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Child DevelopmentFSI-ECDNCT03455127

Alliance for Family Strengthening: Improved Early Childhood Development in Rwanda

A study testing FSI ECD in people with Child Development, run by Boston College at 1 site in Rwanda.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Preliminary pilot testing of the home-based FSI-ECD intervention as delivered by community based lay workers. Read more about this study

Who is it for?
Ages 6 to 36 months
Conditions the study is for
Child Development
What is being tested?
FSI ECD
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteRwanda
Study dates
10 Mar 2017to 10 Mar 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 36 months
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Beneficiary Inclusion Criteria: All participants must live in chosen District(s) of Rwanda. Inclusion criteria for families are: (a) being VUP-eligible, (b) having at least one children aged 6-36 months living in the home and (c) having caregiver willing to discuss and enhance their parenting practices by interacting with a home-visiting coach. Caregiver eligibility: (a) is aged 18 or older and cares for child(ren) and (b) lives in the same household as child(ren). We will enroll both single and dual caregiver families to reflect population dynamics. Legal guardians may be aunts, uncles, grandparents, or foster parents.
  • Community Based Lay Worker Exclusion Criteria: Community based workers selected to deliver the FSI-ECD intervention must: (a) live in the sector of beneficiary households they will deliver the intervention to, (b) be Rwanda, (c) be aged 18 or older; (d) be able to write, read, and count in local language; (e) be committed to young children and family values; (f) have the required amount of time to carry out the FSI-ECD intervention with a select number of households, (e) be recommended and approved by local community and authorities.

Who cannot join

  • Beneficiary Exclusion Criteria: Potential participants will be excluded if they do not live in chosen District of Rwanda, do not have children between the ages of 6 and 36 months living in their household for whom they are the primary caregiver, they are not eligible/enrolled in Rwanda's public works social protection program, VUP, or have severe cognitive impairments which preclude their ability to speak to the research questions under study. We will exclude families in the midst of crisis (e.g., a caregiver with active suicidal attempts or psychosis) and refer them to appropriate services.
  • Community Based Lay Worker Exclusion Criteria: Community based workers will not be selected to deliver the FSI-ECD intervention if they do/are not: (a) live in the sector of beneficiary households they will deliver the intervention to, (b) Rwanda, (c) aged 18 or older; (d) able to write, read, and count in local language; (e) committed to young children and family values; (f) have required amount of time to carry out the FSI-ECD intervention with a select number of households, (e) recommended and approved by local community and authorities.

Trial locations and contacts

1 site in 1 country.

Rwanda1 site

  • Rwamagana District

    Rubona

Other trials in Rwanda

About this study

Official title: Community Based Lay Worker Pilot of FSI-ECD

Preliminary pilot testing of the home-based FSI-ECD intervention as delivered by community based lay workers.

Read the detailed description

The Family Strengthening Intervention for early childhood development was created and piloted for feasibility and acceptability in an ongoing protocol #15440 with Harvard Internal Review Board titled, "Developing and Piloting a Quantitative Behavioral Assessment Battery, Estimating Prevalence of Mental Disability among HIV/AIDS-affected Youth, and Piloting an Adapted Mental Health Intervention for HIV/AIDS-Affected Children in Rwanda." Research personnel have been adapting the existing recruitment materials/sessions and 15 Module Manual (FSI-ECD) with a focus on making the manual and corresponding materials more user friendly for community based lay worker "coaches."

This preliminary testing will provide an opportunity to administer a planned full scale 1,000+ household cluster randomized control trial on a smaller scale in order to learn from our materials that have been adapted for community based lay workers. This will also allow us to test our supervision and training structures to make necessary adaptation ahead of the planned full scale trial.

After all beneficiary households have completed the FSI-ECD intervention, each community based lay worker will complete a qualitative and quantitative exit assessment of his/her experience delivering the intervention, as well as ongoing feedback during the administration of FSI-ECD; allowing for the intervention and support structure to be strengthened for future iterations.

