Clinical Trials/NCT05437913

NCT05437913

Unknown

N/A

Brief Self-Compassion Intervention for Adolescents With Diabetes Type 1 and Their Caregivers: Protocol for a Single Case Multiple-baseline Feasibility Study

University of Valencia1 site in 1 country8 target enrollmentSeptember 6, 2021

ConditionsDiabetes type1

Overview

Phase: N/A
Intervention: Not specified
Conditions: Diabetes type1
Sponsor: University of Valencia
Enrollment: 8
Locations: 1
Primary Endpoint: Change in Self-report psychological variables: self-compassion (teens)
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 6, 2021

End Date

September 15, 2022

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

University of Valencia

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

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.

Outcomes

Primary Outcomes

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

- 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 care (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).

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

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

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)

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

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

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).

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

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

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)

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

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

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).

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

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

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).

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

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

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

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

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).

- 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

Secondary Outcomes

Change in observational behavioural variable (caregiver-teen dyad)(Change in PCIM between pre (Day 1) and post (Day 30).)
Change in ecological momentary assessment self kindness (teens)(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)(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)(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 (caregivers)(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)(baseline (Day 1-Day11), post (Day 30-Day 34), follow up3 (Day 90-Day 104), and follow up6 (Day 180- Day194))
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 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).)
Change in Self-report diabetes-related variables: parental report on teen's health-related quality of life(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 ecological momentary assessment self kindness (caregivers )(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 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 (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 (teens)(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 ecological momentary assessment: affect (teens)(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 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 ecological momentary assessment: negative impact on caregiver-teen interactions (caregivers and teens)(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(during the intervention (Day11-Day 30))
Change in ecological momentary assessment: self criticism (teens)(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 )(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)(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)(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).)
Possible adverse effects(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).)