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Trial registered on ANZCTR


Registration number
ACTRN12617001644358
Ethics application status
Approved
Date submitted
17/10/2017
Date registered
19/12/2017
Date last updated
19/12/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effectiveness of a home visitor approach to maternal mental health support and infant stimulation activities for Palestinian on mother and child outcomes
Scientific title
The effectiveness of and enhanced timed and targeted counseling (EttC) model on maternal and child outcomes for Palestinian mothers in West Bank
Secondary ID [1] 293115 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postpartum Depression 305068 0
Infant (Early Childhood) Development 305069 0
Attachment 305070 0
Infant emotional-social wellbeing 305071 0
Parental Knowledge Attitudes and Practices 305072 0
Condition category
Condition code
Mental Health 304386 304386 0 0
Depression
Mental Health 304387 304387 0 0
Studies of normal psychology, cognitive function and behaviour
Reproductive Health and Childbirth 304388 304388 0 0
Childbirth and postnatal care
Diet and Nutrition 304389 304389 0 0
Other diet and nutrition disorders
Public Health 304390 304390 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1 - Intervention
ttC (as described under the control treatment) has been "enhanced" - (thus Enhanced ttC; or EttC) to include improved skills of CHWs to provide psychosocial support to mothers, early identification of perinatal depression and other potential mental health referral needs. EttC additionally includes Early Childhood Development information and key methods, such as supporting mothers and their families to appropriately offer infant stimulation and optimize parent-child attachment during the infant's first 12 months of life.

Materials and resources used for intervention training and delivery:
World Vision International Go-Baby-Go Early Childhood Education Project Model
WHO, WVI, WTF (2011) Psychological first aid: Guide for field workers
World Vision International ttC Home Visitors Toolkit

Between 26 and 30 home visits over a 12-18 month period comprises the control (ttC) and intervention (EttC). Visits begin in the third trimester of pregnancy and are timed according to when key messages are needed for the mother and infant. At a minimum, there are 2 home visits per month, with additional visits prior to birth and in the first 3-months post-delivery. Home visits last approximately one-hour.

Each home visit has a different task and focus, based on the ttC toolkit or the updated EttC home visitation calendar. Both available on request. Each visit comprises a new and timed topic (e.g., pre-birth about exclusive breastfeeding and early infant stimulation; while post-birth it focuses on mother receiving rest and sleep). visits are also adapted according to mother-infant needs, which will be done depending on the critical issues facing mother-infant health.
Intervention code [1] 299359 0
Treatment: Other
Intervention code [2] 299360 0
Prevention
Intervention code [3] 299361 0
Behaviour
Comparator / control treatment
Arm 2 - Control
Timed and Targeted Counseling (ttC) uses trained Community Health Workers (CHWs) to undertake home visits of expectant mothers and provide support to them in the final trimester of pregnancy and thereafter with their infants in the first 12 months of the child’s life. CHWs offer important support, monitoring, information key messages (based on the appropriate timing and need of mother and infant) to the mother, including (but not limited to): antenatal care, breastfeeding, hygiene, potentially harmful care practices, postnatal maternal care (physical and during breastfeeding), infant growth monitoring, immunization, management of common infant illnesses (e.g. diarrhea, cough), complementary feeding and nutrition. Standard ttC has not traditionally focused on maternal mental health or ECD knowledge, attitudes or behaviours, with its focus being largely on the physical wellbeing of mother and child. Between 26 and 30 home visits over a 12-18 month period comprises standard ttC.
Control group
Active

Outcomes
Primary outcome [1] 303631 0
Assessment of Edinburgh Postnatal Depression Scale (EPDS) scores after 1-year for intervention and control groups
Timepoint [1] 303631 0
Endline - when infant reaches 12-months of age (primary timepoint)
Secondary outcome [1] 339708 0
Measures of "‘no-responses" on the Nipissing District Development Screen (NDDS, 2011) after 12 months of intervention or control
Timepoint [1] 339708 0
NDDS measures recorded at multiple timepoints when the infant reaches: 1, 2, 4, 9, 6 and 12 months of age
Secondary outcome [2] 339711 0
Changes in social emotional outcomes in infants will be observed based on the Ages and Stages Questionnaire (ASQ).
Timepoint [2] 339711 0
ASQ measurement at endline only - when infants reach 12 months of age
Secondary outcome [3] 339712 0
Responses to the Early Childhood Development Knowledge, Attitudes and Practices (based on the UNICEF developed ECD-KAP measure) for the intervention and control groups
Timepoint [3] 339712 0
Timepoints: Baseline (recruitment), Midline (infant = 6 months), Endline (infant = 12 months)
Secondary outcome [4] 339713 0
To determine whether there are different impacts on mother and child utilization of other local health services, based on the WHO Client Services Receipt Inventory (WHO SRI).
Timepoint [4] 339713 0
Timepoints for the WHO SRI: Baseline (at recruitment), Midline (infant = 6 months) and Endline (infant = 12 months); however these will also be tracked at each CHW home visit (approximately twice per month for 12 months).
Secondary outcome [5] 340838 0
Changes in social emotional outcomes in infants will be observed based on measures of maternal and infant attachment - First measure at recruitment will use the Maternal Antenatal Attachment Scale (MAAS; Condon, 1993) and at midline and endline, the Maternal Postnatal Attachment Scale (MAPS; Condon & Corkindale, 1998)
Timepoint [5] 340838 0
Baseline (recruitment), Midline (infant = 6-months) and Endline (infant = 12 months)

