Multifaceted Intervention Based on Theory of health Action Process Approach to the Health of Divorced female headed-households: Protocol of a Controlled Randomized Trial
Determining the Impact of Multidimensional Intervention Based on Theory of Action Process Approach on the Health of Divorced female headed-households
Design
Randomized controlled trial with parallel groups, one-way blind, randomized by blocking method, with the participation of 100 divorced female-headed households
Settings and conduct
The study will be conducted in Tehran, welfare units. health education in the form of face-to-face and educational video CD based on the theoretical constructs of the health practice process approach for breast self-examination; And in the psycho social field, they will receive CBT family in person and offline application. The results obtained in the two groups of intervention and control are compared immediately after the intervention and three months after the intervention.
Participants/Inclusion and exclusion criteria
Divorced female headed-households - with children - covered by Welfare organization Tehran - no mental health problems and addiction
Intervention groups
Intervention group: Educational intervention sessions in the form of face-to-face and applied-educational application in two physical dimensions (breast self-examination behavior) and psycho-social dimension (mental health and support of family and others)
Control group: without intervention
Main outcome variables
Depression - Anxiety - Breast self - examination and family adoption
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200923048813N1
Registration date:2020-11-15, 1399/08/25
Registration timing:prospective
Last update:2020-11-15, 1399/08/25
Update count:0
Registration date
2020-11-15, 1399/08/25
Registrant information
Name
Farzaneh Golboni
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8145 4462
Email address
f.golboni@behdasht.gov.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-01-20, 1399/11/01
Expected recruitment end date
2021-03-19, 1399/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Multifaceted Intervention Based on Theory of health Action Process Approach to the Health of Divorced female headed-households: Protocol of a Controlled Randomized Trial
Public title
Evaluation of multifaceted intervention on the health of divorced female-headed households
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Divorced female headed-households
covered by welfare
Having children
No history of severe mental illness and addiction
Having Smart phone
Willing to participate
Exclusion criteria:
Drugs or psychotropic substances abuse
Use of psychiatric drugs
Participate in cognitive sessions or similar training sessions
Age
From 20 years old to 60 years old
Gender
Female
Phase
3
Groups that have been masked
Data analyser
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation of participants in two groups will be done by random blocking method with 4 blocks. The block randomization method is such that the allocation sequence is written before the start of the research. Given that the two groups will be studied, 4 blocks are used and each letter is assigned to a group (A: intervention group: B control group). All possible modes are written and numbered for a block of 4. Then, in a simple random method (using a table of random numbers), a number of numbers are selected from the block numbers and by writing the contents of the blocks related to those numbers (until the specified sample size is reached), The random assignment sequence is specified.
Blinding (investigator's opinion)
Single blinded
Blinding description
The analyzer does not know about the groups
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Qazvin University of Medical Sciences
Street address
QAZVIN UNIVERSITY OF MEDICAL SCIENCES -BAHONAR BLV
City
QAZVIN
Province
Qazvin
Postal code
15315-34199
Approval date
2020-07-29, 1399/05/08
Ethics committee reference number
IR.QUMS.REC.1399.121
Health conditions studied
1
Description of health condition studied
Divorced female headed-households`health
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
self breast examination
Timepoint
Immediately after the intervention and 3 month later
Method of measurement
check list
2
Description
depression and anxiety
Timepoint
Immediately after the intervention and 3 month later
Method of measurement
Questionnaire standard of HOST
3
Description
family adaption
Timepoint
Immediately after the intervention and 3 month later
Method of measurement
FACE 3 Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Training with HAPA and CBT Family model for 6 weeks through face-to-face , online with and without application training. Intervention sessions: Interventional training sessions will be designed both in person and offline training application. In this application, approved educational materials in The mentioned areas will be included.content of Education will be evaluated in terms of general criteria such as accuracy, non-contradiction and integrity, clarity, appropriateness to the audience, attractiveness, acceptability and creativity, as well as the content presented in terms of content and presentation of the message. Will take.Educational materials designed before the intervention will be provided to 10 divorced women apart from the sample size to be evaluated in terms of comprehensibility and acceptability. Interventions for divorced women with inclusion criteria will be performed and in the control group will receive only individual cognitive-behavioral training program and two training pamphletsBefore starting the study, in a 2-hour training class, the intervention group and the control group will be taught separately how to work with the application, and the researcher will provide people with their phones to answer any type of question related to the application or other questions. Educational items designed in a very simple and understandable way for clients.CBT Family / CBT training interventions are prepared in three ways online and in the application in the form of video and writing and event recording that at any time a person can use any of the methods that are possible for him. Interventions after 2 hours of application training for Members of the intervention group beginCBT Family training will done in 6 sessions of 1.5 hours and also providing educational package content interventions (educational pamphlet