Early Child Development
Conditions
Keywords
Early Childhood Development, Parenting Behaviors, Group-based curriculum, Kenya, Child Outcomes, Community Health Volunteers
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.
Detailed description
Recent neurobiological and psychological research has established that vital development occurs in language, cognitive, motor and socio-emotional development during the first few years of life, and early life outcomes are key determinants of adult outcomes such as educational achievement, labor market outcomes, and health. Yet more than 200 million children under age five in low and middle income countries (LMICs) will fail to reach their developmental potential as adults, predominantly due to poverty, poor health and nutrition, and inadequate cognitive and psychosocial stimulation. Early childhood development (ECD) interventions that integrate nutrition and child stimulation activities have been proposed as a powerful policy tool for the remediation of early disadvantages in poor settings, and numerous field studies have shown they can be effective in improving children's developmental and health outcomes, at least in the short-term. Key questions remain on what models of delivery are the most effective and cost-effective that can be potentially scalable in LMICs, as well as how to sustain parental behavioral changes over time, which can lead to long-term improvements in child development and the possibility of positive spillovers to benefit younger siblings. Having a better understanding of the underlying behavioral pathways leading from intervention, to parental behavior changes, to child impacts, is also key to inform policy about the optimal design of interventions to maximize their scalability and sustainability. This study will conduct a multi-arm clustered randomized controlled trial across 60 villages and 1200 households in rural Western Kenya that tests different potentially cost-effective delivery models for an ECD intervention with a curriculum that integrates child psychosocial stimulation and nutrition education. Selected households will undergo baseline and follow-up surveys to measure short-term impacts in parental behaviors and children's developmental outcomes, and the study will collect data on potential mediators of parental behavioral change to uncover the pathways leading to impacts. Two follow-up surveys, one immediately after the end of the planned intervention and a second two years later, will enable testing of the short term and midterm sustainability of impacts, as well as the presence of any spillovers onto younger siblings. In collaboration with a local non-governmental organization (NGO), the Safe Water and AIDS Project (SWAP), community health volunteers (CHVs) will be trained to implement the intervention by introducing the ECD curriculum in their villages. The goal of this study is to provide policymakers with rigorous evidence of how best to expand ECD interventions in low-resource rural settings.
Interventions
BEHAVIORALGroup 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.
BEHAVIORALGroup+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.
BEHAVIORALBooster 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.
BEHAVIORALFathers 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.
Sponsors
Lunenfeld Tanenbaum Research Institute
Safe Water and AIDS Project
University of California, Berkeley
McGill University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of Southern California
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Intervention model description
The evaluation design is conducted in two phases. During phase 1, a clustered Randomized Control Trial (cRCT) across 60 community health volunteers (CHVs) and their associated villages are randomly assigned to one of three equally-sized treatment arms: group meetings for 16 biweekly sessions over 8 months (Arm 1), 12 group meetings plus 4 home visits over 8 months (Arm 2), and a control group (Arm 3). Within half of villages assigned to Arms 1 and 2, fathers will also be invited to the sessions (a 2x2 factorial design among the 40 villages assigned to receive the intervention). After a first follow-up survey immediately after the end of the biweekly sessions, in phase 2 we stratify by Arms 1 and 2 and re-randomize villages so that 20 total receive booster group sessions every 2 months over another 2 years (10 each from Arms 1 and 2). The other 20 villages from Arms 1 and 2 do not receive extended boosters.
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Child Developmental Outcomes | Month 11/Endline after end of Phase 1's 16 biweekly sessions (Arm 1 with & without fathers, Arm 2 with and without fathers, and Arm 3). Arms A and B created after the Month 11/Endline survey. | The Bayley Scales of Infant Development 3rd edition (Bayley's III), is validated in African settings and provides measures for all dimensions of child development up to 42 months of age. The official age-standardized cognitive, receptive language, and expressive language scales have 0-19 ranges with higher values denoting better scores. At month 11/endline survey, cognitive, receptive language, and expressive language scales were collected. At baseline, cognitive and receptive language were collected. Month 11 reported here. Baseline outcomes reported elsewhere. |
| Parenting Practices (HOME Observation for Measurement of the Environment - HOME) | Month 11/Endline survey (Arm 1 with and without fathers, Arm 2 with and without Fathers, Arm 3). | At follow-up surveys, the study will collect the Home Observation for Measurement of the Environment (HOME)- Short Form (SF) inventory. The HOME-SF includes items grouped into two sub-scales: emotional support and cognitive stimulation. It has four parts: one for children under age three; a second for children between the ages of three and five; a third for children ages six through nine; and a fourth version for children ten and over. The total raw score for the HOME-SF is a simple summation of the recorded individual item scores and it varies by age group, as the number of individual items varies according to the age of the child. At the endline/month 11 survey the HOME scale scores ranged from 0-45, with higher scores denoting better outcomes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Child Height | Month 11/endline survey. | 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. |
| 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). | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Changes in Maternal Knowledge | Baseline, 10-12, and 22-24 months after intervention | 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. |
| Changes in Perceived Social Support | Baseline, 10-12, and 22-24 months after intervention | 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. |
| Changes in Self-efficacy | Baseline, 10-12, and 22-24 months after intervention | 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 |
| Changes in Maternal Beliefs | Baseline, 10-12, and 22-24 months after intervention | 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. |
| Changes in Relationship Support Scale | Baseline, 10-12, and 22-24 months after intervention | 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. |
| Changes in Problem Solving/Social Support | Baseline, 10-12, and 22-24 months after intervention | 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. |
| Changes in Maternal Depression | Baseline, 10-12, and 22-24 months after intervention | 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. |
Countries
United States
Participant flow
Recruitment details
1265 households assessed for eligibility during a household census exercise immediately preceding baseline survey (60 village clusters across 3 sub-counties)
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Arm 1 (Group Sessions) Without Fathers 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. | 173 |
| Arm 1 (Group Sessions) With Fathers 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. | 202 |
| 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: 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. | 201 |
| Arm 2 (Group+Home Sessions) With Fathers 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. | 199 |
| 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 | 377 |
| 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. | 0 |
| Arm A (Non-booster Villages) In the other half of Arm 1 and Arm 2 villages, no boosters will be held during phase 2. | 0 |
| Total | 1,152 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 |
|---|---|---|---|---|---|---|---|---|
| Phase 1: 16 Total Fortnightly Sessions | Death | 2 | 1 | 0 | 1 | 0 | 0 | 0 |
| Phase 1: 16 Total Fortnightly Sessions | Lost to Follow-up | 7 | 15 | 9 | 13 | 24 | 0 | 0 |
| Phase 1: 16 Total Fortnightly Sessions | Withdrawal by Subject | 3 | 1 | 1 | 3 | 2 | 0 | 0 |
| Phase 2: Booster Sessions Every 2 Months | Death | 0 | 0 | 0 | 0 | 3 | 1 | 1 |
| Phase 2: Booster Sessions Every 2 Months | Lost to Follow-up | 0 | 0 | 0 | 0 | 62 | 67 | 61 |
| Phase 2: Booster Sessions Every 2 Months | Withdrawal by Subject | 0 | 0 | 0 | 0 | 4 | 3 | 3 |
Baseline characteristics
