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COMPLETED
NCT07886307
NA

Comprehensive Intervention to Promote Adjustment in Adolescents With Type 1 Diabetes and Their Parents During Transfer of Health Care Responsibility

Sponsor: Universidad de la Sabana

View on ClinicalTrials.gov

Summary

Introduction: Type 1 diabetes mellitus is a health condition that produces physical and psychosocial alterations in both the person the person with diabetes mellitus and his or her family, that is why interventions should be designed that make a comprehensive approach to the physiological and psychological aspects of adolescents and parents in order to achieve adaptation to a new normality in the framework of this health condition. Objective: To establish the preliminary efficacy of a comprehensive intervention to promote adaptation in adolescents with type 1 diabetes mellitus and their parents during the transfer of health care responsibility in Bogota, Colombia 2023-2025. Materials and methods: we propose to conduct a pilot study that will develop and evaluate a comprehensive intervention to promote adaptation in adolescents with DM1 and their parents. In the qualitative phase, the needs of adolescents with type 1 diabetes mellitus and their parents will be explored through focus groups. In the quantitative phase, the intervention will be designed and its feasibility, acceptability and preliminary efficacy will be evaluated. A content analysis will be performed on the qualitative data and descriptive and inferential statistical tools will be used for the quantitative data, considering the behavior of the data. Expected results: It is expected to evaluate the preliminary efficacy of a comprehensive intervention to promote adaptation in adolescents with diabetes.

Official title: Comprehensive Intervention to Promote Adjustment in Adolescents With Type 1 Diabetes Mellitus and Their Parents During Transfer of Health Care Responsibility: Feasibility, Acceptability, and Preliminary Efficacy.

Key Details

Gender

All

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

34

Start Date

2025-03-01

Completion Date

2025-12-31

Last Updated

2026-10-21

Healthy Volunteers

No

Interventions

BEHAVIORAL

CONEXIÓN ADAPTAR - DM1

Intervention CONEXIÓN ADAPTAR - DM1, consists of 8 sessions for adolescents and parents, the intervention is delivered in person and virtually and seeks to promote adaptation to type 1 Diabetes.

OTHER

Usual Care

Usual care

Locations (2)

Universidad de La Sabana

Chía, Cundinamarca, Colombia

Universidad de La Sabana

Chía, Colombia