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Clinical Trials/NCT03010306
NCT03010306
Completed
N/A

Pilot Community-based Development Intervention (CASITA) for Children With Neurodevelopmental Risk and Delay in Carabayllo, Lima, Peru

Brigham and Women's Hospital0 sites61 target enrollmentSeptember 2013

Overview

Phase
N/A
Intervention
Not specified
Conditions
Child Developmental Delay
Sponsor
Brigham and Women's Hospital
Enrollment
61
Primary Endpoint
Change in risk of delay, as measured by the EASQ
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

Building on an intervention for early child development from the SPARK Center in Boston, Socios En Salud (SES) pilot tested "CASITA" a community-based package to screen and treat young children (ages 1-3 years of age) diagnosed with neurodevelopment risk and delay in Carabayllo, Lima, Peru. Ministry of Health CHWs identified children with developmental delays within the clinics and community and delivered a structured early intervention that included parent coaching and social support. In order to test the hypothesis that CASITA improves early child development, caregiver, and home environment, dyads received either nutrition supplements alone, nutrition + "CASITA" early child development sessions individually, or CASITA in a group of 10 dyads.

Registry
clinicaltrials.gov
Start Date
September 2013
End Date
October 2015
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Adrianne Katrina Hart Nelson

Research Manager

Brigham and Women's Hospital

Eligibility Criteria

Inclusion Criteria

  • Age between 6 - 24 months of age;
  • Known primary caregiver (parent or legal guardian) living with child;
  • Living within the catchment area of the 6 Health Centers that comprise the study zone.
  • Screen positive for neurodevelopment delay ("at risk" or "delayed" in neurodevelopment based on Evaluation del Desarrollo Psicomotor (EEDP) assessment).
  • Be at risk by scoring \<45 on the Progress Out of Poverty Index.

Exclusion Criteria

  • A known medical condition that would make the child unresponsive to early intervention;
  • Family anticipates moving within the next three months.

Outcomes

Primary Outcomes

Change in risk of delay, as measured by the EASQ

Time Frame: baseline, 3 months

The Ages and Stages Questionnaire (ASQ) is an internationally-validated instrument that can be used to assess change in developmental risk over time. Fernald et al incorporated additional observation-based assessments and the following modifications: 1) addition of child observation exercises to allow for validity check of parent responses (original ASQ questions), and 2) the incorporation of ASQ questions from the next highest age range. The Extended Ages and Stages Questionnaire (EASQ) was utilized as an assessment tool to allow us to better quantify degree of risk at baseline (based on quintiles of scores). By incorporating ASQ questions from the next two highest age ranges, scores will be continuous across the study period of three. The EASQ has been applied to children in four countries, including 2,845 children in Peru.

Secondary Outcomes

  • Change in global HOME score(baseline, 3 months)
  • Change in HOME subscore of parent responsivity(baseline, 3 months)
  • Change in HOME subscore of parent involvement(baseline, 3 months)

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