| Characteristic | Arm 1 (Group Sessions) Without Fathers | Arm 1 (Group Sessions) With Fathers | Arm 2 (Group+Home Sessions) Without Fathers | Arm 2 (Group+Home Sessions) With Fathers | Arm 3 | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 13.5 Months STANDARD_DEVIATION 5.2 | 14.1 Months STANDARD_DEVIATION 4.8 | 14.3 Months STANDARD_DEVIATION 4.7 | 14.6 Months STANDARD_DEVIATION 4.7 | 14.2 Months STANDARD_DEVIATION 4.7 | 14.2 Months STANDARD_DEVIATION 4.8 |
| Age, Customized Maternal age in years | 28.7 years STANDARD_DEVIATION 9 | 28.0 years STANDARD_DEVIATION 9.1 | 28.7 years STANDARD_DEVIATION 8.9 | 27.7 years STANDARD_DEVIATION 7.6 | 29.2 years STANDARD_DEVIATION 9 | 28.5 years STANDARD_DEVIATION 8.8 |
| Child cognitive score (Bayley III) Baseline age-standardized cognitive scores | 9.0 units on a scale (0-19) STANDARD_DEVIATION 2.3 | 9.6 units on a scale (0-19) STANDARD_DEVIATION 2.1 | 9.2 units on a scale (0-19) STANDARD_DEVIATION 2.2 | 9.8 units on a scale (0-19) STANDARD_DEVIATION 2.3 | 9.5 units on a scale (0-19) STANDARD_DEVIATION 2.3 | 9.4 units on a scale (0-19) STANDARD_DEVIATION 2.2 |
| Child cognitive score (Bayley III) Baseline age-standardized receptive language scores | 9.2 units on a scale (0-19) STANDARD_DEVIATION 2.1 | 9.4 units on a scale (0-19) STANDARD_DEVIATION 2.3 | 9.2 units on a scale (0-19) STANDARD_DEVIATION 1.8 | 10.0 units on a scale (0-19) STANDARD_DEVIATION 2.4 | 9.7 units on a scale (0-19) STANDARD_DEVIATION 2.3 | 9.5 units on a scale (0-19) STANDARD_DEVIATION 2.2 |
| Family Care Indicators (FCI) | 4.8 score on a scale STANDARD_DEVIATION 2.2 | 4.7 score on a scale STANDARD_DEVIATION 2 | 4.4 score on a scale STANDARD_DEVIATION 1.9 | 4.8 score on a scale STANDARD_DEVIATION 2 | 5.0 score on a scale STANDARD_DEVIATION 2 | 4.8 score on a scale STANDARD_DEVIATION 2 |
| Race/Ethnicity, Customized Black : Children | 173 Participants | 202 Participants | 201 Participants | 199 Participants | 377 Participants | 1152 Participants |
| Race/Ethnicity, Customized Black : Fathers | 70 Participants | 90 Participants | 87 Participants | 103 Participants | 162 Participants | 512 Participants |
| Race/Ethnicity, Customized Black : Mothers | 173 Participants | 202 Participants | 201 Participants | 199 Participants | 377 Participants | 1152 Participants |
| Region of Enrollment Kenya | 173 Households/enrolled children | 202 Households/enrolled children | 201 Households/enrolled children | 199 Households/enrolled children | 377 Households/enrolled children | 1152 Households/enrolled children |
| Sex: Female, Male Child Sex Female | 82 Participants | 95 Participants | 96 Participants | 92 Participants | 185 Participants | 550 Participants |
| Sex: Female, Male Child Sex Male | 91 Participants | 107 Participants | 105 Participants | 107 Participants | 192 Participants | 602 Participants |
| Sex: Female, Male Father sex (baseline) Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Father sex (baseline) Male | 70 Participants | 90 Participants | 87 Participants | 103 Participants | 162 Participants | 512 Participants |
| Sex: Female, Male Mother Sex Female | 173 Participants | 202 Participants | 201 Participants | 199 Participants | 377 Participants | 1152 Participants |
| Sex: Female, Male Mother Sex Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 2 / 173 | 1 / 202 | 0 / 201 | 1 / 199 | 3 / 377 | 1 / 394 | 1 / 378 |
| other Total, other adverse events | 0 / 173 | 0 / 202 | 0 / 201 | 0 / 199 | 0 / 377 | 0 / 394 | 0 / 378 |
| serious Total, serious adverse events | 0 / 173 | 0 / 202 | 0 / 201 | 0 / 199 | 0 / 377 | 0 / 394 | 0 / 378 |
Outcome results
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.
Time frame: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 3 | Child Developmental Outcomes | BPVS receptive language | 14.4 scores on a scale | Standard Deviation 4.2 |
| Arm 3 | Child Developmental Outcomes | Block Design WPPSI-III | 4.9 scores on a scale | Standard Deviation 2.1 |
| Arm 3 | Child Developmental Outcomes | BPVS expressive language | 10.5 scores on a scale | Standard Deviation 3.2 |
| Arm B (Booster Villages) (Phase 2) | Child Developmental Outcomes | BPVS receptive language | 14.5 scores on a scale | Standard Deviation 4.2 |
| Arm B (Booster Villages) (Phase 2) | Child Developmental Outcomes | Block Design WPPSI-III | 5.2 scores on a scale | Standard Deviation 2.2 |
| Arm B (Booster Villages) (Phase 2) | Child Developmental Outcomes | BPVS expressive language | 10.4 scores on a scale | Standard Deviation 2.9 |
| Arm A (Non-booster Villages) Phase 2 | Child Developmental Outcomes | Block Design WPPSI-III | 5.1 scores on a scale | Standard Deviation 2.1 |
| Arm A (Non-booster Villages) Phase 2 | Child Developmental Outcomes | BPVS expressive language | 10.6 scores on a scale | Standard Deviation 3.1 |
| Arm A (Non-booster Villages) Phase 2 | Child Developmental Outcomes | BPVS receptive language | 14.4 scores on a scale | Standard Deviation 4.3 |
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.
