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

NCT ID: NCT05437913

Last Updated: 2022-06-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-06
• Study Completion Date: 2022-09-15

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.

Conditions

Diabetes type1

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Self compassion intervention

4 weeks group and online format self compassion intervention

Group Type: OTHER

Psychological intervention (self-compassion based)

Intervention Type: OTHER

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).

Interventions

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).

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

• 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.

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).

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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Valencia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rosa Baños Rivera, PhD

Role: PRINCIPAL_INVESTIGATOR

Univeristy of Valencia

Locations

University of Valencia

Valencia, , Spain

Countries

Spain

Other Identifiers

SWEET2021

Identifier Type: -

Identifier Source: org_study_id