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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
8
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).
University of Valencia
Valencia, Spain
Change in Self-report psychological variables: depression (caregivers )
\- 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)
Change in Self-report psychological variables: depression ( teens)
\- 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)
Change in Self-report psychological variables: self-compassion (caregivers)
\- 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).
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
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).
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
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).
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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
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).
Change in Self-report psychological variables: self care (caregivers)
\- 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).
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
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).
Change in Self-report psychological variables: interoceptive awareness (caregivers)
\- 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).
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
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).
change in metabolic outcome 1 (only teens)
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).
change in metabolic outcome 2 (only teens)
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).
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
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).
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
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).
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
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).
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
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).
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
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).
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)
Time frame: Change in PCIM between pre (Day 1) and post (Day 30).
Change in ecological momentary assessment: affect (caregivers)
\- 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).
Change in ecological momentary assessment: affect (teens)
\- 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).
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
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).
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
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).
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
Time frame: baseline (Day 1-Day11), post (Day 30-Day 34), follow up3 (Day 90-Day 104), and follow up6 (Day 180- Day194)
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
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).
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
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).
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
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).
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
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).
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
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).
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
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).
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
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).
Practice frequency
\- 1 item: created by the research team measure of frequency of daily meditation practice
Time frame: during the intervention (Day11-Day 30)
Possible adverse effects
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).