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Early Childhood DevelopmentNCT03665246

Evaluation of the iMBC/ECD Model in Ghana

A study testing Integrated Mothers and Babies Course in people with Early Childhood Development, run by Duke University at 1 site in Ghana.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The Duke research team will work with Catholic Relief Services (CRS) and lead the design and implementation of a cluster-randomized trial in Northern Ghana to assess the impact of the Integrated Mothers and Babies Course \& Early Childhood Development (iMBC/ECD) intervention on the mental wellbeing of mothers of… Read more about this study

Who is it for?
Ages 16 years and older, women only
Conditions the study is for
Early Childhood Development
What is being tested?
Integrated Mothers and Babies Course
Could I receive a placebo?
No, everyone receives an active treatment
How many people
378 participants
Where
1 siteGhana
Study dates
29 Aug 2018to 26 Feb 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 years and older
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 16 years or older
  • Currently pregnant
  • Attends C-PrES groups at the time of the baseline survey (West Mamprusi and Nabdam District)
  • Plan to maintain residence in the community for at least 6 months
  • Agrees to voluntary participation
  • (The participation of the child falls under the mother's consent. Once born, the child will be followed along with its mother as long as the mother continues participation in the study.)

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Ghana1 site

  • Catholic Relief Services

    Tamale

Other trials in Ghana

About this study

Official title: Evaluation of the iMBC/ECD Model on Maternal Mental Health and Child Development in Ghana

The Duke research team will work with Catholic Relief Services (CRS) and lead the design and implementation of a cluster-randomized trial in Northern Ghana to assess the impact of the Integrated Mothers and Babies Course \& Early Childhood Development (iMBC/ECD) intervention on the mental wellbeing of mothers of children under 2 and their children's attainment of age-appropriate developmental milestones.

Read the detailed description

Maternal psychological disorders around the time of pregnancy and childbirth have been identified as a key risk factor for poor child development outcomes in growth, cognition, and overall child health in low- and middle-income countries (LMICs). Maternal depression during a child's infancy predicts negative behavior and lower achievement scores, as well as increased absences in elementary school), and has been identified as a significant risk factor for poor infant growth in the developing world. There is considerable evidence to suggest that a community-based intervention, delivered by trained community volunteers, can have a significant impact on perinatal depression and child development outcomes. This cluster-randomized trial in Northern Ghana will assess the impact of the Integrated Mothers and Babies Course \& Early Childhood Development (iMBC/ECD) intervention on the mental wellbeing of mothers of children under 2 and their children's attainment of age-appropriate developmental milestones. In Ghana, the iMBC/ECD will be implemented in the context of the Rural Emergency Health Service and Transport project (REST II). A key activity of REST II is Community Pregnancy Surveillance and Targeted Education Sessions (C-PrES). Routine C-PrES is delivered via educational group sessions that promote the adoption of key Maternal, Neonatal and Child Health and Nutrition (MNCHN) behaviors (e.g. newborn care, exclusive breastfeeding, etc.) among pregnant women and mothers of children under age two.

Being tested
Integrated Mothers and Babies Course
Keywords
ECD, maternal mental health, early childhood development, Ghana, ASQ, SRQ20, Integrated Mothers and Babies Course, maternal and child health

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Integrated Mothers and Babies CourseBehavioural

    The Integrated Mothers and Babies Course/Early Childhood Development (iMBC/ECD) will be implemented along side normal C-PrES programming (key MNCHN behaviors). The iMBC curriculum is a prevention model based on cognitive behavioral therapy with the aim of supporting pregnant women and mothers with children under two years of age to become more resilient, decrease risk for future depression, and manage daily stressors effectively. In addition, the updated version of the iMBC is integrated with selected early childhood development (ECD) messages. The integration of these messages is intended to increase mothers' knowledge of the stressors associated with pregnancy and parenting young children and promote early stimulation behaviors and bonding to support child development.

