Clinical trial NCT05437913: Protocol for Self-Compassion Intervention for Teens With Diabetes Type 1 and Their Caregivers
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
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes type1
Lead sponsor: University of Valencia
Sponsor class: OTHER
First posted: 2022-06-29
Enrollment: 8
Sex: ALL
Minimum age (years): 12
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: single case multiple randomized baseline design
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Change in Self-report psychological variables: depression (caregivers )
timeFrame: 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)
measure: Change in Self-report psychological variables: depression ( teens)
timeFrame: 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)
measure: Change in Self-report psychological variables: self-compassion (caregivers)
timeFrame: 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).
measure: Change in Self-report psychological variables: self-compassion (teens)
timeFrame: 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).
measure: change in Self-report psychological variables: self-criticism (caregivers)
timeFrame: 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).
measure: Change in Self-report psychological variables: self-criticism (teens)
timeFrame: 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).
measure: Change in Self-report psychological variables: self care (caregivers)
timeFrame: 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).
measure: Change in Self-report psychological variables: self care (teens)
timeFrame: 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).
measure: Change in Self-report psychological variables: interoceptive awareness (caregivers)
timeFrame: 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).
measure: Change in Self-report psychological variables: interoceptive awareness (teens)
timeFrame: 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:
measure: change in metabolic outcome 1 (only teens)
timeFrame: 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).
measure: change in metabolic outcome 2 (only teens)
timeFrame: 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).
measure: Change in Self-report diabetes-related variables: diabetes-specific emotional distress (caregivers)
timeFrame: 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).
measure: Change in Self-report diabetes-related variables: diabetes-specific emotional distress (teens)
timeFrame: 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).
measure: Change in Self-report diabetes-related variables: the diabetes family conflict scale (caregivers)
timeFrame: 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).
measure: Change in Self-report diabetes-related variables: the diabetes family conflict scale (teens)
timeFrame: 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).
measure: Change in Self-report diabetes-related variables: parental report on teen's health-related quality of life
timeFrame: 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).
measure: Change in observational behavioural variable (caregiver-teen dyad)
timeFrame: Change in PCIM between pre (Day 1) and post (Day 30).
measure: Change in ecological momentary assessment: affect (caregivers)
timeFrame: 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).
measure: Change in ecological momentary assessment: affect (teens)
timeFrame: 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).
measure: Change in ecological momentary assessment self kindness (caregivers )
timeFrame: 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).
measure: Change in ecological momentary assessment self kindness (teens)
timeFrame: 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).
measure: Change in ecological momentary assessment: self criticism (caregivers)
timeFrame: baseline (Day 1-Day11), post (Day 30-Day 34), follow up3 (Day 90-Day 104), and follow up6 (Day 180- Day194)
measure: Change in ecological momentary assessment: self criticism (teens)
timeFrame: 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).
measure: Change in ecological momentary assessment: triggering event (caregivers)
timeFrame: 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).
measure: Change in ecological momentary assessment: triggering event (teens)
timeFrame: 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).
measure: Change in ecological momentary assessment: emotion regulation (caregivers )
timeFrame: 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).
measure: Change in ecological momentary assessment: emotion regulation (teens)
timeFrame: 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).
measure: change in ecological momentary assessment: positive impact on caregiver-teen interactions (caregivers and teens)
timeFrame: 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).
measure: change in ecological momentary assessment: negative impact on caregiver-teen interactions (caregivers and teens)
timeFrame: 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).
measure: Practice frequency
timeFrame: during the intervention (Day11-Day 30)
measure: Possible adverse effects
timeFrame: 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).
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: University of Valencia
Study officials:
affiliation: Univeristy of Valencia
name: Rosa Baños Rivera, PhD
role: PRINCIPAL_INVESTIGATOR
References: