Child DevelopmentFSIECDNCT03045640
Family Strengthening Intervention for Early Childhood Development (ECD)
A study testing FSI ECD in people with Child Development, run by Boston College.
Trial summary
Study activities were carried out to adapt and test a family-strengthening intervention to improve child development outcomes among families facing adversity in Rwanda. 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
- 55 participants
- Where
- No sites listed yet
- Study dates
- Oct 2014to Sep 2016
- 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
- Potential participants must live in the study catchment area
- Caregiver(s) raising a child between 6 and 3 years old and Ubudehe 1 or 2 (Rwanda's poverty classification system)
- We will enroll both single and dual caregiver families to reflect population dynamics.
- Legal guardians may be aunts, uncles, grandparents, or foster parents
Who cannot join
- Potential participants that do not live in the study catchment area
- Do not have at least one child between the ages of 0 and 3 living in their household for whom they are the primary caregiver
- Are not classified as Ubudehe 1 or 2
- Have severe cognitive impairments which preclude their ability to speak to the research questions under study
About this study
Official title: Adapting a Family Strengthening Intervention (FSI) to Improve Early Childhood Development (ECD) Outcomes
Study activities were carried out to adapt and test a family-strengthening intervention to improve child development outcomes among families facing adversity in Rwanda.
Read the detailed description
Qualitative research from past studies was used to adapt an existing family-strengthening intervention for HIV-AIDS affected families to extremely vulnerable families with children 0-3 in order to improve early childhood development outcomes. This small scale pilot was carried out to test the feasibility and acceptability of the intervention for extremely vulnerable families with young children in Rwanda.
In the first 10 families the intervention consisted of 21 modules, in the second iteration of the study with an additional 10 families, the curriculum was summarized into 15 modules. Modules were delivered by trained bachelor-level interventionists/home-visiting coaches and were delivered to families one on one in their respective homes. Modules were delivered on a weekly to biweekly basis and were flexible to the families needs and other responsibilities.
- Conditions
- Child Development
- Being tested
- FSI ECD
- Keywords
- ECD, parenting program, home visiting
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
The FSI ECD intervention was delivered in a structured curriculum format, covering a range of topics from health, water and sanitation, good hygiene, early stimulation, conflict resolution, to good communication. It was designed to improve vulnerable households home environment and engagement with their children in order to improve child development outcomes. The curriculum was delivered by bachelor-level trained staff with beneficiaries on an individual, one on one basis, using active coaching to promote child well being and behaviors with caregivers.
| Study group | Role | What they receive |
|---|---|---|
| FSI ECD | Experimental | Vulnerable Households (ubudehe 1 or 2) in the Government of Rwanda's poverty classification system, when categories ranged from 1 to 6; the system has since been restructured to have four categories only. Often a way to identify households for public works opportunities or other government assistance programs. For this arm, families had to be Ubudehe 1 or 2 and have a child aged 0-3 years. Households meeting these criteria in the catchment area(s) received the FSI ECD home-based parenting intervention from bachelor-level interventionists/"coaches." Receives: Other: FSI ECD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change: Ages and Stages Questionnaire
Child development
Measured: 12 months/18 months
Secondary outcomes (4)
Change: Hopkins Symptoms CheckList
Caregiver Mental Health
Measured: 12 months/18 months
Change: MICS-5
Water, Sanitation, and Hygeine
Measured: 12 months/18 months
Change: Rwanda Comprehensive Food Security and Vulnerability Analysis and Nutrition Survey
Household Food Security
Measured: 12 months/18 months
Change: Locally Derived Scale
Family Trust and Unity
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.
- First posted7 Feb 2017 (estimated)
- Study startOct 2014
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Child DevelopmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston College
- Sponsor type
- University, hospital or other
- Collaborators
- World Bank
- Responsible party
- Principal investigator, Theresa Betancourt, Boston College
- Investigators
- Theresa Betancourt, Sc.D, M.A., Principal investigator, Boston College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03045640
- Sponsor's protocol ID
- 15440_IVC
- Acronym
- FSIECD
- Status last verified
- May 2018
- First submitted
- 16 Dec 2016
- Last updated
- 31 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Desrosiers A, Saran I, Albanese AM, Antonaccio CM, Neville SE, Esliker R, Jambai M, Feika M, Betancourt TS. Task-sharing to promote caregiver mental health, positive parenting practices, and violence prevention in vulnerable families in Sierra Leone: a pilot feasibility study. BMC Psychiatry. 2024 Nov 11;24(1):787. doi: 10.1186/s12888-024-06209-w.
