Early Childhood DevelopmentSUpErCDZNCT03991182
Evaluation of Scaling Up Early Childhood Development in Zambia
A study testing SMAGs trained on ECD curriculum, Head women trained on ECD curriculum and Head women led parent groups in people with Early Childhood Development, run by Boston University at 3 sites in Zambia.
Trial summary
In Zambia, 40% of children under five years of age are stunted and 6% are wasted. While the Zambian government has focused on child nutrition in recent years, more focus on holistically improving early child development (ECD) is needed. Read more about this study
- Who is it for?
- Ages 0 months and olderHealthy volunteers can take part
- Conditions the study is for
- Early Childhood Development
- What is being tested?
- SMAGs trained on ECD curriculum, Head women trained on ECD curriculum and Head women led parent groups
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,108 participants
- Where
- 3 sitesZambia
- Study dates
- 20 Sep 2019to 31 Jan 2022
- 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 0 months and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Children aged 0-5 months at baseline in the catchment areas of the ten selected health facilities in Southern and Eastern Provinces will be eligible to participate
- Child's primary caregiver must be 15 years or older
- Child's primary caregiver must be a female (because the participants in the women's group may feel uncomfortable discussing certain issues if a man is present)
- A member of the health facility staff at a study site for at least 6 months; or
- A district or provincial level health staff; or
- A SMAG member at a study site who has been trained to implement the parenting group intervention; or
Show all 10Show fewer
- A 'head mother' leading parenting group sessions within their communities; and ≥18 years of age and provided informed consent to participate in the IDI.
- A woman or a man with child under 3 years of age; or
- Community health volunteers [SMAG, community health worker (CHW) or TBA]; and
- Resident within the project zones; and -≥18 years of age
Who cannot join
- Caregivers who are unwilling to provide informed consent
- Families that plan to move from their health center catchment zone during the period of the study
- In-depth interviews (IDI)
- -None
- Focus group discussions (FGDs)
- -None
Trial locations and contacts
3 sites in 1 country.
Zambia3 sites
Choma District Medical Office
Choma, Southern Province
Kalomo District Medical Office
Kalomo, Southern Province
Nyimba District Medical Office
Nyimba, Eastern Province
About this study
In Zambia, 40% of children under five years of age are stunted and 6% are wasted. While the Zambian government has focused on child nutrition in recent years, more focus on holistically improving early child development (ECD) is needed. Through a previous randomized controlled trial, the investigators developed a community-based parenting intervention and demonstrated that this intervention can improve children's developmental outcomes in Zambia, including nutritional status and their early language development. During fortnightly group meetings, parents learn a diverse curriculum that includes content on: 1) cognitive stimulation and play practices; 2) child nutrition and cooking practices; and 3) self-care for good mental health. This information and learning content is delivered by supervised community volunteers using an interactive theatre-based approach.
In this study, the newly established maternity waiting homes (MWHs) and affiliated Safe Motherhood Action Group leaders (SMAGs) will be used as a novel platform to launch and support community-based parenting groups, embedding this program directly into the existing health system, and making them more feasible for scale-up and sustainability.
Despite the positive impact of the proposed parenting-group model in the pilot trial, this model is not currently operating in Zambia. By integrating this intervention into the existing health system, large populations of rural children exposed to high levels of adversity in the critical early years of life could be reached in a nationally scalable fashion. As part of this project, the investigators propose to implement and rigorously assess the impact of this approach in four districts of Zambia.
Read the detailed description
This research will utilize a cluster-randomized controlled trial with integrated mixed-methods process evaluation to understand the impact of parenting groups on child development outcomes when delivered at scale. The specific objectives are to: 1) assess the impact of the intervention on early childhood development outcomes; 2) assess the degree to which the intervention was implemented according to the project plan and to document adjustments made during the course of the project; 3) describe and document the perceptions of caregivers on parent groups, as well as any behavioral changes in parenting or in mother support networks resulting from participating in parenting groups; and approaches to achieving caregiving gender equality at household level; and, 4) generate a set of recommendations for the Government of the Republic of Zambia to further adapt and/or scale up community parenting groups based on the summative findings from this study.
For the impact evaluation the investigators will collect data from two main sources: 1) Household Surveys and 2) In-depth interviews at both baseline and endline data collection. In addition, at endline we will assess child development using the Malawi Developmental Assessment Tool (MDAT).
For the process evaluation, the investigators will conduct record review of parenting groups attendance registers and SMAG log books. The investigators will conduct in-depth interviews with health systems staff (province, district and health facility), SMAGs, and head women from all intervention sites, and focus group discussions with caregivers who meet the study eligibility criteria in both intervention and control zones.
