: 2023-04-18
Enrollment: 25
Sex: ALL
Minimum age (years): 8
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in number of dyads in attendance each week
timeFrame: Week 1 to week 6
measure: Reasons for study attrition
timeFrame: Up to week 6
measure: Fidelity to SCCC Curriculum
timeFrame: Through study completion, up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Ryan Herringa, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: