Trial Outcomes & Findings for Testing Means to Scale Early Childhood Development Interventions in Rural Kenya (NCT NCT03548558)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

1152 participants

Primary outcome timeframe

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.

Results posted on

2023-10-13

Participant Flow

1265 households assessed for eligibility during a household census exercise immediately preceding baseline survey (60 village clusters across 3 sub-counties)

Of 1265 assessed for eligibility, 1152 households were enrolled into the study and randomized to an intervention arm in phase 1. This included 1152 mothers, 1152 children, and 512 fathers at baseline. Analysis performed at level of households. Excluded households included 52 who migrated away, 20 refusals, 6 children had a physical or mental impairment and 35 households were unavailable after 3 visit attempts. Between phase 1 and 2, father arm washed out and replaced with booster randomization.

Unit of analysis: Cluster RCT at Village Level Assignment

Participant milestones

Participant milestones
Measure	Arm 1 "Groups" Without Fathers Group meetings only (16 total) for phase 1. Mother-child dyads in Arm 1 households will receive biweekly ECD sessions for a total of 16 sessions over 8 months for Phase 1. Fathers are not invited (10 total villages).	Arm 1 "Groups" With Fathers 10 total villages had group sessions and invited fathers during Phase 1's 16 biweekly sessions	Arm 2 ("Group+Home" Sessions) Without Fathers Mixed group meetings with a limited number of individual home visits (12 group meetings + 4 home visits) Group+Home sessions: During phase 1, 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. Fathers not invited. 10 villages total.	Arm 2 "Group + Home" Sessions, With Fathers Invited Mixed group meetings with a limited number of individual home visits (12 group meetings + 4 home visits) Group+Home sessions: During phase 1, 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. Fathers will also be invited. 10 villages total.	Arm 3 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) (Phase 2) 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 during phase 2. Group sessions: Mother-child dyads in Arm 1 households will receive biweekly ECD sessions for a total of 16 sessions over 7 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.	Arm A (Non-booster Villages) Phase 2 In the other half of Arm 1 and Arm 2 villages, no boosters will be held Group sessions: Mother-child dyads in Arm 1 households will receive biweekly ECD sessions for a total of 16 sessions over 7 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.
Phase 1: 16 Total Fortnightly Sessions STARTED	173 10	202 10	201 10	199 10	377 20	0 0	0 0
Phase 1: 16 Total Fortnightly Sessions COMPLETED	161 10	185 10	191 10	182 10	351 20	0 0	0 0
Phase 1: 16 Total Fortnightly Sessions NOT COMPLETED	12 0	17 0	10 0	17 0	26 0	0 0	0 0
Phase 2: Booster Sessions Every 2 Months STARTED	0 0	0 0	0 0	0 0	377 20	394 20	378 20
Phase 2: Booster Sessions Every 2 Months COMPLETED	0 0	0 0	0 0	0 0	308 20	323 20	313 20
Phase 2: Booster Sessions Every 2 Months NOT COMPLETED	0 0	0 0	0 0	0 0	69 0	71 0	65 0

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm 1 "Groups" Without Fathers Group meetings only (16 total) for phase 1. Mother-child dyads in Arm 1 households will receive biweekly ECD sessions for a total of 16 sessions over 8 months for Phase 1. Fathers are not invited (10 total villages).	Arm 1 "Groups" With Fathers 10 total villages had group sessions and invited fathers during Phase 1's 16 biweekly sessions	Arm 2 ("Group+Home" Sessions) Without Fathers Mixed group meetings with a limited number of individual home visits (12 group meetings + 4 home visits) Group+Home sessions: During phase 1, 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. Fathers not invited. 10 villages total.	Arm 2 "Group + Home" Sessions, With Fathers Invited Mixed group meetings with a limited number of individual home visits (12 group meetings + 4 home visits) Group+Home sessions: During phase 1, 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. Fathers will also be invited. 10 villages total.	Arm 3 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) (Phase 2) 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 during phase 2. Group sessions: Mother-child dyads in Arm 1 households will receive biweekly ECD sessions for a total of 16 sessions over 7 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.	Arm A (Non-booster Villages) Phase 2 In the other half of Arm 1 and Arm 2 villages, no boosters will be held Group sessions: Mother-child dyads in Arm 1 households will receive biweekly ECD sessions for a total of 16 sessions over 7 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.
Phase 1: 16 Total Fortnightly Sessions Death	2	1	0	1	0	0	0
Phase 1: 16 Total Fortnightly Sessions Withdrawal by Subject	3	1	1	3	2	0	0
Phase 1: 16 Total Fortnightly Sessions Lost to Follow-up	7	15	9	13	24	0	0
Phase 2: Booster Sessions Every 2 Months Death	0	0	0	0	3	1	1
Phase 2: Booster Sessions Every 2 Months Withdrawal by Subject	0	0	0	0	4	3	3
Phase 2: Booster Sessions Every 2 Months Lost to Follow-up	0	0	0	0	62	67	61