and CD) for the field of reproductive health (breast cancer screening) and 1 45-minute CBT session and educational pamphlet (breast cancer screening) Will receive the control group.The training content is designed based on the Health Action Process Approach model in six half-hour sessions on CD and application in which three training sessions for risk perception structures, expectation of results in the HAPA (Health Action Process Approach) motivational phase and three sessions for the structure Self-efficacy of self-efficacy is designed and the level of awareness before and after training will be completed by the researcher-made questionnaire and checklist made by the individual.Awareness before and after training will be completed by the individual using a questionnaire and a researcher-made checklist. And CBT Family evaluation will be done by recording the data in the application using the standard HADS questionnaire and the adaptation and continuity assessment scale of 3 or 4 FACES family. Finally, the results obtained in the two groups of intervention and control are compared immediately after the intervention and three months after the intervention. First sessions: Familiarity with the participant and explanation of the program Second sessions: Educate the participant about the cognitive-behavioral approach with emphasis on communication skillsThird sessions: Familiarity with negative thoughts and ideas and mental stereotypes about the occurrence of social behaviors and the degree of belief in these thoughtsFourth sessions: Familiarity with spontaneous thoughts in dealing with family and communityFifth sessions: Examining the evidence confirming and rejecting negative beliefs about behavior in the familySixth sessions: Functional analysis and establishing a therapeutic relationshipHAPA-based breast self-examination structures- Action Self-efficacy: Be optimistic about doing the breast self-examination correctly- Outcome expectations: life span And increase the level of reproductive health in the family- Risk perception: Breast loss due to cancer and family loss as well as the prevalence of overhead breast cancer in women- Behavioral intention: Enough motivation to do monthly breast self-examination- Action Plan: Set the schedule and the order of the examination by the person herself- Coping plan: Schedule a proper monthly breast self-examination by the person in the presence of the researcher to ensure that it is done correctly- Self-efficacy: Perform proper breast self-examination by the individualContent of breast self-examination training sessions in the training package (30 minutes each session):- First session: Importance of breast self-examination Meet women and get their awareness of breast cancer risk and its consequences and their awareness of breast cancer screening Risk of late detection of breast cancer and its impact on quality of life and longevity- Second session: The effect of breast self-examination on quality of life Show death statistics for breast cancer Show slides of breast cancer surgeries and their impact on beauty and quality of life and longevity of women- Third session: Preparation of schedule and schedule of breast self-examination by a woman How to plan a monthly breast self-examination during the menstrual cycle or after menopause- Fourth session: Perform breast self-examination in order and step by step from observation to accurate touching of different parts of the breast- Fifth session: Breast self-examination with the help of the researcher's instructions, first all the steps of observation and then the touch stage in two positions in a supine position and then the right lymph nodes and relying on abnormal points that may be found in the examination - practice and eliminate Find out the objections of the researcher and answer the questions and concerns of women- Sixth session: Perform step by step Breast examination View to touch the tissue To examine the lymph nodes Repeat until the stage is done without any problems and completely correct and record the problems related to the examination in each stage in a sheet.Family for 6 weeks through face-to-face training, practical application
Category
Behavior
2
Description
Control group: Get a brief pamphlet and CBT education in one session (1.5 hour)
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Welfare organization of Tehran
Full name of responsible person
Farzaneh Golboni
Street address
Next to the School of Rehabilitation-Shemiran- Enghelab Ave
City
Tehran
Province
Tehran
Postal code
۱۱۳۶۵/۴۱۸۷
Phone
+98 21 7751 0065
Email
f.golboni@behdasht.gov.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr Mohammad Mehdi Emam Jome
Street address
Deputy of Research- Mavadat Allay- Shahjid Beheshti Blvd-Ghazvin
City
Tehran
Province
Tehran
Postal code
13911/34156
Phone
+98 28 3333 7006
Email
research.dpt@qums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Farzaneh Golboni
Position
PhD student
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
S EIslamic Republic of Iran Ministry of Health & Medical Education A bolck -6 floor Eyvanak Shahrak Gharb Tehran -
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۹۴۳۴۷۱
Phone
+98 21 8145 4462
Email
f.golboni@behdasht.gov.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Farzaneh Golboni
Position
PhD candidate
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Ministry of health and medical education- 6 floor - -East Eyvanak- Shahrak Gharb- Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۹۴۳۴۷۱
Phone
+98 21 8145 4462
Email
f.golboni@behdasht.gov.ir
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Farzaneh Golboni
Position
PhD candidate
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Ministry of health and medical education- 6 floor- East Eyvanak- Shahrak Gharb- Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۹۴۳۴۷۱
Phone
+98 21 8145 4462
Email
f.golboni@behdasht.gov.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data can be shared in the form of an article or protocol after unidentifiable
When the data will become available and for how long
one year after article published
To whom data/document is available
students and masters
Under which criteria data/document could be used
only with refernce
From where data/document is obtainable
Qazvin university of medical sciences
What processes are involved for a request to access data/document
request to deputy of research Qazvin university of medical sciences