Early Child DevelopmentNCT03548558

Testing Means to Scale Early Childhood Development Interventions in Rural Kenya

A study testing Group sessions, Group+Home sessions and Booster sessions in people with Early Child Development, run by University of Southern California at 1 site in United States.

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

Who is it for?: Ages 15 years and olderHealthy volunteers can take part
Conditions the study is for: Early Child Development
What is being tested?: Group sessions, Group+Home sessions and Booster sessions
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,152 participants
Where: 1 siteUnited States
Study dates: 1 Oct 2018to 15 Oct 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 15 years and older
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

Kenyan mothers or equivalent female primary caretakers aged 15 and over with children aged 6-24 months (classified as mature minors)
Kenyan fathers aged 18 and older with children aged 6-24 months with a mother present
The unit of observation for the study is the household or family, within which the primary focus is mother-child dyads and household eligibility hinges on the age of the child. For those households with a father present, the study will additionally include him in some analyses and surveys.

Who cannot join

Households without children
Households with children that are outside the age range of 6-24 months at baseline
Households with a mother younger than 15 or one aged 15-18 still living with her parents
Single fathers
Selection criteria for fathers are based on the mother-child eligibility criteria. Fathers will be included if and when appropriate per the details surrounding the mother-child dyads.

Trial locations and contacts

1 site in 1 country.

United States1 site

USC
Los Angeles, California, 90089

Other trials in United States

About this study

This study aims to experimentally test the effectiveness and cost-effectiveness of competing models of delivery of an Early Childhood Development (ECD) intervention in rural Kenya to determine how to maximize their reach to improve child cognitive, language and relevant psychosocial outcomes. The study will also include a longer-term evaluation of sustained impacts; an examination of the pathways of change leading to intervention impacts to inform policy; and examination of the role of paternal involvement on child development. Findings will provide policy makers with rigorous evidence of how best to expand ECD interventions in low-resource rural settings to improve child developmental outcomes for both the short-and longer-term.

Read the detailed description

Recent neurobiological and psychological research has established that vital development occurs in language, cognitive, motor and socio-emotional development during the first few years of life, and early life outcomes are key determinants of adult outcomes such as educational achievement, labor market outcomes, and health. Yet more than 200 million children under age five in low and middle income countries (LMICs) will fail to reach their developmental potential as adults, predominantly due to poverty, poor health and nutrition, and inadequate cognitive and psychosocial stimulation. Early childhood development (ECD) interventions that integrate nutrition and child stimulation activities have been proposed as a powerful policy tool for the remediation of early disadvantages in poor settings, and numerous field studies have shown they can be effective in improving children's developmental and health outcomes, at least in the short-term. Key questions remain on what models of delivery are the most effective and cost-effective that can be potentially scalable in LMICs, as well as how to sustain parental behavioral changes over time, which can lead to long-term improvements in child development and the possibility of positive spillovers to benefit younger siblings. Having a better understanding of the underlying behavioral pathways leading from intervention, to parental behavior changes, to child impacts, is also key to inform policy about the optimal design of interventions to maximize their scalability and sustainability. This study will conduct a multi-arm clustered randomized controlled trial across 60 villages and 1200 households in rural Western Kenya that tests different potentially cost-effective delivery models for an ECD intervention with a curriculum that integrates child psychosocial stimulation and nutrition education. Selected households will undergo baseline and follow-up surveys to measure short-term impacts in parental behaviors and children's developmental outcomes, and the study will collect data on potential mediators of parental behavioral change to uncover the pathways leading to impacts. Two follow-up surveys, one immediately after the end of the planned intervention and a second two years later, will enable testing of the short term and midterm sustainability of impacts, as well as the presence of any spillovers onto younger siblings. In collaboration with a local non-governmental organization (NGO), the Safe Water and AIDS Project (SWAP), community health volunteers (CHVs) will be trained to implement the intervention by introducing the ECD curriculum in their villages.

