Child RearingENCCINCT02534597
National Evaluation of Quality of Childcare (C0682)
A study testing Promotores Training, Delayed Promotores training and Caregiver training in people with Child Rearing and Mental Health Wellness 1, run by Duke University at 1 site in El Salvador.
Trial summary
This evaluation seeks to assess the impact of a training program on childcare center environments and child/caregiver wellbeing in El Salvador. Through a longitudinal, randomized control trial, over 200 childcare centers participating in the program will be assigned to various treatment arms receiving different… Read more about this study
- Who is it for?
- Ages 6 months to 4 yearsHealthy volunteers can take part
- Conditions the study is for
- Child Rearing, Mental Health Wellness 1, Health Behavior
- What is being tested?
- Promotores Training, Delayed Promotores training and Caregiver training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,923 participants
- Where
- 1 siteEl Salvador
- Study dates
- 1 Mar 2015to 30 Jun 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 months to 4 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children between the ages of 6 months-4 years old at baseline, who are currently attending government-run childcare centers in El Salvador, will be eligible for enrollment in this study. One parent/guardian and center caregiver for an enrolled child will also complete assessments.
- In the comparison group, for every 5th center-attending child enrolled, the nearest neighboring child between the ages of 6 months and 4 years at enrollment, and who does not attend the center, will be eligible for enrollment. One parent/guardian of the comparison child will also complete assessments.
Who cannot join
- Children with known disabilities, who are unlikely to show developmental changes over time, may be excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: National Evaluation of Quality of Childcare (ENCCI)
This evaluation seeks to assess the impact of a training program on childcare center environments and child/caregiver wellbeing in El Salvador. Through a longitudinal, randomized control trial, over 200 childcare centers participating in the program will be assigned to various treatment arms receiving different components of the program. A community comparison cohort will also be enrolled.
Read the detailed description
Whole Child International (WCI) is a U.S.-based non-governmental organization. Its focus is on improving the caregiving environments for vulnerable children by effecting changes within child care centers and orphanages.
This evaluation will assess the impact of an educational training and technical assistance program offered by WCI in collaboration with the El Salvadoran government. The program consists of a series of educational trainings (for local government officials, directors of childcare and residential centers, and center caregivers) and technical assistance including infrastructural changes within centers.
To evaluate this intervention, a longitudinal, randomized controlled trial will be used to assign participating centers to one of seven treatment arms that will receive different components of the intervention. A community comparison cohort will also be enrolled to identify selection effects as well as local norms and standards. The central research question is, "Does providing training for institution providers and caregivers improve child outcomes?"
Ethnographic research will also explore local cultural norms regarding child caregiving, and seek to understand how the intervention is received within communities.
- Conditions
- Child Rearing, Mental Health Wellness 1, Health Behavior
- Being tested
- Promotores Training, Delayed Promotores training, Caregiver training, Delayed caregiver training, Materials support
- Medical subject headings
- Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Promotores TrainingBehavioural
Delayed Promotores trainingBehavioural
Caregiver trainingBehavioural
Delayed caregiver trainingBehavioural
Materials supportBehavioural
Delayed materials supportBehavioural
Technical assistanceBehavioural
Delayed technical assistanceBehavioural
| Study group | Role | What they receive |
|---|---|---|
| pctm | Experimental | Receives the earliest Promotores training, followed by direct caregiver training, materials support, and technical assistance. Receives: Behavioral: Promotores Training; Behavioral: Caregiver training; Behavioral: Materials support; Behavioral: Technical assistance |
| p_ctm | Experimental | Receives the earliest Promotores training, followed by delayed caregiver training, delayed materials support, and delayed technical assistance. Receives: Behavioral: Promotores Training; Behavioral: Delayed caregiver training; Behavioral: Delayed materials support; Behavioral: Delayed technical assistance |
