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A Psychosocial Education Programme for Young People With Type 1 Diabetes - the Youth Empowerment Skills (YES)

NCT04670198 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2023-10-06

No results posted yet for this study

Summary

Adolescence is a period of intense physiological, psychological and social change. It can be a challenging period for young people with Type 1 diabetes and is associated with worsening blood sugar control and care disengagement. The investigators have co-designed with young people a psychologically modelled educational programme - Youth Empowerment Skills (YES), which aims to facilitate a positive adaption to living with diabetes while improving knowledge and self-management behaviours. Integrated programme components include social and peer-based learning, immersive simulations, and an outreach youth worker.

The aim of this study is to test the feasibility of the YES programme (acceptance, implementability, recruitment and completion), and estimate its efficacy in relation to metabolic and psychosocial outcomes. The investigators will recruit young people with Type 1 diabetes and conduct a feasibility randomised controlled trial (waiting-list design) with integrated process evaluation. Sixty young people will be randomised to either YES intervention or waiting-list control and evaluate outcomes at 6-months; at this point the waiting list participants will be offered the YES intervention with further follow-up at 12 months.

Conditions

  • Diabetes Mellitus, Type 1

Interventions

BEHAVIORAL

Youth Empowerment Skills

The Youth Empowerment Skills (YES) programme is a novel psychoeducational intervention with simulation-based experiential learning tailored to the needs of young people. It is based on a social-cognitive learning model, and comprises attendance at 3 all-day YES sessions in non-healthcare settings (groups of 10); and then post-programme networking through social media and follow-up events facilitated by the youth worker. Sessions are led by a peer-educator and a health professional

BEHAVIORAL

Waiting-list control

Usual care for 6 months, followed by the YES programme.

Sponsors & Collaborators

  • Guy's and St Thomas' NHS Foundation Trust

    collaborator OTHER

  • Diabetes UK

    collaborator OTHER

  • King's College London

    lead OTHER

Principal Investigators

  • Angus Forbes · King's College London

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
14 Years
Max Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-01
Primary Completion
2023-03-31
Completion
2023-03-31

Countries

  • United Kingdom

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04670198 on ClinicalTrials.gov