TEENCOPE: An Internet Coping Skills Training Program for Teens With Type 1 Diabetes

Type 1 Diabetes Clinical Trial

Official title:

An Internet Coping Skills Training Program for Teens With Type 1 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00684658
• Other study ID #: 0711003291
• Secondary ID: R01NR004009
• Status: Completed
• Phase: Phase 3
• Start date: May 2008
• Est. completion date: May 2012

Study information

• Verified date: March 2020
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 320
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 11 Years to 14 Years

Eligibility

Inclusion Criteria:

• Age 11-14

• English speaking

• Youth assents and parent consents to participation

• School grade is appropriate to age within 1 year

• Type 1 diabetes for a minimum of 6 months

• Access to high speed internet service for 5 week intervention (will be arranged by study if not presently in the home)

Exclusion Criteria:

• Other significant chronic health problems requiring intensive self-management

• Previous exposure to Yale School of Nursing's Coping Skills Training or Managing Diabetes materials

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Behavioral:
• TeenCope
Teencope consists of a series of 5 sessions designed to increase children's sense of competence and mastery by retraining inappropriate or non-constructive coping styles and forming more positive styles and patterns of behavior. Each week a new 30-45 minute session is uploaded to a password-protected website on the Yale server for youth to complete. Youth are grouped with 8-12 peers who complete the same weekly sessions in an asynchronous manner. Youth interact with each other on an online discussion board moderated by a clinical psychologist
• Managing Diabetes
Managing Diabetes consists of 5 sessions on educational content related to diabetes self management targeted to adolescents. As with the TeenCope program, each week a new 30-45 minute session is uploaded to a password-protected website on the Yale server for youth to complete. Youth complete educational sessions independently over 5 weeks. There is no online discussion board or peer interaction.

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida
United States	Yale University School of Nursing	New Haven	Connecticut
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	University of Arizona	Tucson	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

References & Publications (4)

Grey M, Boland EA, Davidson M, Li J, Tamborlane WV. Coping skills training for youth with diabetes mellitus has long-lasting effects on metabolic control and quality of life. J Pediatr. 2000 Jul;137(1):107-13. — View Citation

Grey M, Boland EA, Davidson M, Yu C, Sullivan-Bolyai S, Tamborlane WV. Short-term effects of coping skills training as adjunct to intensive therapy in adolescents. Diabetes Care. 1998 Jun;21(6):902-8. — View Citation

Grey M, Whittemore R, Liberti L, Delamater A, Murphy K, Faulkner MS. A comparison of two internet programs for adolescents with type 1 diabetes: design and methods. Contemp Clin Trials. 2012 Jul;33(4):769-76. doi: 10.1016/j.cct.2012.03.012. Epub 2012 Mar 29. — View Citation

Whittemore R, Grey M, Lindemann E, Ambrosino J, Jaser S. Development of an Internet coping skills training program for teenagers with type 1 diabetes. Comput Inform Nurs. 2010 Mar-Apr;28(2):103-11. doi: 10.1097/NCN.0b013e3181cd8199. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin A1c (HbA1c)		18 months
Primary	Pediatric Quality of Life Inventory (PedsQL)		18 months
Secondary	Perceived Stress Scale (PSS)		18 months
Secondary	Self-Efficacy for Diabetes Scale		18 months
Secondary	Children's Depression Inventory		18 months
Secondary	Self-Perception Profile for Adolescents		18 months
Secondary	Responses to Stress Questionaire (RSQ)		18 months
Secondary	Diabetes Family Behavior Scale		18 months
Secondary	Self Management of Type 1 Diabetes		18 months
Secondary	Diabetes Conflict		18 months