Time frame: Month 11/Endline after end of Phase 1's 16 biweekly sessions (Arm 1 with & without fathers, Arm 2 with and without fathers, and Arm 3). Arms A and B created after the Month 11/Endline survey.
Population: Arms A and B created after the Month 11/Endline survey after re-randomizing among Arms 1 and 2 (with and without fathers)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1 Groups Without Fathers | Child Developmental Outcomes | Age-standardized cognitive score at month 11/endline survey | 9.5 age-standardized scores on a scale | Standard Deviation 1.8 |
| Arm 1 Groups Without Fathers | Child Developmental Outcomes | Age-standardized expressive language score at month 11/endline survey | 8.8 age-standardized scores on a scale | Standard Deviation 138 |
| Arm 1 Groups Without Fathers | 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 |
| Arm 1 Groups With Fathers | Child Developmental Outcomes | Age-standardized receptive language score at month 11/endline survey | 10.5 age-standardized scores on a scale | Standard Deviation 2.2 |
| Arm 1 Groups With Fathers | Child Developmental Outcomes | Age-standardized cognitive score at month 11/endline survey | 9.4 age-standardized scores on a scale | Standard Deviation 1.7 |
| Arm 1 Groups With Fathers | Child Developmental Outcomes | Age-standardized expressive language score at month 11/endline survey | 9.0 age-standardized scores on a scale | Standard Deviation 1.6 |
| Arm 2 (Group+Home Sessions) Without Fathers | Child Developmental Outcomes | Age-standardized receptive language score at month 11/endline survey | 10.0 age-standardized scores on a scale | Standard Deviation 1.7 |
| Arm 2 (Group+Home Sessions) Without Fathers | Child Developmental Outcomes | Age-standardized cognitive score at month 11/endline survey | 9.1 age-standardized scores on a scale | Standard Deviation 1.5 |
| Arm 2 (Group+Home Sessions) Without Fathers | Child Developmental Outcomes | Age-standardized expressive language score at month 11/endline survey | 8.6 age-standardized scores on a scale | Standard Deviation 1.7 |
| Arm 2 Group + Home Sessions, With Fathers Invited | Child Developmental Outcomes | Age-standardized cognitive score at month 11/endline survey | 9.1 age-standardized scores on a scale | Standard Deviation 1.6 |
| Arm 2 Group + Home Sessions, With Fathers Invited | Child Developmental Outcomes | Age-standardized expressive language score at month 11/endline survey | 8.6 age-standardized scores on a scale | Standard Deviation 1.5 |
| Arm 2 Group + Home Sessions, With Fathers Invited | Child Developmental Outcomes | Age-standardized receptive language score at month 11/endline survey | 10.2 age-standardized scores on a scale | Standard Deviation 1.9 |
| Arm 3 | Child Developmental Outcomes | Age-standardized receptive language score at month 11/endline survey | 9.7 age-standardized scores on a scale | Standard Deviation 1.8 |
| Arm 3 | Child Developmental Outcomes | Age-standardized cognitive score at month 11/endline survey | 8.7 age-standardized scores on a scale | Standard Deviation 1.5 |
| Arm 3 | Child Developmental Outcomes | Age-standardized expressive language score at month 11/endline survey | 8.9 age-standardized scores on a scale | Standard Deviation 1.7 |
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 3 | Parenting Practices (HOME Observation for Measurement of the Environment - HOME) | 36.7 score on a scale | Standard Deviation 6.9 |
| Arm B (Booster Villages) (Phase 2) | Parenting Practices (HOME Observation for Measurement of the Environment - HOME) | 38.5 score on a scale | Standard Deviation 6.4 |
| Arm A (Non-booster Villages) Phase 2 | Parenting Practices (HOME Observation for Measurement of the Environment - HOME) | 37.6 score on a scale | Standard Deviation 6.5 |
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 Groups Without Fathers | Parenting Practices (HOME Observation for Measurement of the Environment - HOME) | 30.2 score on a scale | Standard Deviation 5.6 |
| Arm 1 Groups With Fathers | Parenting Practices (HOME Observation for Measurement of the Environment - HOME) | 31.6 score on a scale | Standard Deviation 5.9 |
| Arm 2 (Group+Home Sessions) Without Fathers | Parenting Practices (HOME Observation for Measurement of the Environment - HOME) | 32.4 score on a scale | Standard Deviation 5.2 |
| Arm 2 Group + Home Sessions, With Fathers Invited | Parenting Practices (HOME Observation for Measurement of the Environment - HOME) | 30.9 score on a scale | Standard Deviation 6.1 |
| Arm 3 | Parenting Practices (HOME Observation for Measurement of the Environment - HOME) | 28.9 score on a scale | Standard Deviation 6.2 |
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.
