Overall Objective:Determining the Effectiveness of Group Hope Therapy on Self-efficacy(SE) of Adolescents with Type1 Diabetes (T1D) Referred to Isfahan Endocrine and Metabolism Research Center(IEMRC) in 2019
Design
Randomized, not blinded, parallel clinical trial with control group
Settings and conduct
The study is done in IEMRC. Intervention Group will have 8, 90minute training sessions based on SHTP which is presented in Lecture, question and answer, role-playing and homework in groups and face-to-face training using PowerPoint, film and image and the Control Group will receive no training sessions based on SHTP. they receive only routine diabetes self-care training provided by the center itself. Consent and SE questionnaire are completed by participants at the beginning, immediately after the intervention and two months after, then data of sessions are given to all participants.
Participants/Inclusion and exclusion criteria
T1D, Age of 13to19 years, At least 6months passed since diagnosis, Consent of subjects and their parents, Not participating in other psychotherapy programs during this study, Lack of other physical and mental illness, Lack of crisis and severe mental stress in the past 6months
Intervention groups
experimental group will have training sessions based on the Snyder's Hope Therapy Program(SHTP), and no intervention for Control group.
Main outcome variables
amount of Self Efficacy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190813044520N1
Registration date:2020-04-12, 1399/01/24
Registration timing:retrospective
Last update:2020-04-12, 1399/01/24
Update count:0
Registration date
2020-04-12, 1399/01/24
Registrant information
Name
Nasim Nikbakhtan Esfahani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3380 3511
Email address
nasim.nikbakhtan@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-23, 1398/06/01
Expected recruitment end date
2019-10-22, 1398/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effectiveness of Group Hope Therapy on Self-efficacy of Adolescents with Type 1 Diabetes
Public title
The Effectiveness of Hope Therapy on Self-efficacy of Adolescents with Diabetes
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Type 1 diabetes
The age of 13 to 19 years
At least 6 months passed since diagnosis of type 1 diabetes
The satisfaction of sample subjects and their parents with research participation
Exclusion criteria:
having other physical illness
having mental illness and crisis and severe mental stress in the past 6 months
Age
From 13 years old to 19 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
For random allocation of the samples, their names are written on paper cards and then put in a box. The names are then randomly selected by the researcher. The first one is in the experimental group and the second one is in the control group and so on until all of the cards are selected. In this way, participants do not know whether they are in the Experimental or control group.
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
Ethic committee of Isfahan University of Medical Science
Street address
Building No. 4, Isfahan University of Medical Science, Hezarjirib Ave., Isfahan
City
Isfahan
Province
Isfehan
Postal code
81745319
Approval date
2019-09-17, 1398/06/26
Ethics committee reference number
IR.MUI.RESEARCH.REC.1398.365
Health conditions studied
1
Description of health condition studied
Type 1 Diabetes
ICD-10 code
E10
ICD-10 code description
Type 1 diabetes mellitus
Primary outcomes
1
Description
Self Efficacy Scale measured by Diabetes Management Self-Efficacy Scale (DMSES) and Self–Efficacy Questionnaire –Children (SEQ-C)
Timepoint
before and immediately after the intervention and two months after the intervention
Method of measurement
Diabetes Management Self-Efficacy Scale (DMSES) and Self–Efficacy Questionnaire –Children (SEQ-C)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention group will participant in 8, 90-minute training sessions which is held in educational classes of IERC and based on SHTP 2002. Content is provided by the researcher who has passed a Teaching Hope Therapy program and has a valid degree. Content is performed through lectures, question-and-answer, role-playing and practical home works in group and educating face-to-face using PowerPoint, film, image and then sharing them in a Whats app Group. 1st session: Initial familiarity, articulation of study goals and definition of hope based on Snyder's theory. 2nd session:Explaining how hope develops and its necessity, its effect on hopelessness and feeling of emptiness, the importance of hope in life. 3rd session:Telling the life story of each group members, make them notice their strengths and capability. 4th session:reformatting people's stories based on Snyder's Hope Theory, identifying members' past hopes and successes. 5th session:telling and writing a list of current life events and their important aspects for each member and making them determine their importance and satisfaction. 6th session: Goal setting features in hopeful people based on Snyder's Hope Theory and encouraging participants to write their own goals. 7th session: The characteristics of appropriate pathways and pathways to goal and ways to increase hope are described. 8th session:there will be an overview chat about interventions and strategies for how to be and stay motivated.At the end of the course, each member will report the home works and share their comments with other members.
Category
Behavior
2
Description
Control group:The Control group will have no intervention about hope therapy and they receive only routine diabetes self-care training provided by the center itself.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan Endocrine and Metabolism Research Center
Full name of responsible person
Mansour Siavash
Street address
Khorram St, Jomhouri-e-Eslami Square, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8187698191
Phone
+98 31 3335 9933
Fax
+98 31 3337 3733
Email
emrc@mui.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Isfahan university of medical science
Street address
Building No 4, Isfahan University of Medical Science, Hezarjirib Ave, Isfahan
City
Isfahan
Province
Isfehan
Postal code
81745319
Phone
+98 31 3792 3078
Email
resrec@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?