Baseline Characteristics

Recruitment and eligibility for study participation centered on mothers with eligible children. A total of 512 fathers were surveyed at baseline alongside mothers and children out of 1152 mother-child dyads originally recruited into the study. Numbers analyzed for fathers therefore lower.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm 1 ("Group" Sessions) Without Fathers n=173 Participants Group meetings only (16 total) Group sessions: Mother-child dyads in Arm 1 households will receive biweekly ECD sessions for a total of 16 sessions over 8 months. Fathers not invited.	Arm 1 ("Group" Sessions) With Fathers n=202 Participants Group meetings only (16 total) Group sessions: Mother-child dyads in Arm 1 households will receive biweekly ECD sessions for a total of 16 sessions over 8 months. Fathers will be invited.	Arm 2 ("Group+Home" Sessions) Without Fathers n=201 Participants Mixed group meetings with a limited number of individual home visits (12 group meetings + 4 home visits) 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. Fathers not invited.	Arm 2 ("Group+Home" Sessions) With Fathers n=199 Participants Mixed group meetings with a limited number of individual home visits (12 group meetings + 4 home visits) plus fathers invited. 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. Fathers invited.	Arm 3 n=377 Participants 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) 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 during phase 2.	Arm A (Non-booster Villages) In the other half of Arm 1 and Arm 2 villages, no boosters will be held during phase 2.	Total n=1152 Participants Total of all reporting groups
Age, Continuous	13.5 Months STANDARD_DEVIATION 5.2 • n=173 Participants	14.1 Months STANDARD_DEVIATION 4.8 • n=202 Participants	14.3 Months STANDARD_DEVIATION 4.7 • n=201 Participants	14.6 Months STANDARD_DEVIATION 4.7 • n=199 Participants	14.2 Months STANDARD_DEVIATION 4.7 • n=377 Participants	—	—	14.2 Months STANDARD_DEVIATION 4.8 • n=1152 Participants
Age, Customized Maternal age in years	28.7 years STANDARD_DEVIATION 9.0 • n=173 Participants	28.0 years STANDARD_DEVIATION 9.1 • n=202 Participants	28.7 years STANDARD_DEVIATION 8.9 • n=201 Participants	27.7 years STANDARD_DEVIATION 7.6 • n=199 Participants	29.2 years STANDARD_DEVIATION 9.0 • n=377 Participants	—	—	28.5 years STANDARD_DEVIATION 8.8 • n=1152 Participants
Sex: Female, Male Child Sex · Female	82 Participants n=173 Participants • Recruitment and eligibility for study participation centered on mothers with eligible children. A total of 512 fathers were surveyed at baseline alongside mothers and children out of 1152 mother-child dyads originally recruited into the study. Numbers analyzed for fathers therefore lower.	95 Participants n=202 Participants • Recruitment and eligibility for study participation centered on mothers with eligible children. A total of 512 fathers were surveyed at baseline alongside mothers and children out of 1152 mother-child dyads originally recruited into the study. Numbers analyzed for fathers therefore lower.	96 Participants n=201 Participants • Recruitment and eligibility for study participation centered on mothers with eligible children. A total of 512 fathers were surveyed at baseline alongside mothers and children out of 1152 mother-child dyads originally recruited into the study. Numbers analyzed for fathers therefore lower.	92 Participants n=199 Participants • Recruitment and eligibility for study participation centered on mothers with eligible children. A total of 512 fathers were surveyed at baseline alongside mothers and children out of 1152 mother-child dyads originally recruited into the study. Numbers analyzed for fathers therefore lower.	185 Participants n=377 Participants • Recruitment and eligibility for study participation centered on mothers with eligible children. A total of 512 fathers were surveyed at baseline alongside mothers and children out of 1152 mother-child dyads originally recruited into the study. Numbers analyzed for fathers therefore lower.	—	—	550 Participants n=1152 Participants • Recruitment and eligibility for study participation centered on mothers with eligible children. A total of 512 fathers were surveyed at baseline alongside mothers and children out of 1152 mother-child dyads originally recruited into the study. Numbers analyzed for fathers therefore lower.
