Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202108830911743 Date of Approval: 24/08/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title The interventions on marital relationship
Official scientific title Effectiveness of a marital relationship skill training on marital adjustment among married people in Hosanna town, Southwest Ethiopia: A Randomized Control Trial
Brief summary describing the background and objectives of the trial Background: A marital bond is a holy and divinely established covenant and is found to be the greatest source of happiness and well-being. A good quality marital life has numerous benefits and the most accepted event in any social and spiritual aspects of human life (Glenn, 1979). Beginning from early human history, the continuity of the human race has been made possible due to the relation of male and female as a means of procreation (WHO, 2006). Moreover, children living with their married biological parents also claimed to have better physical, emotional, and academic performance (Linacre Q., 2014). Nevertheless, low-quality marriage pose profoundly long-lasting deleterious health, psychological, and socio-economic impacts (Lin IF., et al., 2019). The previous studies were limited to certain segments of society, and there were uncertainties in findings. Thus, it is important to develop and examine the effectiveness of the proposed interventions and offer abreast options. . Individual Participant Data (IPD) Sharing statement All of the individual data collected during the trial period will be coded and entered into SPSS 23 versions shared to in the manner that does not violate the international and National ethical declarations. This data could be in the report such as in tables and figures. The details of entire study protocol that encompasses statistical analysis plan, informed consent form, clinical code and participant randomization and allocation information will also be shared immediately following publication. The metadata will be submitted to the international journal publishers with the manuscript during the process of evaluation for possible publication. The pertinent data analyzed to achieve the study objective will also be shared. We will share the data to anyone who wishes to access.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) Marital dissolution Divorce Intervention study Training
Disease(s) or condition(s) being studied Mental and Behavioural Disorders
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 30/11/2021
Actual trial start date 10/12/2021
Anticipated date of last follow up 10/06/2023
Actual Last follow-up date 30/06/2022
Anticipated target sample size (number of participants) 80
Actual target sample size (number of participants) 72
Recruitment status Completed
Publication URL . https://doi.org/10.1111/jmft.12641
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Marital relationship skill training Once Five months The proposed intervention in this study is a "Marital relationship skill training intervention" designed to optimize marital relationship among cohort of marital couples. This intervention is planned based on basic facts and assumptions. Conflicts between couples are inevitable and most are functional and managed by educational interventions. From family stress and coping theory, stress is assumed to be normal and disturb the equilibrium that could be maintained by coping. Accordingly, probably this study is the first study in Ethiopia and Africa to address the problems or shortcomings of the earlier studies. We believe that this study is comprehensive and tried to involve all segments of society at large. It is designed to provide new insight into research-based roadmaps of "Marital couples training" that includes the wide-ranging concepts comprehended by considering the spiritual and scientific evidence. The proven theories and models were adapted extensively to make the training sounder. It outlines the basic elements (social, health, legal, and spiritual contexts) of marriage, and dissolution. It is summarized in to four sessions. The first session will encompass "the basics of marriage" the knowledge and understanding of couples on marital life, the meaning of marital union (Bible, Koran, family law), and the benefits of lovely marital life. The second session includes the different “causes and consequences of marital conflict and marital dissolutions. The third session includes the basics of marital life-promoting and conflict resolution skills. That includes, insights into relationship dynamics, principles of commitment and forgiveness. The basics of sensuality and sexuality family politics are also be included in this session. The fourth session includes finalizing the training that encompasses, training evaluation, and certification. This training is estimated to take sixteen hours and ten minutes. 34
Control Group None No Five months Simple observation with the existing system 34 Historical
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Participants having a history of marital dissolution at least for six months Agreed to participate Comply with the schedule Married of any age Live in the Hosanna for at least 6 months duration will satisfy. Unmarried Unable to participate Live less than 6 months in Hosanna Town Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 65 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 24/08/2021 Bahir Dar University Institutional review board
Ethics Committee Address
Street address City Postal code Country
Bahir Dar, Northwest Ethiopia Bahir Dar 0079 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome is marital relationship: The marital relationship that will be examined using the RDAS, a 14-item scale with well-established properties. This study compares the change that occurs between the two; the experimental arm and the comparison or control arm on the marital relationship score. The marital couple training intervention (MaCoTi) will be an independent variable. There will be two groups, the experimental and control arms. The experimental arm will receive this intervention and the control group will not receive this training. The marital relationship score that will be measured using the RDAS at two time periods, before and after the intervention will be interpreted to reflect the effectiveness of the training intervention. Immediately after the intervention and five months after the intervention
Secondary Outcome Marital stability Yearly
Primary Outcome 1. This study will provide a marital couple training package intervention that will underpin a better marital satisfaction and reduce conflicts in the family. 2. A ten to twenty-minute radio and television spots discussing the epidemiology of marital dissolution (the causes & consequences of marital dissolution and possible solutions to attain marital satisfaction) aired on local FM and TV stations once every week. 3. It will provide a sample policy brief that will be approved by content experts 4. Through this, this study will enhance the willingness of the partners, community, governmental and non-governmental organizations working in the era of family health. 5. It will improve marital stability and reduce risks of marital dissolution. After six months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Hosanna Town Southern Ethiopia Hosanna 0159 Ethiopia
Hosanna Health Science College Hosanna, Southwest Ethiopia Hosanna 0159 Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
Self Hosanna College of Health Sciences , Southwest Ethiopia Hosanna 159 Ethiopia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Hosanna College of Health Sciences Hosanna, Southwest Ethiopia Hosanna 0159 Ethiopia University
Secondary Sponsor Bahir Dar University Bahir Dar University, College of Medicine and Health Sciences, School of Public Health, Bahir Dar, Northwest Ethiopia Bahir Dar 0079 Ethiopia University
COLLABORATORS
Name Street address City Postal code Country
Professor Getu Degu Bahir Dar University Bahir Dar 0079 Ethiopia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Likawunt Asfaw samuelliku@gmail.com +251984691515 SNNPR
City Postal code Country Position/Affiliation
Hosanna Ethiopia Hosanna
Role Name Email Phone Street address
Public Enquiries Melese Zewuge melehhhc@gmail.com +251465552315 SNNPR
City Postal code Country Position/Affiliation
Hosanna 0159 Ethiopia College Dean
Role Name Email Phone Street address
Public Enquiries Melesech Lapiso melegyes@gmail.com +251926114379 SNNPR
City Postal code Country Position/Affiliation
Hosanna 0159 Ethiopia HR in Hosanna College of Health Sciences
Role Name Email Phone Street address
Scientific Enquiries Kifle Hajito bethy_kifle@yahoo.com +251471111457 Jimma
City Postal code Country Position/Affiliation
Jimma Ethiopia Professor Jimma University
Role Name Email Phone Street address
Scientific Enquiries Getu Degu adgetu123@yahoo.com +251918776010 Bahir Dar, Northwest Ethiopia
City Postal code Country Position/Affiliation
Bahir Dar 0079 Ethiopia PhD program Coordinator
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual data collected during the trial period will be coded and entered into STATA 14 and SPSS 23 versions shared to in the manner that does not violate the international and National ethical declarations. This data could be in the report such as in tables and figures. The details of entire study protocol that encompasses statistical analysis plan, informed consent form, clinical code and participant randomization and allocation information will also be shared immediately following publication. The metadata will be submitted to the international journal publishers with the manuscript during the process of evaluation for possible publication. The pertinent data analyzed to achieve the study objective will also be shared. We will share the data to anyone who wishes to access the data. Informed Consent Form,Statistical Analysis Plan,Study Protocol Immediately after publication to one year Permission from publishers and PACTR
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information