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

Diabetes type1 Clinical Trial

— 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05437913
• Other study ID #: SWEET2021
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 6, 2021
• Est. completion date: September 15, 2022

Study information

• Verified date: November 2021
• Source: University of Valencia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 8
• Est. completion date: September 15, 2022
• Est. primary completion date: March 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 15 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Diabetes type1

Intervention

Other:
• Psychological intervention (self-compassion based)
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).

Locations

Country	Name	City	State
Spain	University of Valencia	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
University of Valencia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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).
Primary	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).
Primary	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).
Primary	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).
Primary	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).
Primary	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).
Primary	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).
Primary	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	change in metabolic outcome 1 (only teens)	glycated hemoglobin (HbA1c)	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).
Secondary	change in metabolic outcome 2 (only teens)	continuous glucose monitoring (time in range: TiR)	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).
Secondary	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 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).
Secondary	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 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).
Secondary	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 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).
Secondary	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 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).
Secondary	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 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).
Secondary	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 PCIM between pre (Day 1) and post (Day 30).
Secondary	Change in ecological momentary assessment: affect (caregivers)	- 1 item: created by the research team measure of affect sent once per day to participants	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).
Secondary	Change in ecological momentary assessment: affect (teens)	- 1 item: created by the research team measure of affect sent once per day to participants	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).
Secondary	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 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).
Secondary	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 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).
Secondary	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	baseline (Day 1-Day11), post (Day 30-Day 34), follow up3 (Day 90-Day 104), and follow up6 (Day 180- Day194)
Secondary	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 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).
Secondary	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 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).
Secondary	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 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).
Secondary	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 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).
Secondary	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 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).
Secondary	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 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).
Secondary	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	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).
Secondary	Practice frequency	- 1 item: created by the research team measure of frequency of daily meditation practice	during the intervention (Day11-Day 30)
Secondary	Possible adverse effects	6 item scale developped by the team	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).