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CASITA Intervention for Children at Risk of Delay in Carabayllo, Peru

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03010306
Enrollment
61
Registered
2017-01-05
Start date
2013-09-30
Completion date
2015-10-31
Last updated
2017-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Child Development, Child Developmental Delay, Community Health Workers, Low Income Population

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.

Interventions

OTHERCASITA

Sponsors

Grand Challenges Canada
CollaboratorOTHER
Harvard University
CollaboratorOTHER
Boston Children's Hospital
CollaboratorOTHER
Boston Medical Center
CollaboratorOTHER
Partners in Health
CollaboratorOTHER
Brigham and Women's Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
6 Months to 24 Months
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in risk of delay, as measured by the EASQbaseline, 3 monthsThe 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

MeasureTime frameDescription
Change in global HOME scorebaseline, 3 monthsThe Infant Toddler Home Observation Measurement of the Environment (HOME) evaluates parenting and home influences on child development.
Change in HOME subscore of parent responsivitybaseline, 3 monthsThis HOME subscore is defined in the manual as the extent to which the parent responds to the child's behavior including reinforcement for desired behavior and communication through words and actions.
Change in HOME subscore of parent involvementbaseline, 3 monthsThis HOME subscore is defined as parental acceptance of the child's behavior that is less than optimal and examines avoidance of undue restriction and punishment.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026