Testing Means to Scale Early Childhood Development Interventions in Rural Kenya

NCT03548558 | Completed Results

• 3 other identifiers: 1R01HD090045R21HD098508R01HD090045
• Study Type: interventional
• Target: 1,152
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Early Child Development

Keywords

Early Childhood Development; Parenting Behaviors; Group-based curriculum; Kenya; Child Outcomes; Community Health Volunteers

Outcome Measures

Primary Outcomes (4)

• 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.

• 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

• 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).

• 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 Outcomes (2)

• Child Height

  Month 11/endline survey.

• Changes in Nutritional Practices

  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).

Other Outcomes (7)

• Changes in Perceived Social Support

  Baseline, 10-12, and 22-24 months after intervention

• Changes in Relationship Support Scale

  Baseline, 10-12, and 22-24 months after intervention

• Changes in Problem Solving/Social Support

  Baseline, 10-12, and 22-24 months after intervention

Study Arms (7)

Arm 1 ("group" sessions)

EXPERIMENTAL

Group meetings only (16 total)

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)

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

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

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.

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.

Behavioral: Group sessions; Behavioral: Group+Home sessions

Interventions

Group sessions BEHAVIORAL

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.

Arm 1 ("group" sessions); Arm A (Non-booster villages); Arm B (Booster villages); Arm X: Fathers invited; Arm Y: Fathers not invited

Group+Home sessions BEHAVIORAL

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.

Arm 2 ("group+home" sessions); Arm A (Non-booster villages); Arm B (Booster villages); Arm X: Fathers invited; Arm Y: Fathers not invited

Booster sessions BEHAVIORAL

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.

Arm B (Booster villages)

Fathers invited BEHAVIORAL

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.

Arm X: Fathers invited

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Southern California: lead
• Lunenfeld Tanenbaum Research Institute: collaborator
• Safe Water and AIDS Project: collaborator
• University of California, Berkeley: collaborator
• McGill University: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

USC

Los Angeles, California, 90089, United States

Location

Related Publications (4)

• 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.

  PMID: 34582449 DERIVED

• 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.

  PMID: 34026713 DERIVED

• 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.

  PMID: 33341153 DERIVED

• 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.

  PMID: 30832624 DERIVED

Results Point of Contact

• Title: Dr. Jill Luoto
• Organization: University of Southern California

jluoto@usc.edu

+1-213-764-1581

Study Officials

• Jill E. Luoto, PhD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The study will have separate teams for collection of surveys and program implementation. Due to the nature of the intervention, the participants and delivery agents will not be blinded to their study allocation as part of the program implementation team. Data collectors of surveys for the research team will, however, be blinded to the intervention allocation status of participants and villages. (Baseline surveys will be collected prior to randomization.) Likewise, data analysis will be blinded to the intervention status of participants and villages.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist

Model Details: 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.

Study Record Dates

• First Submitted: April 10, 2018
• First Posted: June 7, 2018
• Study Start: October 1, 2018
• Primary Completion: October 15, 2021
• Study Completion: October 15, 2021
• Last Updated: October 13, 2023
• Results First Posted: October 13, 2023

Record last verified: 2023-09

Locations

US (1)