The goal of this study is to provide policymakers with rigorous evidence of how best to expand ECD interventions in low-resource rural settings.

Conditions: Early Child Development
Being tested: Group sessions, Group+Home sessions, Booster sessions, Fathers invited
Keywords: Early Childhood Development, Parenting Behaviors, Group-based curriculum, Kenya, Child Outcomes, Community Health Volunteers

What participants receive

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

Group sessionsBehavioural
Mother-child dyads in Arm 1 households will receive biweekly ECD sessions for a total of 16 sessions over 8 months. CHVs will record attendance at each session. To maximize participation, prior to each session the CHVs will send a short message service (SMS) mobile phone reminder of the session's topic, time and location to all participants.
Group+Home sessionsBehavioural
Households in Arm 2 will receive a total of 16 sessions with identical content similar to Arm 1, but 4 of those sessions will replace group sessions held at the level of villages for personalized home visits, in which the CHV will visit each participant household to deliver these sessions. These home visits will cover identical material and topics as the group sessions in Arm 1 villages, but will be delivered on a personalized basis in the home of the mother and child. Personal barriers to the practices will be discussed and an active resolution strategy developed in concert with the CHV.
Booster sessionsBehavioural
After the end of the 16 biweekly sessions (phase 1), we will re-randomize across the 40 intervention villages, stratified by Arms 1 and 2, and half of each of Arm 1 and Arm 2 villages will receive group booster visits every other month for the period between end-line and follow-up surveys. This will constitute Phase 2 of the study.
Fathers invitedBehavioural
During phase 1's 16 biweekly sessions, in half of Arm 1 and Arm 2 villages (20 total), fathers will additionally be invited to attend the 16 sessions. Separate father-only sessions will be held for 4 of the 16 sessions. This randomization will end after phase 1.

Study groups in NCT03548558
Study group	Role	What they receive
Arm 1 ("group" sessions)	Experimental	Group meetings only (16 total) Receives: Behavioral: Group sessions
Arm 2 ("group+home" sessions)	Experimental	Mixed group meetings with a limited number of individual home visits (12 group meetings + 4 home visits) Receives: Behavioral: Group+Home sessions
Arm 3	No intervention	This arm will serve as the control group to identify the effects of a parenting intervention and the most effective mode of delivery, as well as the sustained impacts from the intervention
Arm B (Booster villages)	Experimental	In one half of Arm 1 and Arm 2 villages above, after the end of the main intensive intervention, extended light-touch group booster sessions held every other month over two years between the two follow-up surveys will be held Receives: Behavioral: Group sessions; Behavioral: Group+Home sessions; Behavioral: Booster sessions
Arm A (Non-booster villages)	Other	In the other half of Arm 1 and Arm 2 villages, no boosters will be held during phase 2 Receives: Behavioral: Group sessions; Behavioral: Group+Home sessions
Arm X: Fathers invited	Experimental	During phase 1, fathers were invited to attend sessions in half of Arms 1 and 2 villages. Receives: Behavioral: Group sessions; Behavioral: Group+Home sessions; Behavioral: Fathers invited
Arm Y: Fathers not invited	Other	During phase 1, fathers were not invited in the other half of Arms 1 and 2 villages. Receives: Behavioral: Group sessions; Behavioral: Group+Home sessions

