Condition category
Mental and Behavioural Disorders
Date applied
09/04/2018
Date assigned
09/05/2018
Last edited
16/04/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Malawi has the fifth highest adolescent fertility rate in Africa at 145 births per 1000 girls aged 15 to 19 and is ranked 10th globally by the International Center for Research on Women. Teenage girls are not prepared for motherhood and as a result this can have harmful effects on the development of their children. These teenage mothers lack psychosocial support to better enable them to be mothers so as to improve outcome of children. The study provides critical evidence as to the importance of psychosocial support to teenage mothers and on what support mothers require to better cope with motherhood.
This study aims to improve early child development in children born to teenage mothers by identifying factors that can improve development and providing support to positively impact the development, growth and nutrition of children.

Who can participate?
Mothers under 18 years old

What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group receive a bi-weekly program of psychosocial support, in both individual and group sessions. Babies receive nutritional supplements and are engaged in activities to stimulate growth and bonding with the mothers, in safe baby corners. Participants may also receive counseling.
They are followed up with questionnaires and knowledge assessment before they start the program, and after 1 and 2 years.

What are the possible benefits and risks of participating?
Participants may benefit from improved development of their children. There are no direct risks for those taking part in the study.

Where is the study run from?
The following regions in Malawi:
1. Machinga
2. Mulanje
3. Blantyre

When is the study starting and how long is it expected to run for?
July 2017 to June 2019

Who is funding the study?
Grand Challenges Canada (Canada)

Who is the main contact?
1. Ms Nettie Dzabala (Scientific)
dzabalan@gmail.com
2. Dr Mtisunge Kachingwe (Public)
mtkachingwe@gmail.com

Trial website

https://ywcamalawi.com/blog-posts/

Contact information

Type

Scientific

Primary contact

Ms Nettie Dzabala

ORCID ID

Contact details

P.O Box 2447
Blantyre
N/A
Malawi
+265 991 807 268
dzabalan@gmail.com

Type

Public

Additional contact

Dr Mtisunge Kachingwe

ORCID ID

Contact details

P.O. Box 2447
Blantyre
N/A
Malawi
+265 995 542 832
mtkachingwe@gmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

P.05/17/2178

Study information

Scientific title

Community model for fostering health and wellbeing for adolescent mothers & their children

Acronym

Study hypothesis

Our innovation takes a comprehensive, community led holistic approach with a focus on poor resourced areas in Malawi, where the prevalence of child marriages is high. The target group ismarginalized married girls, pregnant girls, and adolescent mothers. The intervention focuses on creating an enabling and responsive environment for improved health outcomes for young mothers and their babies. This study aims to see improved early child development in babies and well-being of marginalized married adolescent pregnant girls and young mothers in Malawi.

Ethics approval

College of Medicine Ethics Committee University of Malawi, 27/09/2017, ref: P.05/17/2178

Study design

Analytical quantitative and qualitative prospective case-control design

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Community

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Child development

Intervention

The study introduces an intervention to the teenage mothers to show the importance of psychosocial support and how this can improve development growth and children in the children. This research project takes a holistic approach that includes local communities, the government, and local health services.
Almost 65 service providers are trained to provide strategic partnerships created with local communities, the Ministry of Health, Ministry of Gender, the College of Medicine and local health services, ECD centers and legal centers with a strong referral network to offer psychosocial support (PSS).
Participants are randomly allocated to an intervention or control group. Those in the intervention group receive an intervention that focuses on creating an enabling and responsive environment for improved health outcomes for young mothers and their babies for one year. Starting from the individual, relevant psychosocial support (with well tested tools and approaches) is offered to the young mothers and their babies on a weekly basis. This includes biweekly group sessions on learning about caring for oneself – physically, emotionally, spiritually, socially and mentally in a safe space http://www.worldywca.org/wp-content/uploads/2014/02/Safe-Spaces-long-web.pdf.
The babies are given nutritional supplements and are engaged in activities that stimulate growth, as well as bonding with the mothers. Safe baby corners are created where baby stimulation for improved health outcomes take place bi weekly.
With a focus on gender and intimate partner violence, monthly counseling is offered by a professional social worker.
Those in the control group start to receive the intervention after one year.

Intervention type

Supplement

Phase

Drug names

Primary outcome measure

Babies
1. Motor skills are measured using developmental milestones questionnaire at baseline, after 1 year and 2 years
2. Cognitive functions are measured using developmental milestone questionnaire at baseline, after 1 year and 2 years
3. Expressive language are measured using developmental milestone questionnaire at baseline, after 1 year and 2 years
4. Social emotional capacities are measured using developmental milestone questionnaire at baseline, after 1 year and 2 years

Adolescent mothers & pregnant girls
1. Knowledge about psycho social support, maternal and newborn health care practices, sexual reproductive health and rights, HIV and gender equality is assessed.
2. Confidence and psychosocial well-being are assessed using the following questionnaires; Brief resilience scale, Rosenberg self-esteem scale and Parental stress scale at baseline, after 1 year and 2 years

Health workers
Knowledge about psychosocial support and friendly maternal health care services at health centres is assessed using pre and post training questionnaires and follow up interviews at 1 year and 2 years.

Secondary outcome measures

1. Babies development is monitored via the health passport at baseline, 1 year and 2 years.
2. The number of participants trained in parenting skills, nutrition, child care, sexual reproductive health and rights, HIV and gender equality is measured using attendance registers at year 1 and year 2
3. Psychosocial wellbeing of the participants and babies is recorded using the hero book.

Overall trial start date

30/07/2017

Overall trial end date

30/06/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Mothers below the age of 18 years old
2. In antenatal period or with children below the age of 5

Participant type

Other

Age group

Other

Gender

Female

Target number of participants

290 young women

Participant exclusion criteria

Aged 18 years and above

Recruitment start date

17/10/2017

Recruitment end date

27/10/2017

Locations

Countries of recruitment

Malawi

Trial participating centre

Machinga
N/A
Malawi

Trial participating centre

Mulanje
N/A
Malawi

Trial participating centre

Blantyre
N/A
Malawi

Sponsor information

Organisation

Grand Challenges Canada (Through Saving Brains)

Sponsor details

MaRs Centre
South Tower
101 College street
suite 406
Toronto
M5G1L7
Canada
+1 416 673 6568
info@grandchallanges.ca

Sponsor type

Government

Website

www.grandchallenges.ca

Funders

Funder type

Government

Funder name

Grand Challenges Canada

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The project will comprise two publications, in the first year the project focuses on comparing outcomes in the control group versus the cases. In the second year the focus is on outcomes of the control group to see if there is a greater impact as compared to first year. It will work to follow outcomes of the cases from the first year.
Intended publication posted on open access website as well as the Malawi medical journal. Results will be shared with various audiences to engage them into the conversation on maternal and new-born health and to ensure long term impact of the project. Results will be presented to the ministry of health, clinics, health centers, pediatricians, communities and universities at various events and in various forms as well as COMREC. (College of Medicine Ethics Committee)

IPD sharing statement:
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

31/12/2018

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes