NCT02534597

Brief 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 components of the program. A community comparison cohort will also be enrolled.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,923

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 21, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 27, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2016

Completed
Last Updated

August 7, 2024

Status Verified

August 1, 2024

Enrollment Period

1.3 years

First QC Date

August 21, 2015

Last Update Submit

August 5, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    Four years

Study Arms (10)

pctm

EXPERIMENTAL

Receives the earliest Promotores training, followed by direct caregiver training, materials support, and technical assistance.

Behavioral: Promotores TrainingBehavioral: Caregiver trainingBehavioral: Materials supportBehavioral: Technical assistance

p_ctm

EXPERIMENTAL

Receives the earliest Promotores training, followed by delayed caregiver training, delayed materials support, and delayed technical assistance.

Behavioral: Promotores TrainingBehavioral: Delayed caregiver trainingBehavioral: Delayed materials supportBehavioral: Delayed technical assistance

_pmt

EXPERIMENTAL

Receives the delayed Promotores training, followed by receipt of materials support and technical assistance.

Behavioral: Delayed Promotores trainingBehavioral: Materials supportBehavioral: Technical assistance

_p_mt

EXPERIMENTAL

Receives the delayed Promotores training, followed by delayed receipt of materials support and technical assistance.

Behavioral: Delayed Promotores trainingBehavioral: Delayed materials supportBehavioral: Delayed technical assistance

_pct

EXPERIMENTAL

Receives the delayed Promotores training, followed by caregiver training and technical assistance.

Behavioral: Delayed Promotores trainingBehavioral: Caregiver trainingBehavioral: Technical assistance

_p_ct

EXPERIMENTAL

Receives the delayed Promotores training, followed by delayed caregiver training and technical assistance.

Behavioral: Delayed Promotores trainingBehavioral: Delayed caregiver trainingBehavioral: Delayed technical assistance

_pt

EXPERIMENTAL

Receives the delayed Promotores training, followed by technical assistance.

Behavioral: Delayed Promotores trainingBehavioral: Technical assistance

_p_t

EXPERIMENTAL

Receives the delayed Promotores training, followed by delayed technical assistance.

Behavioral: Delayed Promotores trainingBehavioral: Delayed technical assistance

_pc

EXPERIMENTAL

Receives the delayed Promotores training, followed by a full caregiver training only.

Behavioral: Delayed Promotores trainingBehavioral: Caregiver training

_p_c

EXPERIMENTAL

Receives the delayed Promotores training, followed by delayed caregiver training.

Behavioral: Delayed Promotores trainingBehavioral: Delayed caregiver training

Interventions

p_ctmpctm
_p_c_p_ct_p_mt_p_t_pc_pct_pmt_pt
_pc_pctpctm
_p_c_p_ctp_ctm
_pmtpctm
_p_mtp_ctm
_pct_pmt_ptpctm
_p_ct_p_mt_p_tp_ctm

Eligibility Criteria

Age6 Months - 4 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • Children with known disabilities, who are unlikely to show developmental changes over time, may be excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Whole Child International

San Salvador, El Salvador

Location

MeSH Terms

Conditions

Health Behavior

Interventions

Health Planning Technical Assistance

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Health PlanningHealth Care Economics and Organizations

Study Officials

  • Jan Ostermann, PhD

    Associate Research Professor

    PRINCIPAL INVESTIGATOR
  • Kathryn Whetten, PhD

    Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 21, 2015

First Posted

August 27, 2015

Study Start

March 1, 2015

Primary Completion

June 30, 2016

Study Completion

June 30, 2016

Last Updated

August 7, 2024

Record last verified: 2024-08

Locations