What is being measured

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

Child Developmental Outcomes
The Bayley Scales of Infant Development 3rd edition (Bayley's III), is validated in African settings and provides measures for all dimensions of child development up to 42 months of age. The official age-standardized cognitive, receptive language, and expressive language scales have 0-19 ranges with higher values denoting better scores. At month 11/endline survey, cognitive, receptive language, and expressive language scales were collected. At baseline, cognitive and receptive language were collected. Month 11 reported here. Baseline outcomes reported elsewhere.
Measured: Month 11/Endline after end of Phase 1's 16 biweekly sessions (Arm 1 with & without fathers, Arm 2 with and without fathers, and Arm 3). Arms A and B created after the Month 11/Endline survey.
Child Developmental Outcomes
Block-design subtest of the Wechsler Preschool and Primary Scale of Intelligence - 4th Edition (WPPSI-IV) to measure cognitive non-verbal reasoning. This subtest produces an age-standardized scaled score that can range from 1 to 19, with higher scores denoting better outcomes. For expressive and receptive language we used Dholuo and Kiswahili versions of the British Picture Vocabulary Scale - III (BPVS III), which includes 168 items for use with ages 3-17 years old. Knowledge of receptive vocabulary is measured by asking the respondent to point to one of four pictures that corresponds to a word (object, person, or action) spoken by the assessor; for expressive vocabulary the assessor pointed to a picture and the child named it. Pictures were adapted to the Kenyan context previously. Raw language scale ranges 0-25 with higher values denoting better outcomes.
Measured: Month 35-37/Follow-Up survey (Arms 3, A and B), two years after end of Phase 1's 16 biweekly sessions
Parenting Practices (HOME Observation for Measurement of the Environment - HOME)
At follow-up surveys, the study will collect the Home Observation for Measurement of the Environment (HOME)- Short Form (SF) inventory. The HOME-SF includes items grouped into two sub-scales: emotional support and cognitive stimulation. It has four parts: one for children under age three; a second for children between the ages of three and five; a third for children ages six through nine; and a fourth version for children ten and over. The total raw score for the HOME-SF is a simple summation of the recorded individual item scores and it varies by age group, as the number of individual items varies according to the age of the child. At the endline/month 11 survey the HOME scale scores ranged from 0-45, with higher scores denoting better outcomes.
Measured: Month 11/Endline survey (Arm 1 with and without fathers, Arm 2 with and without Fathers, Arm 3).
Parenting Practices (HOME Observation for Measurement of the Environment - HOME)
At follow-up surveys, the study will collect the Home Observation for Measurement of the Environment (HOME)- Short Form (SF) inventory. The HOME-SF includes items grouped into two sub-scales: emotional support and cognitive stimulation. It has four parts: one for children under age three; a second for children between the ages of three and five; a third for children ages six through nine; and a fourth version for children ten and over. The total raw score for the HOME-SF is a simple summation of the recorded individual item scores and it varies by age group, as the number of individual items varies according to the age of the child. At the month 35-37/follow-up survey the HOME score ranged 0-55 with higher scores denoting better outcomes.
Measured: Month 35-37 Follow-up Survey (Arms 3, A and B).

Secondary outcomes (2)

Child Height
child length-for-age measured in centimeters. Enumerators measured the child three times and calculated the mean; all measures were converted to length-for-age Z scores following World Health Organization (WHO) recommendations and calculated using Stata version 16's "zscore06" command that uses 2006 WHO child growth standards and adjusts for child age and sex. Mean score is 0 for reference population. A score of <-2 SD is considered stunted linear growth. Higher scores represent better outcomes.
Measured: Month 11/endline survey.
Changes in Nutritional Practices
Child dietary diversity is measured using a 0-7 scale in which parents report the categories of foods eaten by the child in the past 24 hours following WHO recommendations for child feeding. Higher scores denote better dietary diversity.
Measured: Month 11/endline survey (Arms 1, 2 with and without fathers, and Arm 3), and follow-up 2/month 35-37 survey (Arms 3, A and B).

Timeline

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

1 Oct 201815 Oct 2021

First posted7 Jun 2018
Study start1 Oct 2018
Primary completion15 Oct 2021
Study completion15 Oct 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Early Child DevelopmentStudies of the same condition, open and under way.
More trials run by University of Southern CaliforniaThe 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: Factorial
Model description: The evaluation design is conducted in two phases. During phase 1, a clustered Randomized Control Trial (cRCT) across 60 community health volunteers (CHVs) and their associated villages are randomly assigned to one of three equally-sized treatment arms: group meetings for 16 biweekly sessions over 8 months (Arm 1), 12 group meetings plus 4 home visits over 8 months (Arm 2), and a control group (Arm 3). Within half of villages assigned to Arms 1 and 2, fathers will also be invited to the sessions (a 2x2 factorial design among the 40 villages assigned to receive the intervention). After a first follow-up survey immediately after the end of the biweekly sessions, in phase 2 we stratify by Arms 1 and 2 and re-randomize villages so that 20 total receive booster group sessions every 2 months over another 2 years (10 each from Arms 1 and 2). The other 20 villages from Arms 1 and 2 do not receive extended boosters.
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 1,152 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03548558
Sponsor's protocol ID: 1R01HD090045
Other IDs: R21HD098508, R01HD090045
Status last verified: Sep 2023
First submitted: 10 Apr 2018
Last updated: 13 Oct 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Lopez Garcia I, Saya UY, Luoto JE. Cost-effectiveness and economic returns of group-based parenting interventions to promote early childhood development: Results from a randomized controlled trial in rural Kenya. PLoS Med. 2021 Sep 28;18(9):e1003746. doi: 10.1371/journal.pmed.1003746. eCollection 2021 Sep.
PubMed 34582449
Luoto JE, Lopez Garcia I, Aboud FE, Singla DR, Zhu R, Otieno R, Alu E. An Implementation Evaluation of A Group-Based Parenting Intervention to Promote Early Childhood Development in Rural Kenya. Front Public Health. 2021 May 5;9:653106. doi: 10.3389/fpubh.2021.653106. eCollection 2021.
PubMed 34026713
Luoto JE, Lopez Garcia I, Aboud FE, Singla DR, Fernald LCH, Pitchik HO, Saya UY, Otieno R, Alu E. Group-based parenting interventions to promote child development in rural Kenya: a multi-arm, cluster-randomised community effectiveness trial. Lancet Glob Health. 2021 Mar;9(3):e309-e319. doi: 10.1016/S2214-109X(20)30469-1. Epub 2020 Dec 17.
PubMed 33341153
Luoto JE, Lopez Garcia I, Aboud FE, Fernald LCH, Singla DR. Testing means to scale early childhood development interventions in rural Kenya: the Msingi Bora cluster randomized controlled trial study design and protocol. BMC Public Health. 2019 Mar 4;19(1):259. doi: 10.1186/s12889-019-6584-9.
PubMed 30832624

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 13 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Testing Means to Scale Early Childhood Development Interventions in Rural Kenya
ClinicalTrials.gov ID: NCT03548558
Acronym / sponsor ID: 1R01HD090045
Conditions: Early Child Development
Keywords: Early Childhood Development, Parenting Behaviors, Group-based curriculum, Kenya, Child Outcomes, Community Health Volunteers
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,152 participants (actual)
Lead sponsor: University of Southern CaliforniaUniversity, hospital or other
Collaborators: Lunenfeld Tanenbaum Research Institute, Safe Water and AIDS Project, University of California, Berkeley, McGill University, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study start: 1 Oct 2018 (actual)
Primary completion: 15 Oct 2021 (actual)
Study completion: 15 Oct 2021 (actual)
First posted: 7 Jun 2018 (actual)
Results: Posted 13 Oct 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The goal of this study is to provide policymakers with rigorous evidence of how best to expand ECD interventions in low-resource rural settings.

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Factorial
Masking: Single blind (outcomes assessor)
Number of arms: 7
Model description: The evaluation design is conducted in two phases. During phase 1, a clustered Randomized Control Trial (cRCT) across 60 community health volunteers (CHVs) and their associated villages are randomly assigned to one of three equally-sized treatment arms: group meetings for 16 biweekly sessions over 8 months (Arm 1), 12 group meetings plus 4 home visits over 8 months (Arm 2), and a control group (Arm 3). Within half of villages assigned to Arms 1 and 2, fathers will also be invited to the sessions (a 2x2 factorial design among the 40 villages assigned to receive the intervention). After a first follow-up survey immediately after the end of the biweekly sessions, in phase 2 we stratify by Arms 1 and 2 and re-randomize villages so that 20 total receive booster group sessions every 2 months over another 2 years (10 each from Arms 1 and 2). The other 20 villages from Arms 1 and 2 do not receive extended boosters.

Arm	Type	Receives
Arm 1 ("group" sessions)	Experimental	Behavioral: Group sessionsGroup meetings only (16 total)
Arm 2 ("group+home" sessions)	Experimental	Behavioral: Group+Home sessionsMixed group meetings with a limited number of individual home visits (12 group meetings + 4 home visits)
Arm 3	No intervention	–This arm will serve as the control group to identify the effects of a parenting intervention and the most effective mode of delivery, as well as the sustained impacts from the intervention
Arm B (Booster villages)	Experimental	Behavioral: Group sessions, Behavioral: Group+Home sessions, Behavioral: Booster sessionsIn one half of Arm 1 and Arm 2 villages above, after the end of the main intensive intervention, extended light-touch group booster sessions held every other month over two years between the two follow-up surveys will be held
Arm A (Non-booster villages)	Other	Behavioral: Group sessions, Behavioral: Group+Home sessionsIn the other half of Arm 1 and Arm 2 villages, no boosters will be held during phase 2
Arm X: Fathers invited	Experimental	Behavioral: Group sessions, Behavioral: Group+Home sessions, Behavioral: Fathers invitedDuring phase 1, fathers were invited to attend sessions in half of Arms 1 and 2 villages.
Arm Y: Fathers not invited	Other	Behavioral: Group sessions, Behavioral: Group+Home sessionsDuring phase 1, fathers were not invited in the other half of Arms 1 and 2 villages.

Who may qualify

Ages: 15 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (3 listed)

Kenyan mothers or equivalent female primary caretakers aged 15 and over with children aged 6-24 months (classified as mature minors)
Kenyan fathers aged 18 and older with children aged 6-24 months with a mother present
The unit of observation for the study is the household or family, within which the primary focus is mother-child dyads and household eligibility hinges on the age of the child. For those households with a father present, the study will additionally include him in some analyses and surveys.

Key exclusion criteria (5 listed)

Households without children
Households with children that are outside the age range of 6-24 months at baseline
Households with a mother younger than 15 or one aged 15-18 still living with her parents
Single fathers
Selection criteria for fathers are based on the mother-child eligibility criteria. Fathers will be included if and when appropriate per the details surrounding the mother-child dyads.

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
Group sessionsMother-child dyads in Arm 1 households will receive biweekly ECD sessions for a total of 16 sessions over 8 months. CHVs will record attendance at each session. To maximize participation, prior to each session the CHVs will send a short message service (SMS) mobile phone reminder of the session's topic, time and location to all participants.	Behavioural	Arm 1 ("group" sessions), Arm A (Non-booster villages), Arm B (Booster villages), Arm X: Fathers invited, Arm Y: Fathers not invited
Group+Home sessionsHouseholds in Arm 2 will receive a total of 16 sessions with identical content similar to Arm 1, but 4 of those sessions will replace group sessions held at the level of villages for personalized home visits, in which the CHV will visit each participant household to deliver these sessions. These home visits will cover identical material and topics as the group sessions in Arm 1 villages, but will be delivered on a personalized basis in the home of the mother and child. Personal barriers to the practices will be discussed and an active resolution strategy developed in concert with the CHV.	Behavioural	Arm 2 ("group+home" sessions), Arm A (Non-booster villages), Arm B (Booster villages), Arm X: Fathers invited, Arm Y: Fathers not invited
Booster sessionsAfter the end of the 16 biweekly sessions (phase 1), we will re-randomize across the 40 intervention villages, stratified by Arms 1 and 2, and half of each of Arm 1 and Arm 2 villages will receive group booster visits every other month for the period between end-line and follow-up surveys. This will constitute Phase 2 of the study.	Behavioural	Arm B (Booster villages)
Fathers invitedDuring phase 1's 16 biweekly sessions, in half of Arm 1 and Arm 2 villages (20 total), fathers will additionally be invited to attend the 16 sessions. Separate father-only sessions will be held for 4 of the 16 sessions. This randomization will end after phase 1.	Behavioural	Arm X: Fathers invited

