Clinical trial NCT03010306: CASITA Intervention for Children at Risk of Delay in Carabayllo, Peru
Official title: Pilot Community-based Development Intervention (CASITA) for Children With Neurodevelopmental Risk and Delay in Carabayllo, Lima, Peru
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child Developmental Delay
Child Development
Community Health Workers
Low Income Population
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Grand Challenges Canada
name: Harvard University
name: Boston Children's Hospital
name: Boston Medical Center
name: Partners in Health
First posted: 2017-01-05
Enrollment: 61
Sex: ALL
Minimum age (years): 6
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Change in risk of delay, as measured by the EASQ
timeFrame: baseline, 3 months
Secondary outcomes:
measure: Change in global HOME score
timeFrame: baseline, 3 months
measure: Change in HOME subscore of parent responsivity
timeFrame: baseline, 3 months
measure: Change in HOME subscore of parent involvement
timeFrame: baseline, 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Socios En Salud, Peru
name: Leonid Lecca, MD
role: PRINCIPAL_INVESTIGATOR
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