TEENCOPE: An Internet Coping Skills Training Program for Teens With Type 1 Diabetes - Full Text View

Purpose

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.

Condition	Intervention	Phase
Type 1 Diabetes	Behavioral: TeenCope Behavioral: Managing Diabetes	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	An Internet Coping Skills Training Program for Teens With Type 1 Diabetes

Resource links provided by NLM:

Genetics Home Reference related topics: type 1 diabetes

MedlinePlus related topics: Diabetes Diabetes Type 1

U.S. FDA Resources

Further study details as provided by Yale University:

Primary Outcome Measures:

Hemoglobin A1c (HbA1c) [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Pediatric Quality of Life Inventory (PedsQL) [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Perceived Stress Scale (PSS) [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Self-Efficacy for Diabetes Scale [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Children's Depression Inventory [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Self-Perception Profile for Adolescents [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Responses to Stress Questionaire (RSQ) [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Diabetes Family Behavior Scale [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Self Management of Type 1 Diabetes [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Diabetes Conflict [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Enrollment:	320
Study Start Date:	May 2008
Study Completion Date:	May 2012
Primary Completion Date:	May 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 TeenCope: Internet-based Coping Skills Training	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
Active Comparator: 2 Managing Diabetes: Internet-based Diabetes Education	Behavioral: 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.

Arms

Assigned Interventions

Experimental: 1

TeenCope: Internet-based Coping Skills Training

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

Active Comparator: 2

Managing Diabetes: Internet-based Diabetes Education

Behavioral: 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.

Detailed 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.

Eligibility

Ages Eligible for Study:	11 Years to 14 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00684658

Locations

United States, Arizona
University of Arizona
Tucson, Arizona, United States, 85721
United States, Connecticut
Yale University School of Nursing
New Haven, Connecticut, United States, 06519
United States, Florida
University of Miami
Miami, Florida, United States, 33136
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104

Sponsors and Collaborators

Yale University

National Institute of Nursing Research (NINR)

Investigators

Principal Investigator:	Margaret Grey, DrPh, FAAN, CPNP	Yale School of Nursing
Principal Investigator:	Robin Whittemore, PhD, APRN	Yale School of Nursing

More Information

Publications:

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.

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.

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.

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. Epub 2012 Mar 29.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Whittemore R, Jaser SS, Jeon S, Liberti L, Delamater A, Murphy K, Faulkner MS, Grey M. An internet coping skills training program for youth with type 1 diabetes: six-month outcomes. Nurs Res. 2012 Nov-Dec;61(6):395-404. doi: 10.1097/NNR.0b013e3182690a29.

Jaser SS, Faulkner MS, Whittemore R, Jeon S, Murphy K, Delamater A, Grey M. Coping, self-management, and adaptation in adolescents with type 1 diabetes. Ann Behav Med. 2012 Jun;43(3):311-9.

Responsible Party:	Robin Whittemore, Principal Co-Investigator, Yale University
ClinicalTrials.gov Identifier:	NCT00684658 History of Changes
Other Study ID Numbers:	R01NR004009, R01NR004009
Study First Received:	May 21, 2008
Last Updated:	October 16, 2012
Health Authority:	United States: Federal Government

Keywords provided by Yale University:

Type 1 Diabetes
Children and Teenagers
Coping with Chronic Illness

Adolescence
Internet psychosocial program
Coping Skills Training

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases

Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 19, 2013