Child DevelopmentNCT06165315
Evaluation of a Group-based Parenting Intervention for Early Childhood Development
A study testing Parenting program in people with Child Development, run by Harvard School of Public Health (HSPH) at 1 site in Kenya.
Trial summary
This implementation research study aims to evaluate the impact and implementation of a group-based parenting program for improving early child development and caregiver outcomes. Read more about this study
- Who is it for?
- Ages 0 years and olderHealthy volunteers can take part
- Conditions the study is for
- Child Development
- What is being tested?
- Parenting program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 620 participants
- Where
- 1 siteKenya
- Study dates
- 1 Nov 2023to 30 Oct 2024
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- primary caregiver of a child aged 0-24 months at the time of enrollment
- the household resides within the geographic boundary of the village that was sampled into the research study
- primary caregiver provides informed consent for themselves and their child to participate
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
This implementation research study aims to evaluate the impact and implementation of a group-based parenting program for improving early child development and caregiver outcomes. This study is enrolling primary caregivers with children 0 to 24 months of age to promote caregiver knowledge and skills about nurturing care for young children and support caregiver psychosocial wellbeing. Parenting groups will leverage existing community group networks and be facilitated by trained volunteers for 20 total sessions (groups will meet twice a month for 10 months). ChildFund Kenya and its community partners will implement the program in Busia and Homabay counties. The research study design will involve a cluster-randomized controlled trial and a qualitative implementation evaluation. This research is being led by Emory University with funding from the Conrad N. Hilton Foundation.
Read the detailed description
This research has two study components and aims. First, a cluster-randomized controlled trial will be used to quantitatively estimate the effectiveness of the parenting program on early child development and caregiver outcomes. For the research study sample, villages in Busia and Homabay counties were randomly selected and randomly assigned in each county to either the intervention or waitlist control group. Villages in the intervention group will receive the parenting program first, while villages in the control group will receive the program after the completion of the research study. In total, 64 villages have been selected into this study. Then in each village, 10 primary caregivers with children 0-24 months of age will be enrolled into the study for a total of 640 caregiver-child dyads. A caregiver survey and observational assessment of early child development skills will be administered to study participants at baseline and endline to evaluate changes in outcomes between groups over time. Second, and following the completion of the program, qualitative in-depth interviews will be conducted with participants and various stakeholders (e.g., program participants, parenting group facilitators, community health volunteers, ChildFund program staff) to understand their roles and experiences with the parenting program as well as the challenges and successes to inform future implementation. This qualitative implementation evaluation will seek to identify the barriers and facilitators to program impact, quality delivery, scale-up, and sustainability.
- Conditions
- Child Development
- Being tested
- Parenting program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parenting programBehavioural
Villages in the intervention group will receive the parenting program. The parenting program consists of 20 total sessions, whereby groups will meet twice a month for 10 months.
| Study group | Role | What they receive |
|---|---|---|
| Parenting Program | Experimental | This community-based group parenting program aims improve caregiver knowledge, attitudes, and practices on nurturing care to ultimate improve early childhood development. A secondary aim of the program is to support caregiver psychosocial wellbeing. The curriculum covers various topics relating to responsive caregiving, early learning, child protection, maternal and child health and nutrition, and caregiver mental health. Intervention will be delivered through existing community group networks. Each parenting group will comprise of 10 caregivers that will be facilitated by trained volunteers. Receives: Behavioral: Parenting program |
| Waitlist-Control | No intervention | Villages in the control group will not immediately receive the parenting program. Instead, they will receive whatever standard of care services are delivered at the community-level (e.g., routine services from community health volunteers that are primarily focused on maternal and child health and nutrition). After endline data collection is completed for the trial, then villages in the control group will receive the parenting program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child development
Child development measured using the Global Scales of Early Development - Long Form (GSED-LF). GSED-LF is based on direct administration by a research assistant. GSED-LF provides one score for the overall development of children 0-36 months of age. GSED scores will be age-standardized to a mean of 0 and a standard deviation of 1. Higher scores will indicate improved early developmental skills.
Measured: 10 months
Secondary outcomes (8)
Child socioemotional development
Child socioemotional development based on observational rating by a research assistant using an adapted version of the Wolke Scales (e.g., child affect, vocalization, cooperation with the research assistant). An average score will be calculated across the items with higher scores indicating more positive child behaviors.
Measured: 10 months
Attitudes towards parenting
Primary caregivers will report the extent to which they agree with various statements about parental roles and engagement in nurturing care practices. A total score will be calculated with higher scores indicating more supportive parenting attitudes.
Measured: 10 months
Caregiving environment
Caregiving environment will be assessed using the Home Observation for Measurement of the Environment for infants and toddlers aged 0 to 3 years (HOME-IT). It combines caregiver-reported items and observations of parenting behaviors to assess early learning opportunities at home and responsive caregiving behaviors of primary caregiver with the child. A total score will be calculated with higher scores indicate more responsive caregiving and enriched home learning environments.
Measured: 10 months
Caregiver stimulation practices
Caregiver stimulation practices reported by primary caregiver about their engagement in early learning activities with the child (e.g. singing, telling stories). Activities adapted from the Family Care Indicators. A total score will be calculated with higher scores indicating more engagement in stimulation activities.
Measured: 10 months
Caregiver disciplinary practices
Caregiver disciplinary practices reported by primary caregivers in terms of harsh punishment (e.g., shook the child, shouted at child) and positive disciplinary practices (e.g., explained why the behavior was wrong) used towards the child. Items adapted from Child Discipline Module of Multiple Indicator Cluster Survey. Separate indicators will be created for use of any harsh disciplinary practices or any positive disciplinary practices.
Measured: 10 months
Infant and young child feeding practices
Infant and young child feeding (IYCF) practices including caregiver-reported breastfeeding and exclusive breastfeeding practices and child dietary diversity score (number of food groups the child consumed in previous 24 hours) based on WHO guidelines.
Measured: 10 months
Parenting stress
Parenting distress reported by the primary caregiver using the Parenting Stress Index-Short Form, Parental Distress subscale. Higher total scores indicate greater parenting distress.
Measured: 10 months
Depressive symptoms
Depressive symptoms reported by the primary caregiver using the Centre for Epidemiological Studies Depression Scale-10 items (CESD-10). Caregivers report on the frequency of depressive symptoms in the previous week. Items are summed to create an overall depression score, with higher scoring indicating greater depressive symptoms.
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2023
- Study start1 Nov 2023
- Primary completion30 Oct 2024 (estimated)
- Study completion30 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Child DevelopmentStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 620 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Harvard School of Public Health (HSPH)
- Sponsor type
- University, hospital or other
- Collaborators
- ChildFund Kenya, Conrad N. Hilton Foundation, B&M Consult
- Responsible party
- Principal investigator, Joshua Jeong, Harvard School of Public Health (HSPH)
- Investigators
- Joshua Jeong, ScD, Principal investigator, Harvard School of Public Health (HSPH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06165315
- Sponsor's protocol ID
- ISERC/JOOTRH/736/23
- Status last verified
- Jan 2024
- First submitted
- 2 Dec 2023
- Last updated
- 3 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kalam MA, McCann JK, Shakil Z, Gambari A, Ochieng M, Jeong J. Maternal Mental Health and Child Dietary Diversity in Rural Kenya: Findings From a Pooled Analysis of 2 Baseline Studies. Curr Dev Nutr. 2025 Jun 24;9(7):107497. doi: 10.1016/j.cdnut.2025.107497. eCollection 2025 Jul.
PubMed 40718429Jeong J, McCann JK, Onyango S, Ochieng M. A parenting program delivered through existing community-based peer groups to improve early child development in Homabay and Busia Counties, Kenya: study protocol for a cluster-randomized controlled trial. BMC Pediatr. 2024 Sep 17;24(1):592. doi: 10.1186/s12887-024-05065-7.
PubMed 39289646
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Group-based Parenting Intervention for Early Childhood Development
- ClinicalTrials.gov ID
- NCT06165315
- Acronym / sponsor ID
- ISERC/JOOTRH/736/23
- Conditions
- Child Development
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 620 participants (estimated)
- Lead sponsor
- Harvard School of Public Health (HSPH)University, hospital or other
- Collaborators
- ChildFund Kenya, Conrad N. Hilton Foundation, B&M Consult
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 30 Oct 2024 (estimated)
- Study completion
- 30 Oct 2024 (estimated)
- First posted
- 11 Dec 2023 (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.
This implementation research study aims to evaluate the impact and implementation of a group-based parenting program for improving early child development and caregiver outcomes. This study is enrolling primary caregivers with children 0 to 24 months of age to promote caregiver knowledge and skills about nurturing care for young children and support caregiver psychosocial wellbeing. Parenting groups will leverage existing community group networks and be facilitated by trained volunteers for 20 total sessions (groups will meet twice a month for 10 months). ChildFund Kenya and its community partners will implement the program in Busia and Homabay counties. The research study design will involve a cluster-randomized controlled trial and a qualitative implementation evaluation. This research is being led by Emory University with funding from the Conrad N. Hilton Foundation.
