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Psychosocial Interventions in the Treatment of Youth With Type 1 Diabetes Mellitus

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by Assaf-Harofeh Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier:
NCT01191866
First received: August 29, 2010
Last updated: August 30, 2010
Last verified: August 2010
History of Changes
  Purpose

Primary Objective is to evaluate the influence of psychosocial interventions in the treatment of children and adolescents with type 1 diabetes mellitus by measuring the connection between these interventions to quality of life and to metabolic control. Secondary Objective is to provide an opportunity, through quality of life (QOL) questionnaires, for enhanced communication between the patient, family and diabetes care team and also an opportunity to resolve negative issues.


Condition Intervention
Diabetes Mellitus
 Behavioral: psychosocial intervention

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Intensive Individual and Familial Psychosocial Interventions in the Treatment of Children and Adolescents With Type 1 Diabetes Mellitus

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Assaf-Harofeh Medical Center:

Estimated Enrollment: 100
Study Start Date: September 2009
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Diabetes mellitus
All children and adolescents with type 1 diabetes mellitus attending Assaf Harofeh Pediatric Diabetes Clinic
 Behavioral: psychosocial intervention
The interventions will include an art therapist, a social worker and volunteer work under the supervision of a diabetes nurse. These therapies will be given to selected patients based on individual needs. We will use existing questionnaires in order to identify problematic areas and quantify quality of life

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All children and adolescents with type 1 diabetes mellitus attending Assaf Harofeh Pediatric Diabetes Clinic will be eligible for inclusion in the study.

Criteria

Inclusion Criteria:

  • All children and adolescents with type 1 diabetes mellitus attending Assaf Harofeh Pediatric Diabetes Clinic will be eligible for inclusion in the study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01191866

Locations
Israel
Assaf Harofeh Pediatric Diabetes Clinic Recruiting
Zerifin, Israel, 70300
Contact: Shacham         shirashacham1@gmail.com    
Principal Investigator: Shira Shacham, MD            
Sponsors and Collaborators
Assaf-Harofeh Medical Center
  More Information

No publications provided

Responsible Party: Dr. Shira Shacham, Assaf Harofeh Pediatric Diabetes Clinic
ClinicalTrials.gov Identifier: NCT01191866     History of Changes
Other Study ID Numbers: 0406
Study First Received: August 29, 2010
Last Updated: August 30, 2010
Health Authority: Israel: Ministry of Health

Keywords provided by Assaf-Harofeh Medical Center:
diabetes mellitus
psychosocial
metabolic control
 quality of life questionnaires
children
adolescents

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 October 17, 2012