PubMed 39529061
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adapting a Family Strengthening Intervention (FSI) to Improve Early Childhood Development (ECD) Outcomes
- ClinicalTrials.gov ID
- NCT03045640
- Acronym / sponsor ID
- FSIECD / 15440_IVC
- Conditions
- Child Development
- Keywords
- ECD, parenting program, home visiting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Boston CollegeUniversity, hospital or other
- Collaborators
- World Bank
- Study start
- Oct 2014
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 7 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study activities were carried out to adapt and test a family-strengthening intervention to improve child development outcomes among families facing adversity in Rwanda.
Detailed description
Qualitative research from past studies was used to adapt an existing family-strengthening intervention for HIV-AIDS affected families to extremely vulnerable families with children 0-3 in order to improve early childhood development outcomes. This small scale pilot was carried out to test the feasibility and acceptability of the intervention for extremely vulnerable families with young children in Rwanda.
In the first 10 families the intervention consisted of 21 modules, in the second iteration of the study with an additional 10 families, the curriculum was summarized into 15 modules. Modules were delivered by trained bachelor-level interventionists/home-visiting coaches and were delivered to families one on one in their respective homes. Modules were delivered on a weekly to biweekly basis and were flexible to the families needs and other responsibilities.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FSI ECD | Experimental | Other: FSI ECDVulnerable Households (ubudehe 1 or 2) in the Government of Rwanda's poverty classification system, when categories ranged from 1 to 6; the system has since been restructured to have four categories only. Often a way to identify households for public works opportunities or other government assistance programs. For this arm, families had to be Ubudehe 1 or 2 and have a child aged 0-3 years. Households meeting these criteria in the catchment area(s) received the FSI ECD home-based parenting intervention from bachelor-level interventionists/"coaches." |
Who may qualify
- Ages
- 6 to 36 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Potential participants must live in the study catchment area
- Caregiver(s) raising a child between 6 and 3 years old and Ubudehe 1 or 2 (Rwanda's poverty classification system)
- We will enroll both single and dual caregiver families to reflect population dynamics.
- Legal guardians may be aunts, uncles, grandparents, or foster parents
Key exclusion criteria (4 listed)
- Potential participants that do not live in the study catchment area
- Do not have at least one child between the ages of 0 and 3 living in their household for whom they are the primary caregiver
- Are not classified as Ubudehe 1 or 2
- Have severe cognitive impairments which preclude their ability to speak to the research questions under study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FSI ECDAlso: Family Strengthening Intervention for ECDThe FSI ECD intervention was delivered in a structured curriculum format, covering a range of topics from health, water and sanitation, good hygiene, early stimulation, conflict resolution, to good communication. It was designed to improve vulnerable households home environment and engagement with their children in order to improve child development outcomes. The curriculum was delivered by bachelor-level trained staff with beneficiaries on an individual, one on one basis, using active coaching to promote child well being and behaviors with caregivers. | Other | FSI ECD |
Primary outcome
Change: Ages and Stages Questionnaire
Time frame: 12 months/18 months
Child development
4 secondary outcomes
Change: Hopkins Symptoms CheckList
Time frame: 12 months/18 months
Change: MICS-5
Time frame: 12 months/18 months
Change: Rwanda Comprehensive Food Security and Vulnerability Analysis and Nutrition Survey
Time frame: 12 months/18 months
Change: Locally Derived Scale
Time frame: 12 months/18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2018.
- Derived from this study: PubMed 39529061Desrosiers A, Saran I, Albanese AM, Antonaccio CM, Neville SE, Esliker R, Jambai M, Feika M, Betancourt TS. Task-sharing to promote caregiver mental health, positive parenting practices, and violence prevention in vulnerable families in Sierra Leone: a pilot feasibility study. BMC Psychiatry. 2024 Nov 11;24(1):787. doi: 10.1186/s12888-024-06209-w.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Theresa Betancourt, Sc.D, M.A. principal investigator
Boston College
Questions about this trial
What is this clinical trial studying?
A study testing FSI ECD in people with Child Development, run by Boston College.
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 4 inclusion and 4 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.
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?
Change: Ages and Stages Questionnaire (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 NCT03045640, which also lists 1 linked publication.
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.