- Conditions
- Early Childhood Development
- Being tested
- SMAGs trained on ECD curriculum, Head women trained on ECD curriculum, Head women led parent groups, Usual care of children 0-5 months
- Keywords
- Community based parenting, Developmental outcomes, Maternity waiting homes (MWHs), Safe Motherhood Action Group leaders (SMAGs), Zambia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMAGs trained on ECD curriculumOther
50 volunteers (primarily SMAGs- Safe Motherhood Action Group members) associated with the health facility will be trained using a training -of-trainers approach on the e ECD (early childhood development) curriculum
Head women trained on ECD curriculumOther
Each of the 50 trained SMAGs will train 10 head women on the ECD curriculum
Head women led parent groupsBehavioural
Every two weeks 500 trained head women lead parent group meetings on childhood development and nutrition to caregiver-child dyads
Usual care of children 0-5 monthsOther
The traditional care and education of caregivers/parents for children 0-5 months
| Study group | Role | What they receive |
|---|---|---|
| Community-based parenting group | Experimental | The community-based parenting group will include 39 health zones and 585 caregiver-child dyads Receives: Other: SMAGs trained on ECD curriculum; Other: Head women trained on ECD curriculum; Behavioral: Head women led parent groups |
| Control group | Active comparator | The control group will include 39 health zones and 585 caregiver-child dyads Receives: Other: Usual care of children 0-5 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child linear growth: Stunting
Heights of all study children will be measured. Height-for-age z-scores will be calculated using standard World Health Organization (WHO) criteria. Stunting will be defined as having a height-for-age z-score < -2. The difference in the prevalence of stunting between children in the intervention and comparison areas will be determined.
Measured: Children aged 0-5 months at baseline (August-September 2019) and end line (September 2021), child aged 24-29 months
Child development z-scores based on Malawi Developmental Assessment Tool (MDAT)
Cognitive function measurements
Measured: At endline (child aged 24-29 months) children are assessed using the MDAT. Scores are standardized within the study sample for analysis.
Caregiver Reported Early Development Index
Summary score of child development measures (motor, cognitive, language, and social emotional skills)
Measured: Children aged 0-5 months at baseline (August-September 2019) and end line (September 2021), child aged 24-29 months
Secondary outcomes (5)
Proportion of children receiving all age-appropriate vaccines
We will collect data at baseline and endline on whether the study children are up to date on vaccines as recommended by the government vaccination schedule.
Measured: Baseline (child 0-5 months), Endline (child aged 24-29 months)
Proportion of children receiving vitamin A supplementation
Caregivers will be asked about vitamin A supplementation and responses will be compared to child development outcomes
Measured: Baseline (child 0-5 months), Endline (child aged 24-29 months)
Number of well-baby visits attended
Caregivers will be asked about the health seeking behaviors for the child; results will be compared against government recommendations and against child development outcomes
Measured: Baseline (child 0-5 months), Endline (child aged 24-29 months)
Average time spent reading with the child
Caregivers will be asked about their engagement with the child and other adult engagement with the child at baseline and endline
Measured: Baseline (child 0-5 months), Endline (child aged 24-29 months)
Average time spent playing with the child
Caregivers will be asked about their engagement with the child and other adult engagement with the child at baseline and endline
Measured: Baseline (child 0-5 months), Endline (child aged 24-29 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2019
- Study start20 Sep 2019
- Primary completion30 Nov 2021
- Study completion31 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Early Childhood DevelopmentStudies of the same condition, open and under way.
- More trials run by Boston UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Masking
- None (open label)
- Enrolment
- 1,108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Collaborators
- Right to Care Zambia (RTCZ), Swiss Tropical & Public Health Institute, United States Agency for International Development (USAID), Grand Challenges Canada
- Responsible party
- Sponsor
- Investigators
- Nancy A Scott, DrPH MPH, Principal investigator, Boston UniversityThandiwe Ngoma, Principal investigator, Right to Care - Zambia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03991182
- Sponsor's protocol ID
- H-38950
- Other IDs
- TTS-1802-21377, 72061119FA00001
- Acronym
- SUpErCDZ
- Status last verified
- Aug 2023
- First submitted
- 14 Jun 2019
- Last updated
- 16 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rockers PC, Zanolini A, Banda B, Chipili MM, Hughes RC, Hamer DH, Fink G. Two-year impact of community-based health screening and parenting groups on child development in Zambia: Follow-up to a cluster-randomized controlled trial. PLoS Med. 2018 Apr 24;15(4):e1002555. doi: 10.1371/journal.pmed.1002555. eCollection 2018 Apr.