Primary outcome

Child Developmental Outcomes
Time frame: Month 11/Endline after end of Phase 1's 16 biweekly sessions (Arm 1 with & without fathers, Arm 2 with and without fathers, and Arm 3). Arms A and B created after the Month 11/Endline survey.
The Bayley Scales of Infant Development 3rd edition (Bayley's III), is validated in African settings and provides measures for all dimensions of child development up to 42 months of age. The official age-standardized cognitive, receptive language, and expressive language scales have 0-19 ranges with higher values denoting better scores. At month 11/endline survey, cognitive, receptive language, and expressive language scales were collected. At baseline, cognitive and receptive language were collected. Month 11 reported here. Baseline outcomes reported elsewhere.
Child Developmental Outcomes
Time frame: Month 35-37/Follow-Up survey (Arms 3, A and B), two years after end of Phase 1's 16 biweekly sessions
Block-design subtest of the Wechsler Preschool and Primary Scale of Intelligence - 4th Edition (WPPSI-IV) to measure cognitive non-verbal reasoning. This subtest produces an age-standardized scaled score that can range from 1 to 19, with higher scores denoting better outcomes. For expressive and receptive language we used Dholuo and Kiswahili versions of the British Picture Vocabulary Scale - III (BPVS III), which includes 168 items for use with ages 3-17 years old. Knowledge of receptive vocabulary is measured by asking the respondent to point to one of four pictures that corresponds to a word (object, person, or action) spoken by the assessor; for expressive vocabulary the assessor pointed to a picture and the child named it. Pictures were adapted to the Kenyan context previously. Raw language scale ranges 0-25 with higher values denoting better outcomes.
Parenting Practices (HOME Observation for Measurement of the Environment - HOME)
Time frame: Month 11/Endline survey (Arm 1 with and without fathers, Arm 2 with and without Fathers, Arm 3).
At follow-up surveys, the study will collect the Home Observation for Measurement of the Environment (HOME)- Short Form (SF) inventory. The HOME-SF includes items grouped into two sub-scales: emotional support and cognitive stimulation. It has four parts: one for children under age three; a second for children between the ages of three and five; a third for children ages six through nine; and a fourth version for children ten and over. The total raw score for the HOME-SF is a simple summation of the recorded individual item scores and it varies by age group, as the number of individual items varies according to the age of the child. At the endline/month 11 survey the HOME scale scores ranged from 0-45, with higher scores denoting better outcomes.
Parenting Practices (HOME Observation for Measurement of the Environment - HOME)
Time frame: Month 35-37 Follow-up Survey (Arms 3, A and B).
At follow-up surveys, the study will collect the Home Observation for Measurement of the Environment (HOME)- Short Form (SF) inventory. The HOME-SF includes items grouped into two sub-scales: emotional support and cognitive stimulation. It has four parts: one for children under age three; a second for children between the ages of three and five; a third for children ages six through nine; and a fourth version for children ten and over. The total raw score for the HOME-SF is a simple summation of the recorded individual item scores and it varies by age group, as the number of individual items varies according to the age of the child. At the month 35-37/follow-up survey the HOME score ranged 0-55 with higher scores denoting better outcomes.

2 secondary outcomes

Child Height
Time frame: Month 11/endline survey.
Changes in Nutritional Practices
Time frame: Month 11/endline survey (Arms 1, 2 with and without fathers, and Arm 3), and follow-up 2/month 35-37 survey (Arms 3, A and B).

