The effect of a need-based program providers on stress, anxiety, depression and burden of caring families of children with attention deficit hyperactivity disorder
The aim of this study was to determine the effect of requiring providers based on stress, anxiety, depression and burden of family caregivers.Inclusion criteria: Family caregiver to be considered as primary care and all have to assume his responsibilities؛ The family have a mental and physical ability to take care of children with ADHD؛ wishing to participate in the study؛ be able to communicate and follow the rules of the training session؛Only care chronic condition like ADHD in the family؛able to speak؛read and write in Persian language؛ psychiatric drug and no drug is not consumed؛ In family training sessions (any other research project in the field) have not participated in the past؛ Care for children who range in age from 7-12 years (school age) and because of ADHD have at least one hospitalization. Children is not affected with any disease (physical disabilities, mental, autism, etc.). Exclusion criteria: family caregiver are not want to continue to participate in the training sessions؛ there is any problem, so be careful not to be able to continue to participate in the study؛ look out for a maximum of two sessions of the training sessions absence؛ The physical and psychological problems in family caregivers who can not presence in the meetings.
This clinical trial study on 70 caregiver of children with ADHD .After easy sampling to qualify for inclusion samples randomly into two case and control groups.The case group will received 8 sessions in need-based training program and The control group will participated in two group sessions and to express their problems and experiences.Due to the compatibility of the primary outcome of this study, caregivers can reduce stress and anxiety and depression, as well as reduce the caregiver of burden.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201611232200N4
Registration date:2016-12-30, 1395/10/10
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-12-30, 1395/10/10
Registrant information
Name
Saeid Pahlavanzadeh
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1772 7861
Email address
pahlavanzadeh@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2016-07-22, 1395/05/01
Expected recruitment end date
2016-08-22, 1395/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of a need-based program providers on stress, anxiety, depression and burden of caring families of children with attention deficit hyperactivity disorder
Public title
The effect of a need-based program on stress, anxiety, depression and care giver burden of families with children having attention deficit hyperactivity disorder
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Family caregiver to be considered as primary care and all have to assume his responsibilities؛ The family have a mental and physical ability to take care of children with ADHD؛ wishing to participate in the study؛ be able to communicate and follow the rules of the training session؛Only care chronic condition like ADHD in the family؛able to speak؛read and write in Persian language؛ psychiatric drug and no drug is not consumed؛ In family training sessions (any other research project in the field) have not participated in the past؛ Care for children who range in age from 7-12 years (school age) and because of ADHD have at least one hospitalization. Children is not affected with any disease (physical disabilities, mental, autism, etc.). Exclusion criteria: family caregiver are not want to continue to participate in the training sessions؛ there is any problem, so be careful not to be able to continue to participate in the study؛ look out for a maximum of two sessions of the training sessions absence؛ The physical and psychological problems in family caregivers who can not presence in the meetings.
Age
From 7 years old to 12 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)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
School of Nursing and Midwifery, Isfahan University of Medical Sciences
Street address
Hezar jarib street, Azadi Sq Esfahan Esfahan Iran, Islamic Republic Of
City
Esfahan
Postal code
Approval date
2016-03-01, 1394/12/11
Ethics committee reference number
IR.MUI.REC.1394.1.194
Health conditions studied
1
Description of health condition studied
attention deficit hyperactivity disorder
ICD-10 code
F90
ICD-10 code description
Hyperkinetic disorders
Primary outcomes
1
Description
caregiver burden,Stress, anxiety, depression
Timepoint
Before, immediately after, a month after the intervention
Method of measurement
DASS & Zarit caregiver burden Questionnaire
Secondary outcomes
1
Description
quality of life
Timepoint
Before the intervention, after the intervention, one month after the intervention
Method of measurement
QOL Questionnaire
Intervention groups
1
Description
control group participated in 2 session
Category
Other
2
Description
Researcher set her intervention based on need-based program such as a supportive intervention in 8 sessions (on average) 75 minute classes for school-age children are family members (problems caused by this disorder this age range are more prominent) who are qualified to do.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra Hospital
Full name of responsible person
Saeid Pahlavanzadeh
Street address
City
esfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Ashraf Kazemi
Street address
Hezar jarib St, Azadi Sq
City
Esfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan 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
Isfahan University of Medical Sciences
Full name of responsible person
Saied Pahlavanzadeh
Position
Master of Science in Psychiatric Nursing / Registered Psychiatric Nursing and Midwifery Faculty
Other areas of specialty/work
Street address
Hezar jarib St, Azadi Sq
City
Isfahan
Postal code
Phone
+98 31 3668 7124
Fax
Email
pahlavanzadeh@nm.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Saied Pahlavanzadeh
Position
Master of Science in Psychiatric Nursing / Registered Psychiatric Nursing and Midwifery Faculty
Other areas of specialty/work
Street address
Hezar jarib St, Azadi Sq
City
Isfahan
Postal code
Phone
+98 31 3668 7124
Fax
Email
pahlavanzadeh@nm.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Saied Pahlavanzadeh
Position
Master of Science in Psychiatric Nursing / Registered Psychiatric Nursing and Midwifery Faculty
Other areas of specialty/work
Street address
Hezar jarib St, Azadi Sq
City
Isfahan
Postal code
Phone
+98 31 3668 7124
Fax
Email
pahlavanzadeh@nm.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)