TEENCOPE: An Internet Coping Skills Training Program fo...

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

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

This study is currently recruiting participants.
Verified by National Institute of Nursing Research (NINR), May 2008
Sponsored by: National Institute of Nursing Research (NINR)

Information provided by: National Institute of Nursing Research (NINR)
ClinicalTrials.gov Identifier: NCT00684658

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 III

MedlinePlus related topics: Diabetes Diabetes Type 1
U.S. FDA Resources
Study Type:Interventional
Study Design:Randomized, Double Blind (Caregiver, Investigator, Outcomes Assessor), Parallel Assignment
Official Title:An Internet Coping Skills Training Program for Teens With Type 1 Diabetes

Further study details as provided by National Institute of Nursing Research (NINR):

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 ]

Diabetes Family Conflict Scale [ 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 ]

Estimated Enrollment:300
Study Start Date:May 2008
Estimated Study Completion Date:May 2012
Estimated Primary Completion Date:May 2012 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Experimental
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 asychronous manner. Youth interact with each other on an online discussion board moderated by a clinical psychologist
2: Active Comparator
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


Contacts
Contact: Lauren Liberti, MS 203-737-5437 lauren.liberti@yale.edu

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

Sponsors and Collaborators
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

Publications:
Whittemore, R., Lindemann, E., Ambrosino, J., Jaser, S., & Grey, M. (2007). Development and pilot of an internet-based CST program for teens with T1D. Diabetes, 56 (Suppl 1), A709-710.
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.

Responsible Party:Yale University School of Nursing ( Lauren Liberti, MS, TeenCope Trial Coordinator )
Study ID Numbers:R01NR004009, R01 NR004009
First Received:May 21, 2008
Last Updated:May 22, 2008
ClinicalTrials.gov Identifier:NCT00684658 [history]
Health Authority:United States: Federal Government

Keywords provided by National Institute of Nursing Research (NINR):
Type 1 Diabetes
Children and Teenagers
Coping with Chronic Illness
Adolescence
Internet psychosocial program
Coping Skills Training

Study placed in the following topic categories:
Autoimmune Diseases
Metabolic Diseases
Diabetes Mellitus, Type 1
Diabetes Mellitus
Endocrine System Diseases
Chronic Disease
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders

Additional relevant MeSH terms:
Immune System Diseases