Detailed description
This research has two study components and aims. First, a cluster-randomized controlled trial will be used to quantitatively estimate the effectiveness of the parenting program on early child development and caregiver outcomes. For the research study sample, villages in Busia and Homabay counties were randomly selected and randomly assigned in each county to either the intervention or waitlist control group. Villages in the intervention group will receive the parenting program first, while villages in the control group will receive the program after the completion of the research study. In total, 64 villages have been selected into this study. Then in each village, 10 primary caregivers with children 0-24 months of age will be enrolled into the study for a total of 640 caregiver-child dyads. A caregiver survey and observational assessment of early child development skills will be administered to study participants at baseline and endline to evaluate changes in outcomes between groups over time. Second, and following the completion of the program, qualitative in-depth interviews will be conducted with participants and various stakeholders (e.g., program participants, parenting group facilitators, community health volunteers, ChildFund program staff) to understand their roles and experiences with the parenting program as well as the challenges and successes to inform future implementation. This qualitative implementation evaluation will seek to identify the barriers and facilitators to program impact, quality delivery, scale-up, and sustainability.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parenting Program | Experimental | Behavioral: Parenting programThis community-based group parenting program aims improve caregiver knowledge, attitudes, and practices on nurturing care to ultimate improve early childhood development. A secondary aim of the program is to support caregiver psychosocial wellbeing. The curriculum covers various topics relating to responsive caregiving, early learning, child protection, maternal and child health and nutrition, and caregiver mental health. Intervention will be delivered through existing community group networks. Each parenting group will comprise of 10 caregivers that will be facilitated by trained volunteers. |
| Waitlist-Control | No intervention | –Villages in the control group will not immediately receive the parenting program. Instead, they will receive whatever standard of care services are delivered at the community-level (e.g., routine services from community health volunteers that are primarily focused on maternal and child health and nutrition). After endline data collection is completed for the trial, then villages in the control group will receive the parenting program. |
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- primary caregiver of a child aged 0-24 months at the time of enrollment
- the household resides within the geographic boundary of the village that was sampled into the research study
- primary caregiver provides informed consent for themselves and their child to participate
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| Parenting programVillages in the intervention group will receive the parenting program. The parenting program consists of 20 total sessions, whereby groups will meet twice a month for 10 months. | Behavioural | Parenting Program |
Primary outcome
Child development
Time frame: 10 months
Child development measured using the Global Scales of Early Development - Long Form (GSED-LF). GSED-LF is based on direct administration by a research assistant. GSED-LF provides one score for the overall development of children 0-36 months of age. GSED scores will be age-standardized to a mean of 0 and a standard deviation of 1. Higher scores will indicate improved early developmental skills.
8 secondary outcomes
Child socioemotional development
Time frame: 10 months
Attitudes towards parenting
Time frame: 10 months
Caregiving environment
Time frame: 10 months
Caregiver stimulation practices
Time frame: 10 months
Caregiver disciplinary practices
Time frame: 10 months
Infant and young child feeding practices
Time frame: 10 months
Parenting stress
Time frame: 10 months
Depressive symptoms
Time frame: 10 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2024.
- Derived from this study: PubMed 40718429Kalam MA, McCann JK, Shakil Z, Gambari A, Ochieng M, Jeong J. Maternal Mental Health and Child Dietary Diversity in Rural Kenya: Findings From a Pooled Analysis of 2 Baseline Studies. Curr Dev Nutr. 2025 Jun 24;9(7):107497. doi: 10.1016/j.cdnut.2025.107497. eCollection 2025 Jul.
- Derived from this study: PubMed 39289646Jeong J, McCann JK, Onyango S, Ochieng M. A parenting program delivered through existing community-based peer groups to improve early child development in Homabay and Busia Counties, Kenya: study protocol for a cluster-randomized controlled trial. BMC Pediatr. 2024 Sep 17;24(1):592. doi: 10.1186/s12887-024-05065-7.
- 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.
Joshua Jeong, ScD principal investigator
Harvard School of Public Health (HSPH)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parenting program in people with Child Development, run by Harvard School of Public Health (HSPH) at 1 site in Kenya.
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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 3 Jan 2024. 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 Kenya. 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?
Results are not available in the source record.
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 development (time frame: 10 months). 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 NCT06165315, 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 3 Jan 2024; AzTrials last refreshed its copy on 6 Nov 2026.