Sex: Female, Male Child Sex · Male	91 Participants n=173 Participants • Recruitment and eligibility for study participation centered on mothers with eligible children. A total of 512 fathers were surveyed at baseline alongside mothers and children out of 1152 mother-child dyads originally recruited into the study. Numbers analyzed for fathers therefore lower.	107 Participants n=202 Participants • Recruitment and eligibility for study participation centered on mothers with eligible children. A total of 512 fathers were surveyed at baseline alongside mothers and children out of 1152 mother-child dyads originally recruited into the study. Numbers analyzed for fathers therefore lower.	105 Participants n=201 Participants • Recruitment and eligibility for study participation centered on mothers with eligible children. A total of 512 fathers were surveyed at baseline alongside mothers and children out of 1152 mother-child dyads originally recruited into the study. Numbers analyzed for fathers therefore lower.	107 Participants n=199 Participants • Recruitment and eligibility for study participation centered on mothers with eligible children. A total of 512 fathers were surveyed at baseline alongside mothers and children out of 1152 mother-child dyads originally recruited into the study. Numbers analyzed for fathers therefore lower.	192 Participants n=377 Participants • Recruitment and eligibility for study participation centered on mothers with eligible children. A total of 512 fathers were surveyed at baseline alongside mothers and children out of 1152 mother-child dyads originally recruited into the study. Numbers analyzed for fathers therefore lower.	—	—	602 Participants n=1152 Participants • Recruitment and eligibility for study participation centered on mothers with eligible children. A total of 512 fathers were surveyed at baseline alongside mothers and children out of 1152 mother-child dyads originally recruited into the study. Numbers analyzed for fathers therefore lower.
Sex: Female, Male Mother Sex · Female	173 Participants n=173 Participants • Recruitment and eligibility for study participation centered on mothers with eligible children. A total of 512 fathers were surveyed at baseline alongside mothers and children out of 1152 mother-child dyads originally recruited into the study. Numbers analyzed for fathers therefore lower.	202 Participants n=202 Participants • Recruitment and eligibility for study participation centered on mothers with eligible children. A total of 512 fathers were surveyed at baseline alongside mothers and children out of 1152 mother-child dyads originally recruited into the study. Numbers analyzed for fathers therefore lower.	201 Participants n=201 Participants • Recruitment and eligibility for study participation centered on mothers with eligible children. A total of 512 fathers were surveyed at baseline alongside mothers and children out of 1152 mother-child dyads originally recruited into the study. Numbers analyzed for fathers therefore lower.	199 Participants n=199 Participants • Recruitment and eligibility for study participation centered on mothers with eligible children. A total of 512 fathers were surveyed at baseline alongside mothers and children out of 1152 mother-child dyads originally recruited into the study. Numbers analyzed for fathers therefore lower.	377 Participants n=377 Participants • Recruitment and eligibility for study participation centered on mothers with eligible children. A total of 512 fathers were surveyed at baseline alongside mothers and children out of 1152 mother-child dyads originally recruited into the study. Numbers analyzed for fathers therefore lower.	—	—	1152 Participants n=1152 Participants • Recruitment and eligibility for study participation centered on mothers with eligible children. A total of 512 fathers were surveyed at baseline alongside mothers and children out of 1152 mother-child dyads originally recruited into the study. Numbers analyzed for fathers therefore lower.
