Protocol for Self-Compassion Intervention for Teens With Diabetes Type 1 and Their Caregivers

NCT05437913 | Unknown

• 1 other identifier: SWEET2021
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to examine the feasibility and potential effectiveness of a short (4 sessions) self-compassion intervention for adolescents with T1D and their caregivers on psychological, metabolic, and behavioral outcomes.

Conditions

Diabetes type1

Outcome Measures

Primary Outcomes (10)

• Change in Self-report psychological variables: depression (caregivers )

  \- 2 items for caregivers: PHQ-2 (Kroenke, 2003; Spanish version: Wulsin et al., 2002)

  change in PHQ from pre (Day 1) to post (Day 30). Change in PHQ from post (Day30) to Follow up3 (Month 3). Change in PHQ from Follow up 3 (month 3) to Follow up6 (Month 6)

• Change in Self-report psychological variables: depression ( teens)

  \- 2 items for teens: PHQ-2 (Richardson et al., 2010; Spanish version: Arrieta et al., 2017)

  change in PHQ from pre (Day 1) to post (Day 30). Change in PHQ from post (Day30) to Follow up3 (Month 3). Change in PHQ from Follow up 3 (month 3) to Follow up6 (Month 6)

• Change in Self-report psychological variables: self-compassion (caregivers)

  \- 20 items for caregivers: SOCS-S (Gu et al., 2020); Spanish version back forward translation

  Change in SOCS-S from pre (Day 1) to post (Day 30). Change in SOCS-S from post (Day 30) to follow up3 (Month 3). Change in SOCS-S from follow up 3 (month 3) to follow up 6 (month 6).

• Change in Self-report psychological variables: self-compassion (teens)

  \- 20 items for teens: SOCS-S (Gu et al., 2020); Spanish version back forward translation and adapted to teens

  Change in SOCS-S from pre (Day 1) to post (Day 30). Change in SOCS-S from post (Day 30) to follow up3 (Month 3). Change in SOCS-S from follow up 3 (month 3) to follow up 6 (month 6).

• change in Self-report psychological variables: self-criticism (caregivers)

  \- 14 items for caregivers: FSCRS-SR (Gilbert, Clarke, Hempel, Miles \& Irons, 2004); Spanish version back forward translation

  Change in FSCRS-SR from pre (Day 1) to post (Day 30). Change in FSCRS-SR from post (Day 30) to follow up3 (Month 3). Change in FSCRS-SR from follow up 3 (month 3) to follow up 6 (month 6).

• Change in Self-report psychological variables: self-criticism (teens)

  \- 14 items for teens: FSCRS-SR (Gilbert, Clarke, Hempel, Miles \& Irons, 2004); Spanish version back forward translation and adapted to teens

  Change in FSCRS-SR from pre (Day 1) to post (Day 30). Change in FSCRS-SR from post (Day 30) to follow up3 (Month 3). Change in FSCRS-SR from follow up 3 (month 3) to follow up 6 (month 6).

• Change in Self-report psychological variables: self care (caregivers)

  \- 24 items for caregivers: B-MSC (Cook-Cottone, 2018); Spanish version back forward translation

  Change in B-MSC from pre (Day 1) to post (Day 30). Change in B-MSC from post (Day 30) to follow up3 (Month 3). Change in B-MSC from follow up 3 (month 3) to follow up 6 (month 6).

• Change in Self-report psychological variables: self care (teens)

  \- 24 items for teens: B-MSC (Cook-Cottone, 2018); Spanish version back forward translation and adapted to teens

  Change in B-MSC from pre (Day 1) to post (Day 30). Change in B-MSC from post (Day 30) to follow up3 (Month 3). Change in B-MSC from follow up 3 (month 3) to follow up 6 (month 6).

