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

Primary Purpose

Diabetes type1

Status
Active
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Psychological intervention (self-compassion based)
Sponsored by
University of Valencia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Diabetes type1

Eligibility Criteria

12 Years - 15 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria for the caregivers:

  • 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.

Inclusion Criteria for the patients/teens:

  • 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.

General Exclusion Criteria:

  • 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).

Exclusion criteria for teens:

  • untreated hypothyroidism
  • recently (in previous 48 hours of the recruiting process) diagnosed with (a) diabetic ketoacidosis (DKA) or (b) severe hypoglycaemia.

Sites / Locations

  • University of Valencia

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Self compassion intervention

Arm Description

4 weeks group and online format self compassion intervention

Outcomes

Primary Outcome Measures

Change in Self-report psychological variables: depression (caregivers )
- 2 items for caregivers: PHQ-2 (Kroenke, 2003; Spanish version: Wulsin et al., 2002)
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 Self-report psychological variables: self-compassion (caregivers)
- 20 items for caregivers: SOCS-S (Gu et al., 2020); Spanish version back forward translation
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 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 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 Self-report psychological variables: self care (caregivers)
- 24 items for caregivers: B-MSC (Cook-Cottone, 2018); Spanish version back forward translation
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 Self-report psychological variables: interoceptive awareness (caregivers)
- 32 items for caregivers: MAIA-2 (Mehling et al., 2018); Spanish version back forward translation
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

Secondary Outcome Measures

change in metabolic outcome 1 (only teens)
glycated hemoglobin (HbA1c)
change in metabolic outcome 2 (only teens)
continuous glucose monitoring (time in range: TiR)
Change in Self-report diabetes-related variables: diabetes-specific emotional distress (caregivers)
- 14 items: PAID-P (Shapiro et al., 2018); Spanish version back forward translation
Change in Self-report diabetes-related variables: diabetes-specific emotional distress (teens)
- 14 items: PAID-T (Shapiro et al., 2018);Spanish version back forward translation and adapted to teens
Change in Self-report diabetes-related variables: the diabetes family conflict scale (caregivers)
- 8 items: DFCS for caregivers, Hood et al., 2007; Spanish version back forward translation
Change in Self-report diabetes-related variables: the diabetes family conflict scale (teens)
- 8 items: DFCS for teens, Hood et al., 2007; Spanish version back forward translation
Change in Self-report diabetes-related variables: parental report on teen's health-related quality of life
- 10 items: KIDSCREEN-10 (Ravens-Sieberer et al., 2005); Spanish version provided by the same authors
Change in observational behavioural variable (caregiver-teen dyad)
caregiver-adolescent dyadic interaction analysis of neutral and conflictual topic discussion based on Holmbeck et al. (2013) Parent-child interaction macro coding manual (PCIM)
Change in ecological momentary assessment: affect (caregivers)
- 1 item: created by the research team measure of affect sent once per day to participants
Change in ecological momentary assessment: affect (teens)
- 1 item: created by the research team measure of affect sent once per day to participants
Change in ecological momentary assessment self kindness (caregivers )
- 1 item: created by the research team measure of self kindness sent once per day to participants
Change in ecological momentary assessment self kindness (teens)
- 1 item: created by the research team measure of self kindness sent once per day to participants
Change in ecological momentary assessment: self criticism (caregivers)
- 1 item: created by the research team measure of self criticism sent once per day to participants
Change in ecological momentary assessment: self criticism (teens)
- 1 item: created by the research team measure of self criticism sent once per day to participants
Change in ecological momentary assessment: triggering event (caregivers)
- 1 item: created by the research team measure of triggering events where the participants are asked to rate how much a potential negative triggering event affected them. The item was sent once per day to participants
Change in ecological momentary assessment: triggering event (teens)
- 1 item: created by the research team measure of triggering events where the participants are asked to rate how much a potential negative triggering event affected them. The item was sent once per day to participants
Change in ecological momentary assessment: emotion regulation (caregivers )
- 1 item: created by the research team measure of emotion regulation strategies where the participants are asked to chose from the list emotion regulation strategies that they used to regulate the emotions related to the triggering event. The item was sent once per day to participants
Change in ecological momentary assessment: emotion regulation (teens)
- 1 item: created by the research team measure of emotion regulation strategies where the participants are asked to chose from the list emotion regulation strategies that they used to regulate the emotions related to the triggering event. The item was sent once per day to participants
change in ecological momentary assessment: positive impact on caregiver-teen interactions (caregivers and teens)
- 1 item: created by the research team measure of positive impact on parent child interaction where the participants are asked to rate how the triggering event impacted their relationship with (caregiver or child) positively. The item was sent once per day to participants
change in ecological momentary assessment: negative impact on caregiver-teen interactions (caregivers and teens)
- 1 item: created by the research team measure of positive impact on parent child interaction where the participants are asked to rate how the triggering event impacted their relationship with (caregiver or child) negatively. The item was sent once per day to participants
Practice frequency
- 1 item: created by the research team measure of frequency of daily meditation practice
Possible adverse effects
6 item scale developped by the team

Full Information

First Posted
October 13, 2021
Last Updated
June 23, 2022
Sponsor
University of Valencia
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1. Study Identification

Unique Protocol Identification Number
NCT05437913
Brief Title
Protocol for Self-Compassion Intervention for Teens With Diabetes Type 1 and Their Caregivers
Acronym
SWEET
Official Title
Brief Self-Compassion Intervention for Adolescents With Diabetes Type 1 and Their Caregivers: Protocol for a Single Case Multiple-baseline Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 6, 2021 (Actual)
Primary Completion Date
March 15, 2022 (Actual)
Study Completion Date
September 15, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Valencia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Type 1 Diabetes (TD1) has a significant impact on individuals dealing with this chronic metabolic condition, their families and the whole society. A particularly vulnerable group of individuals with TD1 are adolescents. The investigators created a short (4 sessions) self-compassion intervention for adolescents with T1D and their caregivers. Both feasibility and potential clinical effectiveness will be assessed using a single-case, multiple baseline experimental design where psychological, behavioral, and metabolic outcomes will be evaluated at baseline, post intervention, and 3- and 6-months follow ups. Moreover, ecological momentary assessment will be performed daily.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes type1

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
single case multiple randomized baseline design
Masking
None (Open Label)
Masking Description
No blinding can be used however the researcher will be blinded when coding observational data.
Allocation
N/A
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Self compassion intervention
Arm Type
Other
Arm Description
4 weeks group and online format self compassion intervention
Intervention Type
Other
Intervention Name(s)
Psychological intervention (self-compassion based)
Intervention Description
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).
Primary Outcome Measure Information:
Title
Change in Self-report psychological variables: depression (caregivers )
Description
- 2 items for caregivers: PHQ-2 (Kroenke, 2003; Spanish version: Wulsin et al., 2002)
Time Frame
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)
Title
Change in Self-report psychological variables: depression ( teens)
Description
- 2 items for teens: PHQ-2 (Richardson et al., 2010; Spanish version: Arrieta et al., 2017)
Time Frame
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)
Title
Change in Self-report psychological variables: self-compassion (caregivers)
Description
- 20 items for caregivers: SOCS-S (Gu et al., 2020); Spanish version back forward translation
Time Frame
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).
Title
Change in Self-report psychological variables: self-compassion (teens)
Description
- 20 items for teens: SOCS-S (Gu et al., 2020); Spanish version back forward translation and adapted to teens
Time Frame
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).
Title
change in Self-report psychological variables: self-criticism (caregivers)
Description
- 14 items for caregivers: FSCRS-SR (Gilbert, Clarke, Hempel, Miles & Irons, 2004); Spanish version back forward translation
Time Frame
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).
Title
Change in Self-report psychological variables: self-criticism (teens)
Description
- 14 items for teens: FSCRS-SR (Gilbert, Clarke, Hempel, Miles & Irons, 2004); Spanish version back forward translation and adapted to teens
Time Frame
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).
Title
Change in Self-report psychological variables: self care (caregivers)
Description
- 24 items for caregivers: B-MSC (Cook-Cottone, 2018); Spanish version back forward translation
Time Frame
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).
Title
Change in Self-report psychological variables: self care (teens)
Description
- 24 items for teens: B-MSC (Cook-Cottone, 2018); Spanish version back forward translation and adapted to teens
Time Frame
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).
Title
Change in Self-report psychological variables: interoceptive awareness (caregivers)
Description
- 32 items for caregivers: MAIA-2 (Mehling et al., 2018); Spanish version back forward translation
Time Frame
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).
Title
Change in Self-report psychological variables: interoceptive awareness (teens)
Description
- 32 items for teens: MAIA-Y (Joenes et al., 2020); Spanish version back forward translation and adapted to teens