| _pmt | Experimental | Receives the delayed Promotores training, followed by receipt of materials support and technical assistance. Receives: Behavioral: Delayed Promotores training; Behavioral: Materials support; Behavioral: Technical assistance |
| _p_mt | Experimental | Receives the delayed Promotores training, followed by delayed receipt of materials support and technical assistance. Receives: Behavioral: Delayed Promotores training; Behavioral: Delayed materials support; Behavioral: Delayed technical assistance |
| _pct | Experimental | Receives the delayed Promotores training, followed by caregiver training and technical assistance. Receives: Behavioral: Delayed Promotores training; Behavioral: Caregiver training; Behavioral: Technical assistance |
| _p_ct | Experimental | Receives the delayed Promotores training, followed by delayed caregiver training and technical assistance. Receives: Behavioral: Delayed Promotores training; Behavioral: Delayed caregiver training; Behavioral: Delayed technical assistance |
| _pt | Experimental | Receives the delayed Promotores training, followed by technical assistance. Receives: Behavioral: Delayed Promotores training; Behavioral: Technical assistance |
| _p_t | Experimental | Receives the delayed Promotores training, followed by delayed technical assistance. Receives: Behavioral: Delayed Promotores training; Behavioral: Delayed technical assistance |
| _pc | Experimental | Receives the delayed Promotores training, followed by a full caregiver training only. Receives: Behavioral: Delayed Promotores training; Behavioral: Caregiver training |
| _p_c | Experimental | Receives the delayed Promotores training, followed by delayed caregiver training. Receives: Behavioral: Delayed Promotores training; Behavioral: Delayed caregiver training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Children's developmental milestone achievement as measured by the Battelle Developmental Inventory, Second Edition (BDI-2).
The BDI-2 Developmental Quotient has a mean of 100, standard deviation of 15, score range 40-160.
Measured: Four years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2015 (estimated)
- Study start1 Mar 2015
- Primary completion30 Jun 2016
- Study completion30 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child RearingStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,923 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Whole Child International, University of South Carolina, University of Pittsburgh
- Responsible party
- Principal investigator, Jan Ostermann, Duke University
- Investigators
- Jan Ostermann, PhD, Principal investigator, Associate Research ProfessorKathryn Whetten, PhD, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02534597
- Sponsor's protocol ID
- 2017-0594
- Acronym
- ENCCI
- Status last verified
- Aug 2024
- First submitted
- 21 Aug 2015
- Last updated
- 7 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Evaluation of Quality of Childcare (ENCCI)
- ClinicalTrials.gov ID
- NCT02534597
- Acronym / sponsor ID
- ENCCI / 2017-0594
- Conditions
- Child Rearing, Mental Health Wellness 1, Health Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,923 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Whole Child International, University of South Carolina, University of Pittsburgh
- Study start
- 1 Mar 2015 (actual)
- Primary completion
- 30 Jun 2016 (actual)
- Study completion
- 30 Jun 2016 (actual)
- First posted
- 27 Aug 2015 (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 evaluation seeks to assess the impact of a training program on childcare center environments and child/caregiver wellbeing in El Salvador. Through a longitudinal, randomized control trial, over 200 childcare centers participating in the program will be assigned to various treatment arms receiving different components of the program. A community comparison cohort will also be enrolled.
Detailed description
Whole Child International (WCI) is a U.S.-based non-governmental organization. Its focus is on improving the caregiving environments for vulnerable children by effecting changes within child care centers and orphanages.
This evaluation will assess the impact of an educational training and technical assistance program offered by WCI in collaboration with the El Salvadoran government. The program consists of a series of educational trainings (for local government officials, directors of childcare and residential centers, and center caregivers) and technical assistance including infrastructural changes within centers.
To evaluate this intervention, a longitudinal, randomized controlled trial will be used to assign participating centers to one of seven treatment arms that will receive different components of the intervention. A community comparison cohort will also be enrolled to identify selection effects as well as local norms and standards. The central research question is, "Does providing training for institution providers and caregivers improve child outcomes?"