Eligibility
Key inclusion criteria
Pregnant women in their 3rd trimester and who (a) provide informed consent for participation in the trial; (b) do not show signs of significant cognitive impairment (e.g., dementia, severe mental disorders); and (c) are not at imminent physical, protection or suicide risk.
Minimum age
15 Years
Maximum age
55 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Women who decline involvement in ttC or EttC
Women who decline involvement in the research (although they will still be offered ttC or EttC based on sampling in their area)
Women with significant cognitive impairment
Women with imminent risks of physical complications, protection threats and/or suicide. Such individuals will be re-assessed after the imminent risks have been appropriately managed (e.g., through referrals)

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using villages as "clusters", which were randomly selected to control or intervention condition by "picking them out of a hat".
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Probability of clusters are selected proportional to population size and include all pregnant women in each cluster agreeing to participate in the study. The Edinburgh Postnatal Depression Scale (EPDS) will be the primary outcome measure, expecting women receiving EttC to show mild symptoms of postnatal depression (scores=<9) at baseline compared with women receiving standard ttC (scores=>10). Using Dennis & Hodnett’s (2007) systematic Cochrane review on psychosocial interventions treating postnatal depression, a lower tier effect size of .43 (SD=1) was applied to the calculations. With a standard confidence level of 95% and 80% precision, and assuming equal women in each condition (n=227) is calculated as n=454.
Planned statistical analyses will include means comparisons (t-tests, ANOVA, MANOVA), regression analyses and mediator/moderator model testing

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
6/05/2017
Date of last participant enrolment
Anticipated
Actual
28/08/2017
Date of last data collection
Anticipated
31/08/2018
Actual
Sample size
Target
454
Accrual to date
Final
482
Recruitment outside Australia
Country [1] 9281 0
Palestinian Territory, Occupied
State/province [1] 9281 0
Salfeet, Ramallah, Nablus

Funding & Sponsors
Funding source category [1] 297744 0
Other
Name [1] 297744 0
Grand Challenges Canada
Country [1] 297744 0
Canada
Primary sponsor type
Charities/Societies/Foundations
Name
World Vision International
Address
Executive Office,
1 Roundwood Ave,
Uxbridge UB11 1FG,
United Kingdom
Country
United Kingdom
Secondary sponsor category [1] 296777 0
Charities/Societies/Foundations
Name [1] 296777 0
World Vision Jerusalem, West Bank, Gaza
Address [1] 296777 0
World Vision Jerusalem, West Bank & Gaza Office
Mount of Olives
East Jerusalem
Country [1] 296777 0
Palestinian Territory, Occupied
Secondary sponsor category [2] 296809 0
Charities/Societies/Foundations
Name [2] 296809 0
World Vision Canada
Address [2] 296809 0
1 World Dr,
Mississauga, ON L5T 2Y4,
Canada
Country [2] 296809 0
Canada
Other collaborator category [1] 279770 0
University
Name [1] 279770 0
Al Quds University
Address [1] 279770 0
Al-Quds University,
Main Campus, Abu Dis, P.O Box 89
Telephone: 00972-02-2756200
Country [1] 279770 0
Palestinian Territory, Occupied

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298807 0
Palestinian Health Research Council, Helsinki Committee
Ethics committee address [1] 298807 0
Ethics committee country [1] 298807 0
Palestinian Territory, Occupied
Date submitted for ethics approval [1] 298807 0
30/03/2017
Approval date [1] 298807 0
03/04/2017
Ethics approval number [1] 298807 0
PHRC/HC/202/17

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2228 2228 0 0
/AnzctrAttachments/373807-2017 Helsinki Ethics Committee Approval.pdf (Ethics approval)

Contacts
Principal investigator
Name 78286 0
Ms Hana Rabidi
Address 78286 0
Hana Rabadi Abu Zuluf
Nutrition specialist, MPH
Health and Nutrition Technical Lead
World Vision Jerusalem - West Bank - Gaza
Mount of Olives
Lutheran World Federation Guest House Offices
East Jerusalem
Country 78286 0
Palestinian Territory, Occupied
Phone 78286 0
+972549700749
Fax 78286 0
Email 78286 0
hana.rabidi@wvi.org
Contact person for public queries
Name 78287 0
Hana Rabadi
Address 78287 0
Hana Rabadi Abu Zuluf
Nutrition specialist, MPH
Health and Nutrition Technical Lead
World Vision Jerusalem - West Bank - Gaza
Mount of Olives
Lutheran World Federation Guest House Offices
East Jerusalem
Country 78287 0
Palestinian Territory, Occupied
Phone 78287 0
+972549700749
Fax 78287 0
Email 78287 0
hana_rabidi@wvi.org
Contact person for scientific queries
Name 78288 0
Hana Rabidi
Address 78288 0
Hana Rabadi Abu Zuluf
Nutrition specialist, MPH
Health and Nutrition Technical Lead
World Vision Jerusalem - West Bank - Gaza
Mount of Olives
Lutheran World Federation Guest House Offices
East Jerusalem
Country 78288 0
Palestinian Territory, Occupied
Phone 78288 0
+972549700749
Fax 78288 0
Email 78288 0
hana_rabidi@wvi.org

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.