Study groups in NCT03665246
Study groupRoleWhat they receive
Intervention (iMBC/ECD + C-PrES)ExperimentalThe intervention group of women/children dyads who consent will receive 14 sessions of the Integrated Mothers and Babies Course/Early Childhood Development (iMBC/ECD) curriculum in addition to the C-PrES curriculum. Upon completion of 14 sessions, women will continue to receive MNCHN and ECD messages and group-based iMBC booster sessions every 3 months.
Receives: Behavioral: Integrated Mothers and Babies Course
Control (C-PrES)No interventionThe control group of women/children dyads who consent will have exposure to 14 sessions of the C-PrES curriculum which promotes the adoption of key MNCHN behaviors (e.g. newborn care, exclusive breastfeeding, etc.). Upon completion of 14 sessions, women will continue to receive MNCHN and ECD messages.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Age-appropriate Social-Emotional Development of Children Under 2 Years

    The Ages and Stages Questionnaire:Social Emotional-2 (ASQ: SE-2) will be used to assess the attainment of age-appropriate social emotional development. The questionnaire that is administered is based on the child's age in completed months:

    • ASQ:SE 2 Month Questionnaire: 1 month 0 days - 2 months 30 days
    • ASQ:SE 6 Month Questionnaire: 3 month 0 days - 8 months 30 days
    • ASQ:SE 12 Month Questionnaire: 9 months 0 days - 14 months 30 days
    • ASQ:SE 18 Month Questionnaire: 15 months 0 days - 20 months 30 days
    • ASQ:SE 24 Month Questionnaire: 21 months 0 days - 26 months 30 days

    Measured: 6 months post-intervention

  2. Maternal Depression/Anxiety

    The 9 item Patient Health Questionnaire (PHQ-9) will be used to asses the mental health (depression) of mothers of children under 2. The PHQ-9 score ranges from 0-27, with higher numbers indicating higher levels of depression.

    Measured: 6 months post-intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Sep 2018
  2. Study start29 Aug 2018
  3. Primary completion26 Feb 2020
  4. Study completion26 Feb 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
The present study is a cluster randomized trial (CRT) of 32 program groups with 16 groups randomly assigned to receive the intervention program (iMBC/ECD + C-PrES) and 16 groups randomly assigned to receive the control program (C-PrES only).The main reason for including randomization is to reduce the risk of selection bias. The unit of inference for this CRT is at the individual level but the unit of randomization is the C-PrES group (cluster) level due to issues of program feasibility.
Masking
None (open label)
Enrolment
378 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03665246
Sponsor's protocol ID
2019-0020
Status last verified
Jul 2020
First submitted
20 Aug 2018
Last updated
24 Jul 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Cao J, Gallis JA, Ali M, Lillie M, Abubakr-Bibilazu S, Adam H, McEwan E, Awoonor-Williams JK, Hembling J, Baumgartner JN. The impact of a maternal mental health intervention on intimate partner violence in Northern Ghana and the mediating roles of social support and couple communication: secondary analysis of a cluster randomized controlled trial. BMC Public Health. 2021 Nov 4;21(1):2010. doi: 10.1186/s12889-021-12121-9.

    PubMed 34736452

  • Mackness J, Gallis JA, Owusu RK, Ali M, Abubakr-Bibilazu S, Adam H, Aborigo R, Awoonor-Williams JK, Lillie M, McEwan E, Hembling J, Vasudevan L, Baumgartner JN. Prevalence and correlates of maternal early stimulation behaviors during pregnancy in northern Ghana: a cross-sectional survey. BMC Pregnancy Childbirth. 2021 Jan 4;21(1):4. doi: 10.1186/s12884-020-03476-9.

    PubMed 33397319

Questions about this trial

What is this clinical trial studying?

A study testing Integrated Mothers and Babies Course in people with Early Childhood Development, run by Duke University at 1 site in Ghana.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Ghana. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Age-appropriate Social-Emotional Development of Children Under 2 Years (time frame: 6 months post-intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03665246, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2020.

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