Being tested
FSI ECD
Keywords
Child Development, Home Visiting, Parenting Program, Social Protection, Public Works

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FSI ECDOther

    Also called Family Strengthening Intervention for ECD

    Households will be visited by a trained community based lay worker on a weekly to biweekly basis to deliver the 15 module curriculum covering a range of topics from nutrition, water and sanitation, hygiene, early stimulation, conflict management, to good communication. The intervention seeks to promote healthy child development via active coaching to individual beneficiary households, delivering modules on a one on one basis and engaging all family members.

Study groups in NCT03455127
Study groupRoleWhat they receive
Classic Public Works as UsualNo interventionHalf of the sample will be eligible to receive or be receiving the Government of Rwanda's (GOR) flagship social protection programming, Vision 2020 Program (VUP). One component of this program is to provide cash for work opportunities for labor endowed vulnerable households, i.e. one able bodied adult. Vulnerable households are those in Poverty Level 1 category, the GOR's poverty classification system. Furthermore, this study will require households in the control group receiving classic public works as usual to have at least one child between the ages of 6 months to 36 months.
Classic Public Works + FSI ECDExperimentalHalf of the sample will receive the FSI ECD home visiting parenting program alongside the GOR's classic public works programming. These households will be in Poverty Level 1 with an able-bodied adult, thus eligible to receive or be received the GORs public works programming. They will have a child between 6 and 36 months at enrollment. Households will be visited by a trained community based lay worker on a weekly to biweekly basis to deliver the 15 module curriculum covering a range of topics from nutrition, water and sanitation, hygiene, early stimulation, conflict management, to good communication. The intervention seeks to promote healthy child development via active coaching to individual beneficiary households, delivering modules on a one on one basis and engaging all family members.
Receives: Other: FSI ECD

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Ages Stages Questionnaire-3

    Change in Child Communication, Fine Motor, Gross Motor, Problem Solving, and Personal Social Development

    Measured: 12 months/18 months

Secondary outcomes (10)

  1. Hopkins Symptoms Check List

    Change in Caregiver Mental Health

    Measured: 12 months/18 months

  2. Multiple Indicator Cluster Survey 5

    Change in Infant and Young Child Feeding Practices

    Measured: 12 months/18 months

  3. Rwanda Comprehensive Food Security and Vulnerability Analysis and Nutrition Survey

    Change in Assessing Household Food Security related to diversity of food and meal frequency

    Measured: 12 months/18 months

  4. Local Derived Scale

    Change in Family Trust and Unity

    Measured: 12 months/18 months

  5. System for Observing Family Therapy Alliances

    Interventionist Self-Report

    Measured: 12 months

  6. Difficulties in Emotional Regulation (DERS)

    Change in Caregiver Emotional Regulation

    Measured: 12 months/18 months

  7. Malawi Development Assessment Tool (MDAT)

    Change in Child Development Observational Measure for Fine Motor, Gross Motor and Language

    Measured: 12 months/18 months

  8. Home Observation for the Measurement of the Environment (HOME Inventory)

    Change in Home Environment

    Measured: 12 months/18 months

  9. Observation of Mother Child Interaction (OMCI)

    Change in Caregiver-Child Relationship/Stimulation

    Measured: 12 months/18 months

  10. Ages Stages Questionnaire Socio-Emotional

    Change in Child Socio-Emotional Development

    Measured: 12 months/18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Mar 2018
  2. Study start10 Mar 2017
  3. Primary completion10 Mar 2018
  4. Study completion10 Mar 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03455127
Sponsor's protocol ID
IRB-16 1570_Activity B
Acronym
FSI-ECD
Status last verified
May 2018
First submitted
9 Nov 2017
Last updated
31 May 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing FSI ECD in people with Child Development, run by Boston College at 1 site in Rwanda.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Rwanda. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ages Stages Questionnaire-3 (time frame: 12 months/18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03455127.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2018.

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