A new system in the community for assisting well being in young mothers and their children

ISRCTN	ISRCTN15712529
DOI	https://doi.org/10.1186/ISRCTN15712529
Protocol serial number	P.05/17/2178
Sponsor	Grand Challenges Canada (Through Saving Brains)
Funder	Grand Challenges Canada

Submission date: 09/04/2018
Registration date: 09/05/2018
Last edited: 04/10/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Contact information

Ms Nettie Dzabala
Scientific

P.O Box 2447
Blantyre
N/A
Malawi

Phone	+265 991 807 268
Email	dzabalan@gmail.com

Dr Mtisunge Kachingwe
Public

P.O. Box 2447
Blantyre
N/A
Malawi

Phone	+265 995 542 832
Email	mtkachingwe@gmail.com

Study information

Primary study design	Interventional
Study design	Analytical quantitative and qualitative prospective case-control design
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Community model for fostering health and wellbeing for adolescent mothers & their children
Study objectives	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(s)	College of Medicine Ethics Committee University of Malawi, 27/09/2017, ref: P.05/17/2178
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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.
Completion date	30/06/2019

Eligibility

Participant type(s)	Other
Age group	Other
Sex	Female
Target sample size at registration	290
Key inclusion criteria	1. Mothers below the age of 18 years old 2. In antenatal period or with children below the age of 5
Key exclusion criteria	Aged 18 years and above
Date of first enrolment	17/10/2017
Date of final enrolment	27/10/2017

Locations

Countries of recruitment

Malawi

Study participating centres

Machinga

N/A
Malawi

Mulanje

N/A
Malawi

Blantyre

N/A
Malawi

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Data sharing statement to be made available at a later date
IPD sharing plan	The data sharing plans for the current study are unknown and will be made available at a later date.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		24/03/2021	09/08/2022	Yes	No
Results article		26/02/2021	04/10/2022	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes

Editorial Notes

04/10/2022: Publication reference added.
09/08/2022: Publication reference added.
14/06/2019: Internal review.