Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Testing Means to Scale Early Childhood Development Interventions in Rural Kenya

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03548558
Recruitment Status : Recruiting
First Posted : June 7, 2018
Last Update Posted : February 1, 2019
Sponsor:
Collaborators:
Lunenfeld Tanenbaum Research Institute
Safe Water and AIDS Project (SWAP)
University of California, Berkeley
McGill University
Information provided by (Responsible Party):
RAND

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.

Condition or disease Intervention/treatment Phase
Early Child Development Behavioral: Group sessions Behavioral: Group+Home sessions Not Applicable

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 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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3802 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: The evaluation design consists of a clustered Randomized Control Trial (cRCT) in which 60 CHVs and their associated villages will be randomly assigned to one of three equally-sized treatment arms: group meetings only (Arm 1), group meetings with a limited number of individual home visits and booster sessions (Arm 2), and a control group (Arm 3). Within half of the villages assigned to Arms 1 and 2 (the intervention arms), fathers will also be invited to the group sessions (a 2x2 factorial design among the 40 villages assigned to receive the intervention). All households, including the control group (Arm 3), will receive basic information about child feeding during a baseline survey.
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.
Primary Purpose: Health Services Research
Official Title: Testing Means to Scale Early Childhood Development Interventions in Rural Kenya
Actual Study Start Date : November 1, 2018
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm 1 ("group" sessions)
Group meetings only
Behavioral: 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 an SMS reminder of the session's topic, time and location to all participants.

Experimental: Arm 2 ("group+home" sessions)
Group meetings with a limited number of individual home visits and booster sessions
Behavioral: 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. Households in Arm 2 will also receive two additional booster visits 3 and 6 months after the end of the ECD sessions.

No Intervention: 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
Experimental: Arm B (Father villages)
In one half of Arm 1 and Arm 2 villages above, fathers will be invited to attend the ECD sessions along with mothers.
Behavioral: 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 an SMS reminder of the session's topic, time and location to all participants.

Behavioral: 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. Households in Arm 2 will also receive two additional booster visits 3 and 6 months after the end of the ECD sessions.

Arm A (Mother-only villages)
In the other half of Arm 1 and Arm 2 villages, only mothers will be invited.
Behavioral: 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 an SMS reminder of the session's topic, time and location to all participants.

Behavioral: 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. Households in Arm 2 will also receive two additional booster visits 3 and 6 months after the end of the ECD sessions.




Primary Outcome Measures :
  1. Child developmental outcomes [ Time Frame: Baseline ]
    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.

  2. Child developmental outcomes [ Time Frame: 10-12 months after baseline ]
    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.

  3. Child developmental outcomes [ Time Frame: 22-24 months after baseline ]
    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.

  4. Child developmental outcomes [ Time Frame: Baseline for all children ]
    At baseline the study will collect the Malawi Developmental Assessment Tool (MDAT), which can be applied to children up to 6 years old and is culturally relevant in Sub Saharan African (SSA) settings, with good reliability.

  5. Child developmental outcomes [ Time Frame: 22-24 months after intervention for children above 42 months ]
    At the final follow-up survey roughly two years after the intervention for those children who have aged out of the Bayley's, the study will collect the Malawi Developmental Assessment Tool (MDAT), which can be applied to children up to 6 years old and is culturally relevant in Sub Saharan African (SSA) settings, with good reliability.

  6. Parenting behaviors [ Time Frame: Baseline ]

    At baseline, the study will use the Family Care Indicators, a self-reported measure of parenting practices which measures the quality time spent with children in learning and playing activities for young children at home.

    The items are grouped into the following theoretical subgroups: 'Varieties of play materials' (including picture books for young children) (7 items), which classified toys by their use; 'Sources of play materials' (4 items), which identified where the play materials came from; and 'Play activities' (6 items), which identified specific types of activities done by any adult in the home with the child in the previous three days. All these items were scored: yes=1 and no=0 (presence or absence of play material or activity). Higher values are considered to better.


  7. Parenting behaviors [ Time Frame: 10-12 months after baseline ]
    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. At several survey points, as mentioned, the set of questions in the HOME sections of the survey was expanded, but these added items are not part of the total HOME score or subscores. Response options for the interview portion are in multiple-choice format, but are converted to binary variables for scoring. 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.

  8. Parenting behaviors [ Time Frame: 22-24 months after baseline ]
    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. At several survey points, as mentioned, the set of questions in the HOME sections of the survey was expanded, but these added items are not part of the total HOME score or subscores. Response options for the interview portion are in multiple-choice format, but are converted to binary variables for scoring. 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.


Secondary Outcome Measures :
  1. Child weight [ Time Frame: Baseline, plus 10-12, and 22-24 months after baseline ]
    weight in kilograms

  2. Child height [ Time Frame: Baseline, plus 10-12, and 22-24 months after baseline ]
    height in meters, which will be combined with weight to report BMI in kg/m^2.

  3. Changes in nutritional practices [ Time Frame: baseline, 10-12, and 22-24 months after intervention ]
    Food security will be measured using the Household Food Insecurity Access Scale (HFIAS). This scale measures food insecurity. The questionnaire consists of nine questions that represent a generally increasing level of severity of food insecurity (access). Each HFIAS question consists of the stem (timeframe for recall), the body of the question (refers to a specific behavior or attitude), and four response options (0 to 3) that represent a range of frequencies (0 = never, 1 = rarely, 2 = sometimes, 3 = often). The HFIAS score is a continuous measure of the degree of food insecurity (access) in the household (in the past 30 days). The maximum score for a household is 27 (the household response to all 9 questions was "often", coded with response code of 3); the minimum score is 0. The higher the score, the more food insecurity (access) the household experienced. The lower the score, the less food insecurity (access) a household experienced.


Other Outcome Measures:
  1. Changes in perceived social support [ Time Frame: Baseline, 10-12, and 22-24 months after intervention ]
    The study will measure perceived social support using the Duke-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.

  2. Changes in relationship support scale [ Time Frame: 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.

  3. Changes in Problem solving/social support [ Time Frame: 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.

  4. Changes in maternal depression [ Time Frame: 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.

  5. Changes in Maternal Knowledge [ Time Frame: 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.

  6. Changes in Maternal Beliefs [ Time Frame: 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.

  7. Changes in self-efficacy [ Time Frame: Baseline, 10-12, and 22-24 months after intervention ]
    The Self-Efficacy for Parenting Tasks Index-Toddler Scale or 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03548558


Contacts
Layout table for location contacts
Contact: Jill E. Luoto, PhD +1.310.393.0411 ext 6337 jluoto@rand.org
Contact: Italo Lopez Garcia, PhD +1.310.393.0411 ext 6649 ilopezga@rand.org

Locations
Layout table for location information
United States, California
RAND Recruiting
Santa Monica, California, United States, 90407
Contact: Jill E. Luoto, PhD    310-393-0411 ext 6337      
Principal Investigator: Jill E. Luoto, PhD         
Sponsors and Collaborators
RAND
Lunenfeld Tanenbaum Research Institute
Safe Water and AIDS Project (SWAP)
University of California, Berkeley
McGill University
Investigators
Layout table for investigator information
Principal Investigator: Jill E. Luoto, PhD RAND

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: RAND
ClinicalTrials.gov Identifier: NCT03548558     History of Changes
Other Study ID Numbers: 1R01HD090045 ( U.S. NIH Grant/Contract )
First Posted: June 7, 2018    Key Record Dates
Last Update Posted: February 1, 2019
Last Verified: January 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by RAND:
Early Childhood Development
Parenting Behaviors
Group-based curriculum
Kenya
Child Outcomes
Community Health Volunteers