Results and safety

Results posted to the registry on 13 Oct 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Arm 1 "Groups" Without Fathers	173	161
Arm 1 "Groups" With Fathers	202	185
Arm 2 ("Group+Home" Sessions) Without Fathers	201	191
Arm 2 "Group + Home" Sessions, With Fathers Invited	199	182
Arm 3	377	351
Arm B (Booster Villages) (Phase 2)	0	0
Arm A (Non-booster Villages) Phase 2	0	0

Primary outcome: Child Developmental Outcomes

Time frame: Month 11/Endline after end of Phase 1's 16 biweekly sessions (Arm 1 with & without fathers, Arm 2 with and without fathers, and Arm 3). Arms A and B created after the Month 11/Endline survey.. Mean (Standard Deviation). Unit: age-standardized scores on a scale

Measure	Arm 1 "Groups" Without Fathers n = 161	Arm 1 "Groups" With Fathers n = 185	Arm 2 ("Group+Home" Sessions) Without Fathers n = 191	Arm 2 "Group + Home" Sessions, With Fathers Invited n = 182	Arm 3 n = 351	Arm B (Booster Villages) (Phase 2) n = 0	Arm A (Non-booster Villages) Phase 2 n = 0
Age-standardized cognitive score at month 11/endline survey	9.5 (1.8)	9.4 (1.7)	9.1 (1.5)	9.1 (1.6)	8.7 (1.5)	–	–
Age-standardized receptive language score at month 11/endline survey	10.6 (2.3)	10.5 (2.2)	10.0 (1.7)	10.2 (1.9)	9.7 (1.8)	–	–
Age-standardized expressive language score at month 11/endline survey	8.8 (138)	9.0 (1.6)	8.6 (1.7)	8.6 (1.5)	8.9 (1.7)	–	–

Population analysed: Arms A and B created after the Month 11/Endline survey after re-randomizing among Arms 1 and 2 (with and without fathers)

Primary outcome: Child Developmental Outcomes

Time frame: Month 35-37/Follow-Up survey (Arms 3, A and B), two years after end of Phase 1's 16 biweekly sessions. Mean (Standard Deviation). Unit: scores on a scale

Measure	Arm 1 "Groups" Without Fathers n = 0	Arm 1 "Groups" With Fathers n = 0	Arm 2 ("Group+Home" Sessions) Without Fathers n = 0	Arm 2 "Group + Home" Sessions, With Fathers Invited n = 0	Arm 3 n = 308	Arm B (Booster Villages) (Phase 2) n = 323	Arm A (Non-booster Villages) Phase 2 n = 313
Block Design WPPSI-III	–	–	–	–	4.9 (2.1)	5.2 (2.2)	5.1 (2.1)
BPVS receptive language	–	–	–	–	14.4 (4.2)	14.5 (4.2)	14.4 (4.3)
BPVS expressive language	–	–	–	–	10.5 (3.2)	10.4 (2.9)	10.6 (3.1)

Population analysed: Analyzed those children who were successfully tracked until this Month 35-37 survey

Primary outcome: Parenting Practices (HOME Observation for Measurement of the Environment - HOME)

Time frame: Month 11/Endline survey (Arm 1 with and without fathers, Arm 2 with and without Fathers, Arm 3).. Mean (Standard Deviation). Unit: score on a scale

Measure	Arm 1 "Groups" Without Fathers n = 161	Arm 1 "Groups" With Fathers n = 185	Arm 2 ("Group+Home" Sessions) Without Fathers n = 191	Arm 2 "Group + Home" Sessions, With Fathers Invited n = 182	Arm 3 n = 351	Arm B (Booster Villages) (Phase 2) n = 0	Arm A (Non-booster Villages) Phase 2 n = 0
Value	30.2 (5.6)	31.6 (5.9)	32.4 (5.2)	30.9 (6.1)	28.9 (6.2)	–	–

Population analysed: Sample sizes at month 11/endline survey. Arms A and B created after this survey.

