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.: PACTR202203616584913 Date of Approval: 08/03/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Psycho-social support for prevention of perinatal depression
Official scientific title Effectiveness of group-based psycho-education intervention in preventing perinatal depressions by maternal health care providers in primary health care facilities found in Jimma, Oromia, Ethiopia, 2022. A cluster randomized control trial
Brief summary describing the background and objectives of the trial In Ethiopia 1 out of 4 mothers, affected by perinatal depression, which is about two-fold higher than the global prevalence. Evidence highlights, the need for early identification and suitable psychosocial interventions to prevent the damaging effects of perinatal depressions, for this the prenatal period offers maternal health care providers a unique opportunity to identify mothers who are at risk for emotional problems, marital difficulties, poor social support, and coping abilities and provide psycho-social interventions. However, in Ethiopia, there is no assessment and interventions targeted to this problem at maternal health care services. Objective: - To assess the effectiveness of group-based psycho-education intervention in preventing perinatal depressions in primary health care facility by primary health care providers.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) NO
Disease(s) or condition(s) being studied Mental and Behavioural Disorders,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Psychosocial
Anticipated trial start date 02/03/2022
Actual trial start date 28/03/2022
Anticipated date of last follow up 31/08/2022
Actual Last follow-up date 01/10/2022
Anticipated target sample size (number of participants) 640
Actual target sample size (number of participants) 640
Recruitment status Not yet recruiting
Publication URL NOT YET
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 Simple randomization using a randomization table created by a computer software program Numbered containers Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Group based psychoeducation 5 prenatal group sessions lasting 60 to 90 minutes will be administered for all intervention groups every week(For 5 weeks) 5 weeks (60-90 Minutes/week) Definition of perinatal depression and discussion on how its seen and treated /prevented in our community - Risk factors or possible causes of perinatal depression, potential impact on the mother, pregnancy out come, long term effect on baby and family as a whole. -Symptoms to recognize PPD, availability of professional help, when to seek professional help. - self-care activities (prevention methods) -The importance of social support and type of support. - Discussions and experience sharing on how to get social support -One session discussion with partner or family members(for mother who has no partner with them) on the risk of perinatal depressions and purpose of social support in preventing perinatal depressions. 320
Control Group Focused antenatal care...no any intervention given for mothers on MCH for PPD. nothing given ( control arm will receive the existing routine care (Focused antenatal care). Usual care(Four visit but can be more than that based on mother condition ) Focused antenatal care has no any assessment and management or prevention programs in relation to perinatal depression (maternal mental health). 320 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Study participant screening will pass two stage; first mothers gestational age will be assessed (calculated based on their last normal menstrual period (LMNP) and fundal height (combination result will be taken) or directly taken from the card. Then mothers whose gestational age 12-20 weeks will be assessed for their depression status by locally validated tool, patient health questioner-9 (PHQ-9)(Yitbarek Kidane Woldetensay, 2018). Mothers who are normal (score 0-4) and mild (score 5-9) by PHQ-9 will be included in the study. The rest with moderate-severe depression (PHQ-9≥10) in both groups will be referred to nearby hospital psychiatric out patient department, to be further evaluated and treated by district clinician(psychiatrist). Pregnant mothers who are on psychiatric treatment and severely ill at the time of the trial will be excluded from the study Adult: 19 Year-44 Year 15 Year(s) 49 Year(s) Female
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
Yes 14/10/2021 Jimma University Institute of health Institutional review board
Ethics Committee Address
Street address City Postal code Country
Jimma University,Jimma, Ethiopia Jimma 378 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Proportion of mothers who have good social support, post-partum depression literacy, and low post-natal depression at -6-weeks post-partum period. 6 weeks post partum
Secondary Outcome improvements in utilization of preventive maternal and child health care service, healthy life style of the mother and good birth outcome will be the secondary outcome variable. 6 weeks post partum
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Jimma zone primary health care facility Oromia Regional State, Jimma Zone Jimma town 188 Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
Jimma University Jimma University, Jimma, Ethiopia Jimma 378 Ethiopia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Jimma University Jimma University, Jimma, Ethiopia Jimma 378 Ethiopia University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Marta Tessema marta.tessema@gmail.com +2510917391968 Oromia Regional state, Jimma University,
City Postal code Country Position/Affiliation
Jimma Town 378 Ethiopia Ph.D fellow
Role Name Email Phone Street address
Scientific Enquiries Zewdie Birhanu zbkoricha@yahoo.com +251917025852 Jimma University, Oromia, Ethiopia
City Postal code Country Position/Affiliation
Jimma Town 378 Ethiopia Associate Professor
Role Name Email Phone Street address
Public Enquiries Mulumebet Abera mulu_abera.ts2009@yahoo.com +251985171738 Jimma University, Oromia, Ethiopia
City Postal code Country Position/Affiliation
Jimma Town 378 Ethiopia College Dean
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The IPD Reports will have prepared for all baseline and end line study. We plan each of the survey outcome will have published on reputable or impact factor journals. Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Just after 6 month of end line data collection, No end date Anyone who wishes to access the data, for any purpose of data analysis, will have get the trial data without any process of requesting and review process from hands of principal investigator(who decides) or journal publication link.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Do not have wibesite 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