Sex: Female, Male Mother Sex · Male	0 Participants n=173 Participants • Recruitment and eligibility for study participation centered on mothers with eligible children. A total of 512 fathers were surveyed at baseline alongside mothers and children out of 1152 mother-child dyads originally recruited into the study. Numbers analyzed for fathers therefore lower.	0 Participants n=202 Participants • Recruitment and eligibility for study participation centered on mothers with eligible children. A total of 512 fathers were surveyed at baseline alongside mothers and children out of 1152 mother-child dyads originally recruited into the study. Numbers analyzed for fathers therefore lower.	0 Participants n=201 Participants • Recruitment and eligibility for study participation centered on mothers with eligible children. A total of 512 fathers were surveyed at baseline alongside mothers and children out of 1152 mother-child dyads originally recruited into the study. Numbers analyzed for fathers therefore lower.	0 Participants n=199 Participants • Recruitment and eligibility for study participation centered on mothers with eligible children. A total of 512 fathers were surveyed at baseline alongside mothers and children out of 1152 mother-child dyads originally recruited into the study. Numbers analyzed for fathers therefore lower.	0 Participants n=377 Participants • Recruitment and eligibility for study participation centered on mothers with eligible children. A total of 512 fathers were surveyed at baseline alongside mothers and children out of 1152 mother-child dyads originally recruited into the study. Numbers analyzed for fathers therefore lower.	—	—	0 Participants n=1152 Participants • Recruitment and eligibility for study participation centered on mothers with eligible children. A total of 512 fathers were surveyed at baseline alongside mothers and children out of 1152 mother-child dyads originally recruited into the study. Numbers analyzed for fathers therefore lower.
Sex: Female, Male Father sex (baseline) · Female	0 Participants n=70 Participants • Recruitment and eligibility for study participation centered on mothers with eligible children. A total of 512 fathers were surveyed at baseline alongside mothers and children out of 1152 mother-child dyads originally recruited into the study. Numbers analyzed for fathers therefore lower.	0 Participants n=90 Participants • Recruitment and eligibility for study participation centered on mothers with eligible children. A total of 512 fathers were surveyed at baseline alongside mothers and children out of 1152 mother-child dyads originally recruited into the study. Numbers analyzed for fathers therefore lower.	0 Participants n=87 Participants • Recruitment and eligibility for study participation centered on mothers with eligible children. A total of 512 fathers were surveyed at baseline alongside mothers and children out of 1152 mother-child dyads originally recruited into the study. Numbers analyzed for fathers therefore lower.	0 Participants n=103 Participants • Recruitment and eligibility for study participation centered on mothers with eligible children. A total of 512 fathers were surveyed at baseline alongside mothers and children out of 1152 mother-child dyads originally recruited into the study. Numbers analyzed for fathers therefore lower.	0 Participants n=162 Participants • Recruitment and eligibility for study participation centered on mothers with eligible children. A total of 512 fathers were surveyed at baseline alongside mothers and children out of 1152 mother-child dyads originally recruited into the study. Numbers analyzed for fathers therefore lower.	—	—	0 Participants n=512 Participants • Recruitment and eligibility for study participation centered on mothers with eligible children. A total of 512 fathers were surveyed at baseline alongside mothers and children out of 1152 mother-child dyads originally recruited into the study. Numbers analyzed for fathers therefore lower.