Time Frame
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 Outcome Measure Information:
Title
change in metabolic outcome 1 (only teens)
Description
glycated hemoglobin (HbA1c)
Time Frame
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).
Title
change in metabolic outcome 2 (only teens)
Description
continuous glucose monitoring (time in range: TiR)
Time Frame
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).
Title
Change in Self-report diabetes-related variables: diabetes-specific emotional distress (caregivers)
Description
- 14 items: PAID-P (Shapiro et al., 2018); Spanish version back forward translation
Time Frame
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).
Title
Change in Self-report diabetes-related variables: diabetes-specific emotional distress (teens)
Description
- 14 items: PAID-T (Shapiro et al., 2018);Spanish version back forward translation and adapted to teens
Time Frame
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).
Title
Change in Self-report diabetes-related variables: the diabetes family conflict scale (caregivers)
Description
- 8 items: DFCS for caregivers, Hood et al., 2007; Spanish version back forward translation
Time Frame
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).
Title
Change in Self-report diabetes-related variables: the diabetes family conflict scale (teens)
Description
- 8 items: DFCS for teens, Hood et al., 2007; Spanish version back forward translation
Time Frame
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).
Title
Change in Self-report diabetes-related variables: parental report on teen's health-related quality of life
Description
- 10 items: KIDSCREEN-10 (Ravens-Sieberer et al., 2005); Spanish version provided by the same authors
Time Frame
Change in KIDSCREEN-10 from pre (Day 1) to post (Day 30). Change in KIDSCREEN-10 from post (Day 30) to follow up3 (Month 3). Change in KIDSCREEN-10 from follow up 3 (month 3) to follow up 6 (month 6).
Title
Change in observational behavioural variable (caregiver-teen dyad)
Description
caregiver-adolescent dyadic interaction analysis of neutral and conflictual topic discussion based on Holmbeck et al. (2013) Parent-child interaction macro coding manual (PCIM)
Time Frame
Change in PCIM between pre (Day 1) and post (Day 30).
Title
Change in ecological momentary assessment: affect (caregivers)
Description
- 1 item: created by the research team measure of affect sent once per day to participants
Time Frame
Change between baseline (Day 1-Day11) and post (Day 30-Day 34). Change between post (Day 30-Day 34) and follow up3 (Day 90-Day 104). Change between follow up3 (Day 90-Day 104) and follow up6 (Day 180- Day194).
Title
Change in ecological momentary assessment: affect (teens)
Description
- 1 item: created by the research team measure of affect sent once per day to participants
Time Frame
Change between baseline (Day 1-Day11) and post (Day 30-Day 34). Change between post (Day 30-Day 34) and follow up3 (Day 90-Day 104). Change between follow up3 (Day 90-Day 104) and follow up6 (Day 180- Day194).
Title
Change in ecological momentary assessment self kindness (caregivers )
Description
- 1 item: created by the research team measure of self kindness sent once per day to participants
Time Frame
Change between baseline (Day 1-Day11) and post (Day 30-Day 34). Change between post (Day 30-Day 34) and follow up3 (Day 90-Day 104). Change between follow up3 (Day 90-Day 104) and follow up6 (Day 180- Day194).
Title
Change in ecological momentary assessment self kindness (teens)
Description
- 1 item: created by the research team measure of self kindness sent once per day to participants
Time Frame
Change between baseline (Day 1-Day11) and post (Day 30-Day 34). Change between post (Day 30-Day 34) and follow up3 (Day 90-Day 104). Change between follow up3 (Day 90-Day 104) and follow up6 (Day 180- Day194).
Title
Change in ecological momentary assessment: self criticism (caregivers)
Description
- 1 item: created by the research team measure of self criticism sent once per day to participants
Time Frame
baseline (Day 1-Day11), post (Day 30-Day 34), follow up3 (Day 90-Day 104), and follow up6 (Day 180- Day194)
Title
Change in ecological momentary assessment: self criticism (teens)
Description
- 1 item: created by the research team measure of self criticism sent once per day to participants
Time Frame
Change between baseline (Day 1-Day11) and post (Day 30-Day 34). Change between post (Day 30-Day 34) and follow up3 (Day 90-Day 104). Change between follow up3 (Day 90-Day 104) and follow up6 (Day 180- Day194).
Title
Change in ecological momentary assessment: triggering event (caregivers)
Description