• Change in Self-report psychological variables: interoceptive awareness (caregivers)

  \- 32 items for caregivers: MAIA-2 (Mehling et al., 2018); Spanish version back forward translation

  Change in MAIA-2 from pre (Day 1) to post (Day 30). Change in MAIA-2 from post (Day 30) to follow up3 (Month 3). Change in MAIA-2 from follow up 3 (month 3) to follow up 6 (month 6).

• Change in Self-report psychological variables: interoceptive awareness (teens)

  \- 32 items for teens: MAIA-Y (Joenes et al., 2020); Spanish version back forward translation and adapted to teens

  Change in MAIA-2 from pre (Day 1) to post (Day 30). Change in MAIA-2 from post (Day 30) to follow up3 (Month 3). Change in MAIA-2 from follow up 3 (month 3) to follow up 6 (month 6).

Secondary Outcomes (22)

• change in metabolic outcome 1 (only teens)

  Change in HbA1c from pre (Day 1) to post (Day 30). Change in HbA1c from post (Day 30) to follow up3 (Month 3). Change in HbA1c from follow up 3 (month 3) to follow up 6 (month 6).

• change in metabolic outcome 2 (only teens)

  Change in TiR from pre (Day 1) to post (Day 30). Change in TiR from post (Day 30) to follow up3 (Month 3). Change in TiR from follow up 3 (month 3) to follow up 6 (month 6).

• Change in Self-report diabetes-related variables: diabetes-specific emotional distress (caregivers)

  Change in PAID-P from pre (Day 1) to post (Day 30). Change in PAID-P from post (Day 30) to follow up3 (Month 3). Change in PAID-P from follow up 3 (month 3) to follow up 6 (month 6).

• Change in Self-report diabetes-related variables: diabetes-specific emotional distress (teens)

  Change in PAID-T from pre (Day 1) to post (Day 30). Change in PAID-T from post (Day 30) to follow up3 (Month 3). Change in PAID-T from follow up 3 (month 3) to follow up 6 (month 6).

• Change in Self-report diabetes-related variables: the diabetes family conflict scale (caregivers)

  Change in DFCS from pre (Day 1) to post (Day 30). Change in DFCS from post (Day 30) to follow up3 (Month 3). Change in DFCS from follow up 3 (month 3) to follow up 6 (month 6).

Study Arms (1)

Self compassion intervention

OTHER

4 weeks group and online format self compassion intervention

Other: Psychological intervention (self-compassion based)

Interventions

Psychological intervention (self-compassion based) OTHER

4 weeks intervention for both primary caregivers and adolescents with T1D will be done online through videoconferencing and will be based on three validated protocols that use self-compassion (MSC and MSC Teens).

Self compassion intervention

Eligibility Criteria

• Age: 12 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• have taken care of the management of the patient with diabetes for at least one year since the day of recruitment
• they have access to a personal mobile phone.
• aged 11-15 years old
• diagnosed with T1D more than 12 months ago at the time of recruitment
• they have access to a personal mobile phone.

You may not qualify if:

• non-Spanish native speakers
• presenting developmental or attention deficit disorders (e.g., autism spectrum disorder, ADHD)
• being diagnosed with a serious mental disorder requiring ongoing treatment (e.g., psychosis) or receiving a pharmacological intervention (e.g., depression, anxiety).
• untreated hypothyroidism
• recently (in previous 48 hours of the recruiting process) diagnosed with (a) diabetic ketoacidosis (DKA) or (b) severe hypoglycaemia.

Sponsors & Collaborators

• University of Valencia: lead

Study Sites (1)

University of Valencia

Valencia, 46010, Spain

Location

MeSH Terms

Interventions

Psychosocial Intervention

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Rosa Baños Rivera, PhD

  Univeristy of Valencia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: No blinding can be used however the researcher will be blinded when coding observational data.
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: single case multiple randomized baseline design

Study Record Dates

• First Submitted: October 13, 2021
• First Posted: June 29, 2022
• Study Start: September 6, 2021
• Primary Completion: March 15, 2022
• Study Completion: September 15, 2022
• Last Updated: June 29, 2022

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)