Sex: Female, Male Father sex (baseline) · Male	70 Participants n=70 Participants • Recruitment and eligibility for study participation centered on mothers with eligible children. A total of 512 fathers were surveyed at baseline alongside mothers and children out of 1152 mother-child dyads originally recruited into the study. Numbers analyzed for fathers therefore lower.	90 Participants n=90 Participants • Recruitment and eligibility for study participation centered on mothers with eligible children. A total of 512 fathers were surveyed at baseline alongside mothers and children out of 1152 mother-child dyads originally recruited into the study. Numbers analyzed for fathers therefore lower.	87 Participants n=87 Participants • Recruitment and eligibility for study participation centered on mothers with eligible children. A total of 512 fathers were surveyed at baseline alongside mothers and children out of 1152 mother-child dyads originally recruited into the study. Numbers analyzed for fathers therefore lower.	103 Participants n=103 Participants • Recruitment and eligibility for study participation centered on mothers with eligible children. A total of 512 fathers were surveyed at baseline alongside mothers and children out of 1152 mother-child dyads originally recruited into the study. Numbers analyzed for fathers therefore lower.	162 Participants n=162 Participants • Recruitment and eligibility for study participation centered on mothers with eligible children. A total of 512 fathers were surveyed at baseline alongside mothers and children out of 1152 mother-child dyads originally recruited into the study. Numbers analyzed for fathers therefore lower.	—	—	512 Participants n=512 Participants • Recruitment and eligibility for study participation centered on mothers with eligible children. A total of 512 fathers were surveyed at baseline alongside mothers and children out of 1152 mother-child dyads originally recruited into the study. Numbers analyzed for fathers therefore lower.
Race/Ethnicity, Customized Black : Children	173 Participants n=173 Participants	202 Participants n=202 Participants	201 Participants n=201 Participants	199 Participants n=199 Participants	377 Participants n=377 Participants	—	—	1152 Participants n=1152 Participants
Race/Ethnicity, Customized Black : Mothers	173 Participants n=173 Participants	202 Participants n=202 Participants	201 Participants n=201 Participants	199 Participants n=199 Participants	377 Participants n=377 Participants	—	—	1152 Participants n=1152 Participants
Race/Ethnicity, Customized Black : Fathers	70 Participants n=173 Participants	90 Participants n=202 Participants	87 Participants n=201 Participants	103 Participants n=199 Participants	162 Participants n=377 Participants	—	—	512 Participants n=1152 Participants
Region of Enrollment Kenya	173 Households/enrolled children n=173 Participants	202 Households/enrolled children n=202 Participants	201 Households/enrolled children n=201 Participants	199 Households/enrolled children n=199 Participants	377 Households/enrolled children n=377 Participants	—	—	1152 Households/enrolled children n=1152 Participants
Child cognitive score (Bayley III) Baseline age-standardized cognitive scores	9.0 units on a scale (0-19) STANDARD_DEVIATION 2.3 • n=173 Participants	9.6 units on a scale (0-19) STANDARD_DEVIATION 2.1 • n=202 Participants	9.2 units on a scale (0-19) STANDARD_DEVIATION 2.2 • n=201 Participants	9.8 units on a scale (0-19) STANDARD_DEVIATION 2.3 • n=199 Participants	9.5 units on a scale (0-19) STANDARD_DEVIATION 2.3 • n=377 Participants	—	—	9.4 units on a scale (0-19) STANDARD_DEVIATION 2.2 • n=1152 Participants
Child cognitive score (Bayley III) Baseline age-standardized receptive language scores	9.2 units on a scale (0-19) STANDARD_DEVIATION 2.1 • n=173 Participants	9.4 units on a scale (0-19) STANDARD_DEVIATION 2.3 • n=202 Participants	9.2 units on a scale (0-19) STANDARD_DEVIATION 1.8 • n=201 Participants	10.0 units on a scale (0-19) STANDARD_DEVIATION 2.4 • n=199 Participants	9.7 units on a scale (0-19) STANDARD_DEVIATION 2.3 • n=377 Participants	—	—	9.5 units on a scale (0-19) STANDARD_DEVIATION 2.2 • n=1152 Participants
Family Care Indicators (FCI)	4.8 score on a scale STANDARD_DEVIATION 2.2 • n=173 Participants	4.7 score on a scale STANDARD_DEVIATION 2.0 • n=202 Participants	4.4 score on a scale STANDARD_DEVIATION 1.9 • n=201 Participants	4.8 score on a scale STANDARD_DEVIATION 2.0 • n=199 Participants	5.0 score on a scale STANDARD_DEVIATION 2.0 • n=377 Participants	—	—	4.8 score on a scale STANDARD_DEVIATION 2.0 • n=1152 Participants