PubMed 29689045Rockers PC, Fink G, Zanolini A, Banda B, Biemba G, Sullivan C, Mutembo S, Silavwe V, Hamer DH. Impact of a community-based package of interventions on child development in Zambia: a cluster-randomised controlled trial. BMJ Glob Health. 2016 Nov 22;1(3):e000104. doi: 10.1136/bmjgh-2016-000104. eCollection 2016.
PubMed 28588962Scott NA, Kaiser JL, Vian T, Bonawitz R, Fong RM, Ngoma T, Biemba G, Boyd CJ, Lori JR, Hamer DH, Rockers PC. Impact of maternity waiting homes on facility delivery among remote households in Zambia: protocol for a quasiexperimental, mixed-methods study. BMJ Open. 2018 Aug 10;8(8):e022224. doi: 10.1136/bmjopen-2018-022224.
PubMed 30099401
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Scaling Up Early Childhood Development in Zambia
- ClinicalTrials.gov ID
- NCT03991182
- Acronym / sponsor ID
- SUpErCDZ / H-38950
- Conditions
- Early Childhood Development
- Keywords
- Community based parenting, Developmental outcomes, Maternity waiting homes (MWHs), Safe Motherhood Action Group leaders (SMAGs), Zambia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,108 participants (actual)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Collaborators
- Right to Care Zambia (RTCZ), Swiss Tropical & Public Health Institute, United States Agency for International Development (USAID), Grand Challenges Canada
- Study start
- 20 Sep 2019 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 19 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In Zambia, 40% of children under five years of age are stunted and 6% are wasted. While the Zambian government has focused on child nutrition in recent years, more focus on holistically improving early child development (ECD) is needed. Through a previous randomized controlled trial, the investigators developed a community-based parenting intervention and demonstrated that this intervention can improve children's developmental outcomes in Zambia, including nutritional status and their early language development. During fortnightly group meetings, parents learn a diverse curriculum that includes content on: 1) cognitive stimulation and play practices; 2) child nutrition and cooking practices; and 3) self-care for good mental health. This information and learning content is delivered by supervised community volunteers using an interactive theatre-based approach.
In this study, the newly established maternity waiting homes (MWHs) and affiliated Safe Motherhood Action Group leaders (SMAGs) will be used as a novel platform to launch and support community-based parenting groups, embedding this program directly into the existing health system, and making them more feasible for scale-up and sustainability.
Despite the positive impact of the proposed parenting-group model in the pilot trial, this model is not currently operating in Zambia. By integrating this intervention into the existing health system, large populations of rural children exposed to high levels of adversity in the critical early years of life could be reached in a nationally scalable fashion. As part of this project, the investigators propose to implement and rigorously assess the impact of this approach in four districts of Zambia.
Detailed description
This research will utilize a cluster-randomized controlled trial with integrated mixed-methods process evaluation to understand the impact of parenting groups on child development outcomes when delivered at scale. The specific objectives are to: 1) assess the impact of the intervention on early childhood development outcomes; 2) assess the degree to which the intervention was implemented according to the project plan and to document adjustments made during the course of the project; 3) describe and document the perceptions of caregivers on parent groups, as well as any behavioral changes in parenting or in mother support networks resulting from participating in parenting groups; and approaches to achieving caregiving gender equality at household level; and, 4) generate a set of recommendations for the Government of the Republic of Zambia to further adapt and/or scale up community parenting groups based on the summative findings from this study.
For the impact evaluation the investigators will collect data from two main sources: 1) Household Surveys and 2) In-depth interviews at both baseline and endline data collection. In addition, at endline we will assess child development using the Malawi Developmental Assessment Tool (MDAT).
