Child DevelopmentNCT02718287
Evaluation of the Home Visiting Pilot Program on Early Childhood Outcomes in Fortaleza Brazil
A study testing Home visiting intervention PCCSF (220 clusters) and Home visiting without PCCSF (220 clusters) in people with Child Development, run by Inter-American Development Bank.
Trial summary
This is a cluster-randomized study of a home visiting program targeting mothers of children 0 to 2.5 years of age with the objective of improving global child development. The program, Programa Cresça com Seu Filho (PCCSF), will be randomized across 220 microareas in the poorest Region (V) of the state of Fortaleza… Read more about this study
- Who is it for?
- Ages 1 day to 28 months
- Conditions the study is for
- Child Development
- What is being tested?
- Home visiting intervention PCCSF (220 clusters) and Home visiting without PCCSF (220 clusters)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,520 participants
- Where
- No sites listed yet
- Study dates
- Mar 2016to Oct 2017
- 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 1 day to 28 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Mothers of children ages 0-2.5 years of age
- Included in the poverty registry CadastroUnico
- Residents of specific 440 poor microareas of Region V of Fortaleza
Who cannot join
- Data will not be collected if parental consent not given.
About this study
Official title: Evaluation of the Home Visiting Pilot Programa Cresça Com Seu Filho (PCCSF) on Early Childhood Outcomes: a Cluster-Randomized Trial in Fortaleza Brazil
This is a cluster-randomized study of a home visiting program targeting mothers of children 0 to 2.5 years of age with the objective of improving global child development. The program, Programa Cresça com Seu Filho (PCCSF), will be randomized across 220 microareas in the poorest Region (V) of the state of Fortaleza, Brazil.
Read the detailed description
This is an evaluation of pilot program, Programa Cresça com Seu Filho (PCCSF) which is publically funded and, developed in a partnership between the Ministry of Health (MoH) of Brazil and the municipal government of Fortaleza. The program targets low-income mothers of children 0 to 2.5 years old, living in low-income neighborhoods in Fortaleza Brazil. The home visits are carried out by community health workers (CHW), who currently work for the Ministry of Health as part of the program Programa Saúde da Família. The CHWs will be trained on the PCCSF curriculum in order to provide 1-hour visits with the early stimulation package during two years. The PCCSF home visiting program is planned to begin implementation the week of March 15, 2016 for half of the community health workers and April 15, 2016 for the other half.
- Conditions
- Child Development
- Being tested
- Home visiting intervention PCCSF (220 clusters), Home visiting without PCCSF (220 clusters)
- Keywords
- language development, socio-emotional development, cognitive development, motor skills
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home visiting intervention PCCSF (220 clusters)Behavioural
Low income mothers of children 0-2.5 years of age in the randomized treatment micro-areas will receive home visits by community health workers trained in the PCCSF curriculum in addition to the basic health curriculum. The community health workers are supervised by trained and experienced nurses.
Home visiting without PCCSF (220 clusters)Behavioural
Low income mothers of children 0-2.5 years of age in the randomized control micro-areas will receive home visits by community health workers trained in the standard basic health curriculum (no PCCSF).
| Study group | Role | What they receive |
|---|---|---|
| Treatment: | Experimental | Home visiting with PCCSF Receives: Behavioral: Home visiting intervention PCCSF (220 clusters) |
| Control | Experimental | Home visiting no PCCSF Receives: Behavioral: Home visiting without PCCSF (220 clusters) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Denver Developmental Screening Test II- aggregate rating of language skills
language development
Measured: change from baseline to follow-up at 18 months
Denver Developmental Screening Test II - aggregate rating of socioemotional skills
socioemotional development
Measured: change from baseline to follow-up at 18 months
Denver Developmental Screening Test II -aggregate rating motor skills
motor development
Measured: change from baseline to follow-up at 18 months
Denver Developmental Screening Test II -aggregate rating cognitive skills
cognitive development
Measured: change from baseline to follow-up at 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionOct 2017 (estimated)
- Study completionOct 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2,520 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inter-American Development Bank
- Sponsor type
- University, hospital or other
- Collaborators
- Municipal Secretary of Health, Fortaleza Brasil, Universidade Federal do Ceara
- Responsible party
- Sponsor
- Investigators
- Florencia Lopez Boo, Ph.D., Principal investigator, Inter-American Development BankCristiana Ferreira da Silva, Ph.D., Principal investigator, Secretaria Municipal de Saúde de FortalezaMarcia Rocha, M.A., Principal investigator, Inter-American Development BankSuzanne Duryea, P.h.D., Principal investigator, Inter-American Development Bank
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02718287
- Sponsor's protocol ID
- IDB-2016-BR-1
- Status last verified
- Mar 2016
- First submitted
- 9 Mar 2016
- Last updated
- 30 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Home Visiting Pilot Programa Cresça Com Seu Filho (PCCSF) on Early Childhood Outcomes: a Cluster-Randomized Trial in Fortaleza Brazil
- ClinicalTrials.gov ID
- NCT02718287
- Acronym / sponsor ID
- IDB-2016-BR-1
- Conditions
- Child Development
- Keywords
- language development, socio-emotional development, cognitive development, motor skills
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,520 participants (estimated)
- Lead sponsor
- Inter-American Development BankUniversity, hospital or other
- Collaborators
- Municipal Secretary of Health, Fortaleza Brasil, Universidade Federal do Ceara
- Study start
- Mar 2016
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Oct 2017 (estimated)
- First posted
- 24 Mar 2016 (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.
