Testing Means to Scale Early Childhood Development Interventions in Rural Kenya

Early Child Development Clinical Trial

Official title:

Testing Means to Scale Early Childhood Development Interventions in Rural Kenya

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03548558
• Other study ID #: 1R01HD090045
• Secondary ID: R21HD098508R01HD
• Status: Completed
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: October 15, 2021

Study information

• Verified date: September 2023
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1152
• Est. completion date: October 15, 2021
• Est. primary completion date: October 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Early Child Development

Intervention

Behavioral:
• Group sessions
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 sessions
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 sessions
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 invited
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.

Locations

Country	Name	City	State
United States	USC	Los Angeles	California

Sponsors (6)

Lead Sponsor	Collaborator
University of Southern California	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Lunenfeld Tanenbaum Research Institute, McGill University, Safe Water and AIDS Project (SWAP), University of California, Berkeley

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in Perceived Social Support	The study will measure perceived social support using the Duke-University of North Carolina (UNC) Functional Social Support Questionnaire, which is a multidimensional, self-administered instrument that assesses the social support that a person perceives that he or she has. The social support is measured as 2 scales for confidant or affective support.	Baseline, 10-12, and 22-24 months after intervention
Other	Changes in Relationship Support Scale	a 10-item measure self-reported by the mother on relationship quality with her husband using a 3-point scale from "rarely" to "most days" experiencing things ranging from the husband insulting the wife to the husband helping with child care.	Baseline, 10-12, and 22-24 months after intervention
Other	Changes in Problem Solving/Social Support	Daily stress will be assessed using the Daily Stress Index which measures on a 0-2 scale (never, sometimes, often) the difficult things that sometimes happen to people. This index has previously been used in Uganda, and the raw score will be aggregated over the 15 parts with a range of 0-30.	Baseline, 10-12, and 22-24 months after intervention
Other	Changes in Maternal Depression	The study will measure maternal psychological well-being using the widely used Center for Epidemiologic Studies Depression Scale (CESD) with proven psychometric properties. The 20-item scale examines how individuals have felt in the previous week. The options include: 0= Rarely (0-1 days); 1= Some or a little of the time (at least 1-2 days); 2= Most of the days (3 or more days). Scoring is done as follows: zero for answers in the first option, 1 for answers in the second option, 2 for answers in the third option. The scoring of positive items is reversed. Possible range of scores is zero to 60, with the higher scores indicating the presence of more symptomatology.	Baseline, 10-12, and 22-24 months after intervention
Other	Changes in Maternal Knowledge	The study will elicit maternal knowledge about child development through asking mothers about the ages at which they think the child would be able achieve certain developmental milestones, which are then compared with the expected ages reported in the literature.	Baseline, 10-12, and 22-24 months after intervention
Other	Changes in Maternal Beliefs	The study will adapt and measure the scale to elicit beliefs developed by Cunha et al. (2013)with the target of eliciting parental beliefs regarding the benefits of providing children better cognitive and non-cognitive stimulation. The instrument asks parents about developmental milestones in language and socio-emotional development under different home scenarios, which are constructed using data from the Family Care Indicators.	Baseline, 10-12, and 22-24 months after intervention
Other	Changes in Self-efficacy	The Self-Efficacy for Parenting Tasks Index-Toddler Scale (SEPTI-TS) is a 26-item questionnaire to assess parental self-efficacy in parents of toddlers. The Short Form of the SEPTI-TS showed a strong factor structure with four subscales of domain-specific parental self-efficacy (Nurturance, Discipline, Play, and Routine) that showed high reliability. Scores are rates from strongly disagree to strongly agree, and higher scores indicate stronger parental self-efficacy	Baseline, 10-12, and 22-24 months after intervention
Primary	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.	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.
Primary	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.	Month 35-37/Follow-Up survey (Arms 3, A and B), two years after end of Phase 1's 16 biweekly sessions
Primary	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.	Month 11/Endline survey (Arm 1 with and without fathers, Arm 2 with and without Fathers, Arm 3).
Primary	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.	Month 35-37 Follow-up Survey (Arms 3, A and B).
Secondary	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.	Month 11/endline survey.
Secondary	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.	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).