The impact of implementation of the modified program aggression replacement training on self-efficacy and Glycosylated hemoglobin of adolescents with insulin-dependent diabetes
The aim of this study is to determine the impact of modified program Aggression Replacement Training on self efficacy and glycosylated hemoglobin adolescents with insulin-dependent diabetes. Inclusion criteria are: Aggressive adolescents, Age 12 to 18 years old, last six months of diagnosis of insulin-dependent diabetes and member of parsian diabetic clinic. Exclusion criteria is participates who absent in more than one session. Total of Seventy diabetic adolescents randomly allocated into two groups. control group has no training but intervention group has six sessions of 1/5 to 2 hours modified program aggression replacement training perform. The primary outcome measures includ self-efficacy and glycosylated hemoglobin. Primary outcome time points are beginning of the study and two months after of intervention and primary outcome method of measurement are standard questionnaire of insulin management diabetes self-efficacy scale and glycosylated hemoglobin test. Primary outcome measures, time points and method of measurements is similar in two groups.
General information
Acronym
ART
IRCT registration information
IRCT registration number:IRCT2014122220395N1
Registration date:2015-01-16, 1393/10/26
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-01-16, 1393/10/26
Registrant information
Name
Syed Javad Hoseini
Name of organization / entity
Mashhad Faculty of Nursing and Midwifery
Country
Iran (Islamic Republic of)
Phone
+98 58 3723 2650
Email address
hoseinij911@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2014-11-02, 1393/08/11
Expected recruitment end date
2015-03-20, 1393/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The impact of implementation of the modified program aggression replacement training on self-efficacy and Glycosylated hemoglobin of adolescents with insulin-dependent diabetes
Public title
the Impact of aggression training on self-efficacy and glycosylated hemoglobin patient disease
Purpose
Health service research
Inclusion/Exclusion criteria
Including criteria: aggressive adolescents; last six months of diagnosis of insulin-dependent diabetes; age 12 to 18 years. Exclusion criteria: participates who absent in more than one session.
Age
From 81 years old to 76 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Mashhad Faculty of Nursing and Midwifery, Ebn-e Sina St. Doktora Crossroads.
City
Mashhad
Postal code
Approval date
2014-11-01, 1393/08/10
Ethics committee reference number
930340
Health conditions studied
1
Description of health condition studied
Insulin-dependent diabetes
ICD-10 code
E10
ICD-10 code description
Insulin-dependent diabetes mellitus
Primary outcomes
1
Description
Self efficacy
Timepoint
Beginning of study؛ two months after intervention
Method of measurement
standard questionnaire of insulin management diabetes self-effi cacy scale
2
Description
Glycosylated hemoglobin
Timepoint
Beginning of study؛ two months after intervention
Method of measurement
Glycosylated hemoglobin test
Secondary outcomes
empty
Intervention groups
1
Description
Control group (without training): Includs adolescents with insulin-dependent diabetes; interventions include: pretest with standard questionnaire of insulin management diabetes self-efficacy scale and glycosylated hemoglobin test; post tests: two months after intervention
Category
N/A
2
Description
Intervention group: adolescents with insulin-dependent; intervention include: pretest (standard questionnaire of insulin management diabetes self-efficacy scale and glycosylated hemoglobin test), attend in a six session 1/5 to 2 hours of modified program aggression replacement training؛ post test two months after intervention.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Parsian diabetes clinic
Full name of responsible person
Ali Akbar Raouf
Street address
Shahid Chamran St. Chamran 8
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Faculty of Nursing and Midwifery, Ebn-e Sina St, Doktora Crossing
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad Faculty of Nursing and Midwifery
Full name of responsible person
Sayed Javad Hoseini
Position
MS Nursing/Postgraduate student
Other areas of specialty/work
Street address
Ebn-e Sina St. Doktora Crossing
City
Mashhad
Postal code
Phone
+98 58 3723 2650
Fax
Email
hoseinij911@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad Faculty of Nursing and Midwifery
Full name of responsible person
Seyed Reza Mazlom
Position
PhD
Other areas of specialty/work
Street address
Ebn-e Sina St. Doktora Crossing, Daneshgah Ave
City
Mashhad
Postal code
Phone
+98 51 3859 1511
Fax
Email
mazlomr@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Sayed Javad Hoseini
Position
MS Nursing/Postgraduate student
Other areas of specialty/work
Street address
Ebn-e Sina St. Doktora Crossing
City
Mashhad
Postal code
Phone
00
Fax
Email
hoseinij911@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)