PRIMARY outcome

Timeframe: 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.

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

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.

Outcome measures

Outcome measures
Measure	Arm 1 "Groups" Without Fathers n=161 Participants Group meetings only (16 total) for phase 1. Mother-child dyads in Arm 1 households will receive biweekly ECD sessions for a total of 16 sessions over 8 months for Phase 1. Fathers are not invited (10 total villages).	Arm 1 "Groups" With Fathers n=185 Participants 10 total villages had group sessions and invited fathers during Phase 1's 16 biweekly sessions	Arm 2 ("Group+Home" Sessions) Without Fathers n=191 Participants Mixed group meetings with a limited number of individual home visits (12 group meetings + 4 home visits) Group+Home sessions: During phase 1, 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. Fathers not invited. 10 villages total.	Arm 2 "Group + Home" Sessions, With Fathers Invited n=182 Participants Mixed group meetings with a limited number of individual home visits (12 group meetings + 4 home visits) Group+Home sessions: During phase 1, 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. Fathers will also be invited. 10 villages total.	Arm 3 n=351 Participants 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) (Phase 2) 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 during phase 2. Group sessions: Mother-child dyads in Arm 1 households will receive biweekly ECD sessions for a total of 16 sessions over 7 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.	Arm A (Non-booster Villages) Phase 2 In the other half of Arm 1 and Arm 2 villages, no boosters will be held Group sessions: Mother-child dyads in Arm 1 households will receive biweekly ECD sessions for a total of 16 sessions over 7 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.
Child Developmental Outcomes Age-standardized cognitive score at month 11/endline survey	9.5 age-standardized scores on a scale Standard Deviation 1.8	9.4 age-standardized scores on a scale Standard Deviation 1.7	9.1 age-standardized scores on a scale Standard Deviation 1.5	9.1 age-standardized scores on a scale Standard Deviation 1.6	8.7 age-standardized scores on a scale Standard Deviation 1.5	—	—
Child Developmental Outcomes Age-standardized receptive language score at month 11/endline survey	10.6 age-standardized scores on a scale Standard Deviation 2.3	10.5 age-standardized scores on a scale Standard Deviation 2.2	10.0 age-standardized scores on a scale Standard Deviation 1.7	10.2 age-standardized scores on a scale Standard Deviation 1.9	9.7 age-standardized scores on a scale Standard Deviation 1.8	—	—
Child Developmental Outcomes Age-standardized expressive language score at month 11/endline survey	8.8 age-standardized scores on a scale Standard Deviation 138	9.0 age-standardized scores on a scale Standard Deviation 1.6	8.6 age-standardized scores on a scale Standard Deviation 1.7	8.6 age-standardized scores on a scale Standard Deviation 1.5	8.9 age-standardized scores on a scale Standard Deviation 1.7	—	—

PRIMARY outcome

Timeframe: Month 35-37/Follow-Up survey (Arms 3, A and B), two years after end of Phase 1's 16 biweekly sessions

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

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.

Outcome measures

Outcome measures
Measure	Arm 1 "Groups" Without Fathers Group meetings only (16 total) for phase 1. Mother-child dyads in Arm 1 households will receive biweekly ECD sessions for a total of 16 sessions over 8 months for Phase 1. Fathers are not invited (10 total villages).	Arm 1 "Groups" With Fathers 10 total villages had group sessions and invited fathers during Phase 1's 16 biweekly sessions	Arm 2 ("Group+Home" Sessions) Without Fathers Mixed group meetings with a limited number of individual home visits (12 group meetings + 4 home visits) Group+Home sessions: During phase 1, 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. Fathers not invited. 10 villages total.	Arm 2 "Group + Home" Sessions, With Fathers Invited Mixed group meetings with a limited number of individual home visits (12 group meetings + 4 home visits) Group+Home sessions: During phase 1, 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. Fathers will also be invited. 10 villages total.	Arm 3 n=308 Participants 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) (Phase 2) n=323 Participants 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 during phase 2. Group sessions: Mother-child dyads in Arm 1 households will receive biweekly ECD sessions for a total of 16 sessions over 7 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.	Arm A (Non-booster Villages) Phase 2 n=313 Participants In the other half of Arm 1 and Arm 2 villages, no boosters will be held Group sessions: Mother-child dyads in Arm 1 households will receive biweekly ECD sessions for a total of 16 sessions over 7 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.
Child Developmental Outcomes Block Design WPPSI-III	—	—	—	—	4.9 scores on a scale Standard Deviation 2.1	5.2 scores on a scale Standard Deviation 2.2	5.1 scores on a scale Standard Deviation 2.1
Child Developmental Outcomes BPVS receptive language	—	—	—	—	14.4 scores on a scale Standard Deviation 4.2	14.5 scores on a scale Standard Deviation 4.2	14.4 scores on a scale Standard Deviation 4.3
Child Developmental Outcomes BPVS expressive language	—	—	—	—	10.5 scores on a scale Standard Deviation 3.2	10.4 scores on a scale Standard Deviation 2.9	10.6 scores on a scale Standard Deviation 3.1

PRIMARY outcome

Timeframe: Month 11/Endline survey (Arm 1 with and without fathers, Arm 2 with and without Fathers, Arm 3).