Time frame: Month 11/endline survey (Arms 1, 2 with and without fathers, and Arm 3), and follow-up 2/month 35-37 survey (Arms 3, A and B).
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1 Groups Without Fathers | Changes in Nutritional Practices | Dietary diversity at month 11/endline survey | 4.3 scores on a scale | Standard Deviation 1.1 |
| Arm 1 Groups With Fathers | Changes in Nutritional Practices | Dietary diversity at month 11/endline survey | 4.3 scores on a scale | Standard Deviation 1.2 |
| Arm 2 (Group+Home Sessions) Without Fathers | Changes in Nutritional Practices | Dietary diversity at month 11/endline survey | 4.1 scores on a scale | Standard Deviation 1.1 |
| Arm 2 Group + Home Sessions, With Fathers Invited | Changes in Nutritional Practices | Dietary diversity at month 11/endline survey | 4.0 scores on a scale | Standard Deviation 1.1 |
| Arm 3 | Changes in Nutritional Practices | Dietary diversity at month 11/endline survey | 4.1 scores on a scale | Standard Deviation 1.2 |
| Arm 3 | Changes in Nutritional Practices | Dietary diversity at follow-up 2/month 35-37 survey | 3.8 scores on a scale | Standard Deviation 1.1 |
| Arm B (Booster Villages) (Phase 2) | Changes in Nutritional Practices | Dietary diversity at follow-up 2/month 35-37 survey | 3.7 scores on a scale | Standard Deviation 1.3 |
| Arm A (Non-booster Villages) Phase 2 | Changes in Nutritional Practices | Dietary diversity at follow-up 2/month 35-37 survey | 3.7 scores on a scale | Standard Deviation 1.3 |
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 Groups Without Fathers | Child Height | -1.39 z-score length-for-age | Standard Deviation 1.09 |
| Arm 1 Groups With Fathers | Child Height | -1.42 z-score length-for-age | Standard Deviation 1 |
| Arm 2 (Group+Home Sessions) Without Fathers | Child Height | -1.43 z-score length-for-age | Standard Deviation 1.04 |
| Arm 2 Group + Home Sessions, With Fathers Invited | Child Height | -1.46 z-score length-for-age | Standard Deviation 1.14 |
| Arm 3 | Child Height | -1.29 z-score length-for-age | Standard Deviation 1.08 |
Other Pre-specified
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.
Time frame: Baseline, 10-12, and 22-24 months after intervention
Other Pre-specified
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.
Time frame: Baseline, 10-12, and 22-24 months after intervention
Other Pre-specified
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.
Time frame: Baseline, 10-12, and 22-24 months after intervention
Other Pre-specified
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.
Time frame: Baseline, 10-12, and 22-24 months after intervention
Other Pre-specified
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.
Time frame: Baseline, 10-12, and 22-24 months after intervention
Other Pre-specified
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.
Time frame: Baseline, 10-12, and 22-24 months after intervention
Other Pre-specified
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
Time frame: Baseline, 10-12, and 22-24 months after intervention