For the process evaluation, the investigators will conduct record review of parenting groups attendance registers and SMAG log books. The investigators will conduct in-depth interviews with health systems staff (province, district and health facility), SMAGs, and head women from all intervention sites, and focus group discussions with caregivers who meet the study eligibility criteria in both intervention and control zones.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Community-based parenting group | Experimental | Other: SMAGs trained on ECD curriculum, Other: Head women trained on ECD curriculum, Behavioral: Head women led parent groupsThe community-based parenting group will include 39 health zones and 585 caregiver-child dyads |
| Control group | Active comparator | Other: Usual care of children 0-5 monthsThe control group will include 39 health zones and 585 caregiver-child dyads |
Who may qualify
- Ages
- 0 months and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Children aged 0-5 months at baseline in the catchment areas of the ten selected health facilities in Southern and Eastern Provinces will be eligible to participate
- Child's primary caregiver must be 15 years or older
- Child's primary caregiver must be a female (because the participants in the women's group may feel uncomfortable discussing certain issues if a man is present)
- A member of the health facility staff at a study site for at least 6 months; or
- A district or provincial level health staff; or
Key exclusion criteria (6 listed)
- Caregivers who are unwilling to provide informed consent
- Families that plan to move from their health center catchment zone during the period of the study
- In-depth interviews (IDI)
- -None
- Focus group discussions (FGDs)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SMAGs trained on ECD curriculum50 volunteers (primarily SMAGs- Safe Motherhood Action Group members) associated with the health facility will be trained using a training -of-trainers approach on the e ECD (early childhood development) curriculum | Other | Community-based parenting group |
| Head women trained on ECD curriculumEach of the 50 trained SMAGs will train 10 head women on the ECD curriculum | Other | Community-based parenting group |
| Head women led parent groupsEvery two weeks 500 trained head women lead parent group meetings on childhood development and nutrition to caregiver-child dyads | Behavioural | Community-based parenting group |
| Usual care of children 0-5 monthsThe traditional care and education of caregivers/parents for children 0-5 months | Other | Control group |
Primary outcome
Child linear growth: Stunting
Time frame: Children aged 0-5 months at baseline (August-September 2019) and end line (September 2021), child aged 24-29 months
Heights of all study children will be measured. Height-for-age z-scores will be calculated using standard World Health Organization (WHO) criteria. Stunting will be defined as having a height-for-age z-score < -2. The difference in the prevalence of stunting between children in the intervention and comparison areas will be determined.
Child development z-scores based on Malawi Developmental Assessment Tool (MDAT)
Time frame: At endline (child aged 24-29 months) children are assessed using the MDAT. Scores are standardized within the study sample for analysis.
Cognitive function measurements
Caregiver Reported Early Development Index
Time frame: Children aged 0-5 months at baseline (August-September 2019) and end line (September 2021), child aged 24-29 months
Summary score of child development measures (motor, cognitive, language, and social emotional skills)
5 secondary outcomes
Proportion of children receiving all age-appropriate vaccines
Time frame: Baseline (child 0-5 months), Endline (child aged 24-29 months)
Proportion of children receiving vitamin A supplementation
Time frame: Baseline (child 0-5 months), Endline (child aged 24-29 months)
Number of well-baby visits attended
Time frame: Baseline (child 0-5 months), Endline (child aged 24-29 months)
Average time spent reading with the child
Time frame: Baseline (child 0-5 months), Endline (child aged 24-29 months)
Average time spent playing with the child
Time frame: Baseline (child 0-5 months), Endline (child aged 24-29 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2023.
- Background: PubMed 29689045Rockers PC, Zanolini A, Banda B, Chipili MM, Hughes RC, Hamer DH, Fink G. Two-year impact of community-based health screening and parenting groups on child development in Zambia: Follow-up to a cluster-randomized controlled trial. PLoS Med. 2018 Apr 24;15(4):e1002555. doi: 10.1371/journal.pmed.1002555. eCollection 2018 Apr.
- Background: PubMed 28588962Rockers PC, Fink G, Zanolini A, Banda B, Biemba G, Sullivan C, Mutembo S, Silavwe V, Hamer DH. Impact of a community-based package of interventions on child development in Zambia: a cluster-randomised controlled trial. BMJ Glob Health. 2016 Nov 22;1(3):e000104. doi: 10.1136/bmjgh-2016-000104. eCollection 2016.
- Background: PubMed 30099401Scott NA, Kaiser JL, Vian T, Bonawitz R, Fong RM, Ngoma T, Biemba G, Boyd CJ, Lori JR, Hamer DH, Rockers PC. Impact of maternity waiting homes on facility delivery among remote households in Zambia: protocol for a quasiexperimental, mixed-methods study. BMJ Open. 2018 Aug 10;8(8):e022224. doi: 10.1136/bmjopen-2018-022224.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nancy A Scott, DrPH MPH principal investigator
Boston University
Thandiwe Ngoma principal investigator
Right to Care - Zambia
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SMAGs trained on ECD curriculum, Head women trained on ECD curriculum and Head women led parent groups in people with Early Childhood Development, run by Boston University at 3 sites in Zambia.
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 10 inclusion and 6 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 16 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Zambia. 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?
Child linear growth: Stunting (time frame: Children aged 0-5 months at baseline (August-September 2019) and end line (September 2021), child aged 24-29 months). The study lists 3 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 NCT03991182, which also lists 3 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 16 Aug 2023.