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

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.

Outcome measures

Outcome measures
Measure	Arm 1 "Groups" Without Fathers n=161 Participants Group meetings only (16 total) for phase 1. Mother-child dyads in Arm 1 households will receive biweekly ECD sessions for a total of 16 sessions over 8 months for Phase 1. Fathers are not invited (10 total villages).	Arm 1 "Groups" With Fathers n=185 Participants 10 total villages had group sessions and invited fathers during Phase 1's 16 biweekly sessions	Arm 2 ("Group+Home" Sessions) Without Fathers n=191 Participants Mixed group meetings with a limited number of individual home visits (12 group meetings + 4 home visits) Group+Home sessions: During phase 1, 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. Fathers not invited. 10 villages total.	Arm 2 "Group + Home" Sessions, With Fathers Invited n=182 Participants Mixed group meetings with a limited number of individual home visits (12 group meetings + 4 home visits) Group+Home sessions: During phase 1, 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. Fathers will also be invited. 10 villages total.	Arm 3 n=351 Participants 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) (Phase 2) 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 during phase 2. Group sessions: Mother-child dyads in Arm 1 households will receive biweekly ECD sessions for a total of 16 sessions over 7 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.	Arm A (Non-booster Villages) Phase 2 In the other half of Arm 1 and Arm 2 villages, no boosters will be held Group sessions: Mother-child dyads in Arm 1 households will receive biweekly ECD sessions for a total of 16 sessions over 7 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.
Parenting Practices (HOME Observation for Measurement of the Environment - HOME)	30.2 score on a scale Standard Deviation 5.6	31.6 score on a scale Standard Deviation 5.9	32.4 score on a scale Standard Deviation 5.2	30.9 score on a scale Standard Deviation 6.1	28.9 score on a scale Standard Deviation 6.2	—	—

PRIMARY outcome

Timeframe: Month 35-37 Follow-up Survey (Arms 3, A and B).

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

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.

Outcome measures

Outcome measures
Measure	Arm 1 "Groups" Without Fathers Group meetings only (16 total) for phase 1. Mother-child dyads in Arm 1 households will receive biweekly ECD sessions for a total of 16 sessions over 8 months for Phase 1. Fathers are not invited (10 total villages).	Arm 1 "Groups" With Fathers 10 total villages had group sessions and invited fathers during Phase 1's 16 biweekly sessions	Arm 2 ("Group+Home" Sessions) Without Fathers Mixed group meetings with a limited number of individual home visits (12 group meetings + 4 home visits) Group+Home sessions: During phase 1, 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. Fathers not invited. 10 villages total.	Arm 2 "Group + Home" Sessions, With Fathers Invited Mixed group meetings with a limited number of individual home visits (12 group meetings + 4 home visits) Group+Home sessions: During phase 1, 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. Fathers will also be invited. 10 villages total.	Arm 3 n=308 Participants 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) (Phase 2) n=323 Participants 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 during phase 2. Group sessions: Mother-child dyads in Arm 1 households will receive biweekly ECD sessions for a total of 16 sessions over 7 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.	Arm A (Non-booster Villages) Phase 2 n=313 Participants In the other half of Arm 1 and Arm 2 villages, no boosters will be held Group sessions: Mother-child dyads in Arm 1 households will receive biweekly ECD sessions for a total of 16 sessions over 7 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.
Parenting Practices (HOME Observation for Measurement of the Environment - HOME)	—	—	—	—	36.7 score on a scale Standard Deviation 6.9	38.5 score on a scale Standard Deviation 6.4	37.6 score on a scale Standard Deviation 6.5

SECONDARY outcome

Timeframe: Month 11/endline survey.

Population: At month 11/endline survey, child length-for-age was measured for a total of 1053 children out of 1070.

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.

