AnxietySCCCNCT05818397
Self-Compassion for Children and Caregivers
A study testing Self-Compassion for Children and Caregivers (SCCC) in people with Anxiety and Depression, run by University of Wisconsin, Madison at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 11 years
- Conditions the study is for
- Anxiety, Depression
- What is being tested?
- Self-Compassion for Children and Caregivers (SCCC)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Oct 2023to 16 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
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- 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
Who cannot join
- 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
- Previous completion of a Mindfulness and Self-Compassion for children and Caregivers (MSC-CC) program
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Anxiety, Depression
- Being tested
- Self-Compassion for Children and Caregivers (SCCC)
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-Compassion for Children and Caregivers (SCCC)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Self-Compassion Intervention - English speaking | Experimental | Not described Receives: Behavioral: Self-Compassion for Children and Caregivers (SCCC) |
| Self-Compassion Intervention - Spanish speaking | Experimental | Not described Receives: Behavioral: Self-Compassion for Children and Caregivers (SCCC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in number of dyads in attendance each week
Feasibility and acceptability will be measured using attendance records each week of the program
Measured: Week 1 to week 6
Reasons for study attrition
Feasibility and acceptability will be assessed through reasons provided by dyads for leaving the program
Measured: 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.
Measured: Through study completion, up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start16 Oct 2023
- Primary completion16 May 2025
- Study completion16 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- Mind & Life Institute
- Responsible party
- Sponsor
- Investigators
- Ryan Herringa, MD, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05818397
- Sponsor's protocol ID
- 2023-0325
- Other IDs
- PEACEFP2022-9936264010, SMPH/PSYCHIATRY/PSYCHIATRY, Protocol Version 11/27/2024
- Acronym
- SCCC
- Status last verified
- Jun 2025
- First submitted
- 3 Apr 2023
- Last updated
- 3 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nurturing Compassionate Responding Towards Oneself and Others Through the Caregiver-child Relationship
- ClinicalTrials.gov ID
- NCT05818397
- Acronym / sponsor ID
- SCCC / 2023-0325
- Conditions
- Anxiety, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- Mind & Life Institute
- Study start
- 16 Oct 2023 (actual)
- Primary completion
- 16 May 2025 (actual)
- Study completion
- 16 May 2025 (actual)
- First posted
- 18 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self-Compassion Intervention - English speaking | Experimental | Behavioral: Self-Compassion for Children and Caregivers (SCCC) |
| Self-Compassion Intervention - Spanish speaking | Experimental | Behavioral: Self-Compassion for Children and Caregivers (SCCC) |
Who may qualify
- Ages
- 8 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (5 listed)
- 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
- Previous completion of a Mindfulness and Self-Compassion for children and Caregivers (MSC-CC) program
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 and up to two experienced SCCC facilitators. Sessions occur 1-hour per week for 6 weeks at a time convenient for the group. | Behavioural | Self-Compassion Intervention - English speaking, Self-Compassion Intervention - Spanish speaking |
Primary outcome
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
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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ryan Herringa, MD, PhD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-Compassion for Children and Caregivers (SCCC) in people with Anxiety and Depression, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in number of dyads in attendance each week (time frame: Week 1 to week 6). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2025.