- 1 item: created by the research team measure of triggering events where the participants are asked to rate how much a potential negative triggering event affected them. The item was sent once per day to participants
Time Frame
Change between baseline (Day 1-Day11) and post (Day 30-Day 34). Change between post (Day 30-Day 34) and follow up3 (Day 90-Day 104). Change between follow up3 (Day 90-Day 104) and follow up6 (Day 180- Day194).
Title
Change in ecological momentary assessment: triggering event (teens)
Description
- 1 item: created by the research team measure of triggering events where the participants are asked to rate how much a potential negative triggering event affected them. The item was sent once per day to participants
Time Frame
Change between baseline (Day 1-Day11) and post (Day 30-Day 34). Change between post (Day 30-Day 34) and follow up3 (Day 90-Day 104). Change between follow up3 (Day 90-Day 104) and follow up6 (Day 180- Day194).
Title
Change in ecological momentary assessment: emotion regulation (caregivers )
Description
- 1 item: created by the research team measure of emotion regulation strategies where the participants are asked to chose from the list emotion regulation strategies that they used to regulate the emotions related to the triggering event. The item was sent once per day to participants
Time Frame
Change between baseline (Day 1-Day11) and post (Day 30-Day 34). Change between post (Day 30-Day 34) and follow up3 (Day 90-Day 104). Change between follow up3 (Day 90-Day 104) and follow up6 (Day 180- Day194).
Title
Change in ecological momentary assessment: emotion regulation (teens)
Description
- 1 item: created by the research team measure of emotion regulation strategies where the participants are asked to chose from the list emotion regulation strategies that they used to regulate the emotions related to the triggering event. The item was sent once per day to participants
Time Frame
Change between baseline (Day 1-Day11) and post (Day 30-Day 34). Change between post (Day 30-Day 34) and follow up3 (Day 90-Day 104). Change between follow up3 (Day 90-Day 104) and follow up6 (Day 180- Day194).
Title
change in ecological momentary assessment: positive impact on caregiver-teen interactions (caregivers and teens)
Description
- 1 item: created by the research team measure of positive impact on parent child interaction where the participants are asked to rate how the triggering event impacted their relationship with (caregiver or child) positively. The item was sent once per day to participants
Time Frame
Change between baseline (Day 1-Day11) and post (Day 30-Day 34). Change between post (Day 30-Day 34) and follow up3 (Day 90-Day 104). Change between follow up3 (Day 90-Day 104) and follow up6 (Day 180- Day194).
Title
change in ecological momentary assessment: negative impact on caregiver-teen interactions (caregivers and teens)
Description
- 1 item: created by the research team measure of positive impact on parent child interaction where the participants are asked to rate how the triggering event impacted their relationship with (caregiver or child) negatively. The item was sent once per day to participants
Time Frame
Change between baseline (Day 1-Day11) and post (Day 30-Day 34). Change between post (Day 30-Day 34) and follow up3 (Day 90-Day 104). Change between follow up3 (Day 90-Day 104) and follow up6 (Day 180- Day194).
Title
Practice frequency
Description
- 1 item: created by the research team measure of frequency of daily meditation practice
Time Frame
during the intervention (Day11-Day 30)
Title
Possible adverse effects
Description
6 item scale developped by the team
Time Frame
Change between post (Day 30-Day 34) and follow up3 (Day 90-Day 104). Change between follow up3 (Day 90-Day 104) and follow up6 (Day 180- Day194).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria for the caregivers: 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. Inclusion Criteria for the patients/teens: 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. General Exclusion Criteria: 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). Exclusion criteria for teens: untreated hypothyroidism recently (in previous 48 hours of the recruiting process) diagnosed with (a) diabetic ketoacidosis (DKA) or (b) severe hypoglycaemia.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rosa Baños Rivera, PhD
Organizational Affiliation
Univeristy of Valencia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Valencia
City
Valencia
ZIP/Postal Code
46010
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

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

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