Outcome measures

Outcome measures
Measure	Arm 1 "Groups" Without Fathers n=159 Participants Group meetings only (16 total) for phase 1. Mother-child dyads in Arm 1 households will receive biweekly ECD sessions for a total of 16 sessions over 8 months for Phase 1. Fathers are not invited (10 total villages).	Arm 1 "Groups" With Fathers n=182 Participants 10 total villages had group sessions and invited fathers during Phase 1's 16 biweekly sessions	Arm 2 ("Group+Home" Sessions) Without Fathers n=190 Participants Mixed group meetings with a limited number of individual home visits (12 group meetings + 4 home visits) Group+Home sessions: During phase 1, 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. Fathers not invited. 10 villages total.	Arm 2 "Group + Home" Sessions, With Fathers Invited n=180 Participants Mixed group meetings with a limited number of individual home visits (12 group meetings + 4 home visits) Group+Home sessions: During phase 1, 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. Fathers will also be invited. 10 villages total.	Arm 3 n=342 Participants 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) (Phase 2) 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 during phase 2. Group sessions: Mother-child dyads in Arm 1 households will receive biweekly ECD sessions for a total of 16 sessions over 7 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.	Arm A (Non-booster Villages) Phase 2 In the other half of Arm 1 and Arm 2 villages, no boosters will be held Group sessions: Mother-child dyads in Arm 1 households will receive biweekly ECD sessions for a total of 16 sessions over 7 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.
Child Height	-1.39 z-score length-for-age Standard Deviation 1.09	-1.42 z-score length-for-age Standard Deviation 1.00	-1.43 z-score length-for-age Standard Deviation 1.04	-1.46 z-score length-for-age Standard Deviation 1.14	-1.29 z-score length-for-age Standard Deviation 1.08	—	—

SECONDARY outcome

Timeframe: 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).

Population: Dietary diversity data collected for 1063 mother-child dyads at month 11/endline survey, and 942 dyads at two-year follow-up/month 35-37 survey. Arms A and B only analyzed at month 35-37 survey, Arms 1 \& 2 only at month 11/endline survey.

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.

Outcome measures

Outcome measures
Measure	Arm 1 "Groups" Without Fathers n=161 Participants Group meetings only (16 total) for phase 1. Mother-child dyads in Arm 1 households will receive biweekly ECD sessions for a total of 16 sessions over 8 months for Phase 1. Fathers are not invited (10 total villages).	Arm 1 "Groups" With Fathers n=184 Participants 10 total villages had group sessions and invited fathers during Phase 1's 16 biweekly sessions	Arm 2 ("Group+Home" Sessions) Without Fathers n=190 Participants Mixed group meetings with a limited number of individual home visits (12 group meetings + 4 home visits) Group+Home sessions: During phase 1, 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. Fathers not invited. 10 villages total.	Arm 2 "Group + Home" Sessions, With Fathers Invited n=181 Participants Mixed group meetings with a limited number of individual home visits (12 group meetings + 4 home visits) Group+Home sessions: During phase 1, 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. Fathers will also be invited. 10 villages total.	Arm 3 n=347 Participants 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) (Phase 2) n=323 Participants 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 during phase 2. Group sessions: Mother-child dyads in Arm 1 households will receive biweekly ECD sessions for a total of 16 sessions over 7 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.	Arm A (Non-booster Villages) Phase 2 n=313 Participants In the other half of Arm 1 and Arm 2 villages, no boosters will be held Group sessions: Mother-child dyads in Arm 1 households will receive biweekly ECD sessions for a total of 16 sessions over 7 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.
Changes in Nutritional Practices Dietary diversity at month 11/endline survey	4.3 scores on a scale Standard Deviation 1.1	4.3 scores on a scale Standard Deviation 1.2	4.1 scores on a scale Standard Deviation 1.1	4.0 scores on a scale Standard Deviation 1.1	4.1 scores on a scale Standard Deviation 1.2	—	—
Changes in Nutritional Practices Dietary diversity at follow-up 2/month 35-37 survey	—	—	—	—	3.8 scores on a scale Standard Deviation 1.1	3.7 scores on a scale Standard Deviation 1.3	3.7 scores on a scale Standard Deviation 1.3

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jill Luoto

University of Southern California

Phone: +1-213-764-1581

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place