Ethnographic research will also explore local cultural norms regarding child caregiving, and seek to understand how the intervention is received within communities.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| pctm | Experimental | Behavioral: Promotores Training, Behavioral: Caregiver training, Behavioral: Materials support, Behavioral: Technical assistanceReceives the earliest Promotores training, followed by direct caregiver training, materials support, and technical assistance. |
| p_ctm | Experimental | Behavioral: Promotores Training, Behavioral: Delayed caregiver training, Behavioral: Delayed materials support, Behavioral: Delayed technical assistanceReceives the earliest Promotores training, followed by delayed caregiver training, delayed materials support, and delayed technical assistance. |
| _pmt | Experimental | Behavioral: Delayed Promotores training, Behavioral: Materials support, Behavioral: Technical assistanceReceives the delayed Promotores training, followed by receipt of materials support and technical assistance. |
| _p_mt | Experimental | Behavioral: Delayed Promotores training, Behavioral: Delayed materials support, Behavioral: Delayed technical assistanceReceives the delayed Promotores training, followed by delayed receipt of materials support and technical assistance. |
| _pct | Experimental | Behavioral: Delayed Promotores training, Behavioral: Caregiver training, Behavioral: Technical assistanceReceives the delayed Promotores training, followed by caregiver training and technical assistance. |
| _p_ct | Experimental | Behavioral: Delayed Promotores training, Behavioral: Delayed caregiver training, Behavioral: Delayed technical assistanceReceives the delayed Promotores training, followed by delayed caregiver training and technical assistance. |
| _pt | Experimental | Behavioral: Delayed Promotores training, Behavioral: Technical assistanceReceives the delayed Promotores training, followed by technical assistance. |
| _p_t | Experimental | Behavioral: Delayed Promotores training, Behavioral: Delayed technical assistanceReceives the delayed Promotores training, followed by delayed technical assistance. |
| _pc | Experimental | Behavioral: Delayed Promotores training, Behavioral: Caregiver trainingReceives the delayed Promotores training, followed by a full caregiver training only. |
| _p_c | Experimental | Behavioral: Delayed Promotores training, Behavioral: Delayed caregiver trainingReceives the delayed Promotores training, followed by delayed caregiver training. |
Who may qualify
- Ages
- 6 months to 4 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children between the ages of 6 months-4 years old at baseline, who are currently attending government-run childcare centers in El Salvador, will be eligible for enrollment in this study. One parent/guardian and center caregiver for an enrolled child will also complete assessments.
- In the comparison group, for every 5th center-attending child enrolled, the nearest neighboring child between the ages of 6 months and 4 years at enrollment, and who does not attend the center, will be eligible for enrollment. One parent/guardian of the comparison child will also complete assessments.
Key exclusion criteria (1 listed)
- Children with known disabilities, who are unlikely to show developmental changes over time, may be excluded from the 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 |
|---|---|---|
| Promotores Training | Behavioural | p_ctm, pctm |
| Delayed Promotores training | Behavioural | _p_c, _p_ct, _p_mt, _p_t, _pc, _pct, _pmt, _pt |
| Caregiver training | Behavioural | _pc, _pct, pctm |
| Delayed caregiver training | Behavioural | _p_c, _p_ct, p_ctm |
| Materials support | Behavioural | _pmt, pctm |
| Delayed materials support | Behavioural | _p_mt, p_ctm |
| Technical assistance | Behavioural | _pct, _pmt, _pt, pctm |
| Delayed technical assistance | Behavioural | _p_ct, _p_mt, _p_t, p_ctm |
Primary outcome
Children's developmental milestone achievement as measured by the Battelle Developmental Inventory, Second Edition (BDI-2).
Time frame: Four years
The BDI-2 Developmental Quotient has a mean of 100, standard deviation of 15, score range 40-160.
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 7 Aug 2024.
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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.
Jan Ostermann, PhD principal investigator
Associate Research Professor
Kathryn Whetten, PhD principal investigator
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Promotores Training, Delayed Promotores training and Caregiver training in people with Child Rearing and Mental Health Wellness 1, run by Duke University at 1 site in El Salvador.
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 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: finished, as of the sponsor's last update on 7 Aug 2024. 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 El Salvador. 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?
Children's developmental milestone achievement as measured by the Battelle Developmental Inventory, Second Edition (BDI-2). (time frame: Four years). 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 7 Aug 2024.