This is a cluster-randomized study of a home visiting program targeting mothers of children 0 to 2.5 years of age with the objective of improving global child development. The program, Programa Cresça com Seu Filho (PCCSF), will be randomized across 220 microareas in the poorest Region (V) of the state of Fortaleza, Brazil.
Detailed description
This is an evaluation of pilot program, Programa Cresça com Seu Filho (PCCSF) which is publically funded and, developed in a partnership between the Ministry of Health (MoH) of Brazil and the municipal government of Fortaleza. The program targets low-income mothers of children 0 to 2.5 years old, living in low-income neighborhoods in Fortaleza Brazil. The home visits are carried out by community health workers (CHW), who currently work for the Ministry of Health as part of the program Programa Saúde da Família. The CHWs will be trained on the PCCSF curriculum in order to provide 1-hour visits with the early stimulation package during two years. The PCCSF home visiting program is planned to begin implementation the week of March 15, 2016 for half of the community health workers and April 15, 2016 for the other half.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment: | Experimental | Behavioral: Home visiting intervention PCCSF (220 clusters)Home visiting with PCCSF |
| Control | Experimental | Behavioral: Home visiting without PCCSF (220 clusters)Home visiting no PCCSF |
Who may qualify
- Ages
- 1 day to 28 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Mothers of children ages 0-2.5 years of age
- Included in the poverty registry CadastroUnico
- Residents of specific 440 poor microareas of Region V of Fortaleza
Key exclusion criteria (1 listed)
- Data will not be collected if parental consent not given.
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 |
|---|---|---|
| Home visiting intervention PCCSF (220 clusters)Low income mothers of children 0-2.5 years of age in the randomized treatment micro-areas will receive home visits by community health workers trained in the PCCSF curriculum in addition to the basic health curriculum. The community health workers are supervised by trained and experienced nurses. | Behavioural | Treatment: |
| Home visiting without PCCSF (220 clusters)Low income mothers of children 0-2.5 years of age in the randomized control micro-areas will receive home visits by community health workers trained in the standard basic health curriculum (no PCCSF). | Behavioural | Control |
Primary outcome
Denver Developmental Screening Test II- aggregate rating of language skills
Time frame: change from baseline to follow-up at 18 months
language development
Denver Developmental Screening Test II - aggregate rating of socioemotional skills
Time frame: change from baseline to follow-up at 18 months
socioemotional development
Denver Developmental Screening Test II -aggregate rating motor skills
Time frame: change from baseline to follow-up at 18 months
motor development
Denver Developmental Screening Test II -aggregate rating cognitive skills
Time frame: change from baseline to follow-up at 18 months
cognitive development
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2016.
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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.
Florencia Lopez Boo, Ph.D. principal investigator
Inter-American Development Bank
Cristiana Ferreira da Silva, Ph.D. principal investigator
Secretaria Municipal de Saúde de Fortaleza
Marcia Rocha, M.A. principal investigator
Inter-American Development Bank
Questions about this trial
What is this clinical trial studying?
A study testing Home visiting intervention PCCSF (220 clusters) and Home visiting without PCCSF (220 clusters) in people with Child Development, run by Inter-American Development Bank.
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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 30 Mar 2016. 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?
Results are not available in the source record.
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?
Denver Developmental Screening Test II- aggregate rating of language skills (time frame: change from baseline to follow-up at 18 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Mar 2016.