The Cost-efficacy of Psychological Intervention for Strengthening Parental Authority Among Parents of Diabetic Adolescents With Poor Glycemic Control
1 other identifier
interventional
55
1 country
1
Brief Summary
A three arms, open, randomized interventional study including 100 participants in order to evaluate the cost-efficacy of psychological intervention for strengthening parental authority among parents of diabetic adolescents with poor glycemic control. All participants will be randomized into three groups:1.The first group will get a psychological treatment in order to strengthen the parent's authority. 2.The second group will get an education of a nurse and a dietician. 3.The third group will serve as a control group and will not go through an intervention. The following data will be analyzed during the study: 1.Changes in HbA1c. 2.Changes in parents authority. 3.Changes in the diabetes treatment by the adolescents. 4.Consumption of health services. 5.The costs of all psychological treatments.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable diabetes
Started Feb 2008
Longer than P75 for not_applicable diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2008
CompletedFirst Submitted
Initial submission to the registry
February 13, 2008
CompletedFirst Posted
Study publicly available on registry
February 25, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedMay 15, 2018
May 1, 2018
7.5 years
February 13, 2008
May 9, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
HbA1c
Every three months
adherence to treatment
before the intervention, after the intervention and at the end of the study
consumption of health services
during the study and at the end of the study
Secondary Outcomes (1)
Changes in the wellbeing of adolescents and their parents
In the beginning of the study, at the end of the intervention and after 6 months
Study Arms (3)
1
EXPERIMENTALPsychological intervention for strengthening parental authority
2
ACTIVE COMPARATORDiabetes education- 5 sessions with diabetes nurse, taking place once a week
3
NO INTERVENTIONControl group- regular treatment without any intervention
Interventions
Eligibility Criteria
You may qualify if:
- Parents of adolescents between the ages of 10-18
- More than one year diabetes
- Adolescent's HbA1c\>8
You may not qualify if:
- Adolescents or parents of adolescents that are mentally retarded.
- Another chronic disease besides diabetes.
- Adolescents that are taking medications that might disturb their glycemic control.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Schneider Children's Medical Center
Petah Tikva, Israel
Related Publications (1)
Yackobovitch-Gavan M, Meshy-Tamir R, Nagelberg N, Phillip M, Meyerovitch J. Psychosocial factors associated with depressive mood in Israeli obese adolescents. J Health Psychol. 2014 Apr;19(4):574-84. doi: 10.1177/1359105313475901. Epub 2013 Mar 11.
PMID: 23479303DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joseph Meyerovitch, MD
Rabin Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 13, 2008
First Posted
February 25, 2008
Study Start
February 1, 2008
Primary Completion
August 1, 2015
Study Completion
August 1, 2015
Last Updated
May 15, 2018
Record last verified: 2018-05