Type 1 Diabetes Clinical Trial
Official title:
An Internet Coping Skills Training Program for Teens With Type 1 Diabetes
The purpose of the study is to compare the effects of a 5-week internet-based coping skills training program (TeenCope) with a 5-week internet education program (Managing Diabetes) in youth (age 11-14) with type 1 diabetes on intensive insulin therapy.
It is well established that for many youth with type 1 diabetes (T1D), the developmental
stage of puberty is characterized by a significant deterioration in metabolic control.
Previous research conducted by the Yale School of Nursing demonstrates that providing
cognitive-behavioral coping skills training program (CST) as a supplement to intensive
medical treatment regimen enhances physiological and psychosocial outcomes - most notably in
youth as they approach adolescence. Successful CST programs studied at Yale consist of
weekly, in-person group sessions over a 5-week period conducted by a clinical psychologist or
social worker.
Rapid advances in technology have made the internet a compelling tool to reach out to youth
and significantly broaden the application of CST programs. Investigators at Yale (scientists,
NPs, clinical psychologists) have teamed with web specialists (computer programmers, web
designers, graphic artists, and illustrators) and youth with T1D and their parents to adapt
the successful CST program for use on the internet. In this trial, internet-based CST
(TeenCope) will be evaluated by comparing it to an internet-based education program for
managing diabetes (Managing Diabetes).
Three hundred (300) youth from 4 different sites within the U.S will take part in the study.
Youth will be randomly assigned to complete either the TeenCope or Managing Diabetes program
right away, and will be given the opportunity to complete the alternate program after 12
months. Data on psychosocial and disease management parameters will be collected at baseline,
3, 6, 12 and 18 months through youth filling out online questionnaires (lasting approximately
30 minutes). Clinical outcome data (height, weight, HbA1c, episodes of hypoglycemia, DKA, and
hospitalization) will be collected from the medical chart throughout the study, and parents
will complete a demographic data form.
This study has great potential for working with youth with type 1 diabetes. If proven
effective, the investigators are interested in continued dissemination and translation of
this intervention beyond their geographical location.
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