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

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ClinicalTrials.gov Identifier: NCT01191866
Recruitment Status : Unknown
Verified August 2010 by Assaf-Harofeh Medical Center.
Recruitment status was:  Recruiting
First Posted : August 31, 2010
Last Update Posted : August 31, 2010
Sponsor:
Information provided by:
Assaf-Harofeh Medical Center

Tracking Information
First Submitted Date August 29, 2010
First Posted Date August 31, 2010
Last Update Posted Date August 31, 2010
Study Start Date September 2009
Estimated Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Psychosocial Interventions in the Treatment of Youth With Type 1 Diabetes Mellitus
Official Title Intensive Individual and Familial Psychosocial Interventions in the Treatment of Children and Adolescents With Type 1 Diabetes Mellitus
Brief Summary 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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Diabetes Mellitus
Intervention 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
Study Groups/Cohorts Diabetes mellitus
All children and adolescents with type 1 diabetes mellitus attending Assaf Harofeh Pediatric Diabetes Clinic
Intervention: Behavioral: psychosocial intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: August¬†30,¬†2010)
100
Original Estimated Enrollment Same as current
Study Completion Date Not Provided
Estimated Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages up to 18 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Israel
Removed Location Countries  
 
Administrative Information
NCT Number NCT01191866
Other Study ID Numbers 0406
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Dr. Shira Shacham, Assaf Harofeh Pediatric Diabetes Clinic
Study Sponsor Assaf-Harofeh Medical Center
Collaborators Not Provided
Investigators Not Provided
PRS Account Assaf-Harofeh Medical Center
Verification Date August 2010