Primary outcome: Parenting Practices (HOME Observation for Measurement of the Environment - HOME)

Time frame: Month 35-37 Follow-up Survey (Arms 3, A and B).. Mean (Standard Deviation). Unit: score on a scale

Measure	Arm 1 "Groups" Without Fathers n = 0	Arm 1 "Groups" With Fathers n = 0	Arm 2 ("Group+Home" Sessions) Without Fathers n = 0	Arm 2 "Group + Home" Sessions, With Fathers Invited n = 0	Arm 3 n = 308	Arm B (Booster Villages) (Phase 2) n = 323	Arm A (Non-booster Villages) Phase 2 n = 313
Value	–	–	–	–	36.7 (6.9)	38.5 (6.4)	37.6 (6.5)

Population analysed: Sample sizes at month 35-37/follow-up survey two years after end of Phase 1's 16 biweekly sessions.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected from Arms 1 and 2, with and without fathers, up to 13 months, then up to 2 years after re-randomization of Arms 1 and 2 into Arms A and B. Adverse Events were collected from Arm 3 throughout the entire study period, up to 37 months.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Arm 1 ("Group" Sessions) Without Fathers Invited	0 of 173 (0%)	0 of 173 (0%)	2 of 173
Arm 1 ("Group" Sessions) With Fathers Invited	0 of 202 (0%)	0 of 202 (0%)	1 of 202
Arm 2 ("Group+Home" Sessions) Without Fathers	0 of 201 (0%)	0 of 201 (0%)	0 of 201
Arm 2 ("Group + Home" Sessions) With Fathers Invited	0 of 199 (0%)	0 of 199 (0%)	1 of 199
Arm 3	0 of 377 (0%)	0 of 377 (0%)	3 of 377
Arm B (Booster Villages)	0 of 394 (0%)	0 of 394 (0%)	1 of 394
Arm A (Non-booster Villages)	0 of 378 (0%)	0 of 378 (0%)	1 of 378

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34582449Lopez Garcia I, Saya UY, Luoto JE. Cost-effectiveness and economic returns of group-based parenting interventions to promote early childhood development: Results from a randomized controlled trial in rural Kenya. PLoS Med. 2021 Sep 28;18(9):e1003746. doi: 10.1371/journal.pmed.1003746. eCollection 2021 Sep.
Derived from this study: PubMed 34026713Luoto JE, Lopez Garcia I, Aboud FE, Singla DR, Zhu R, Otieno R, Alu E. An Implementation Evaluation of A Group-Based Parenting Intervention to Promote Early Childhood Development in Rural Kenya. Front Public Health. 2021 May 5;9:653106. doi: 10.3389/fpubh.2021.653106. eCollection 2021.
Derived from this study: PubMed 33341153Luoto JE, Lopez Garcia I, Aboud FE, Singla DR, Fernald LCH, Pitchik HO, Saya UY, Otieno R, Alu E. Group-based parenting interventions to promote child development in rural Kenya: a multi-arm, cluster-randomised community effectiveness trial. Lancet Glob Health. 2021 Mar;9(3):e309-e319. doi: 10.1016/S2214-109X(20)30469-1. Epub 2020 Dec 17.
Derived from this study: PubMed 30832624Luoto JE, Lopez Garcia I, Aboud FE, Fernald LCH, Singla DR. Testing means to scale early childhood development interventions in rural Kenya: the Msingi Bora cluster randomized controlled trial study design and protocol. BMC Public Health. 2019 Mar 4;19(1):259. doi: 10.1186/s12889-019-6584-9.

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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.

Jill E. Luoto, PhD principal investigator

University of Southern California

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Group sessions, Group+Home sessions and Booster sessions in people with Early Child Development, run by University of Southern California at 1 site in United States.

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 5 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 13 Oct 2023. 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 United States. 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?

Yes. Results are posted in the registry (first posted 13 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Developmental Outcomes (time frame: Month 11/Endline after end of Phase 1's 16 biweekly sessions (Arm 1 with & without fathers, Arm 2 with and without fathers, and Arm 3). Arms A and B created after the Month 11/Endline survey.). The study lists 4 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 NCT03548558, which also lists 4 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 13 Oct 2023.