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

Study Overview
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Brief Summary
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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.

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

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

Intervention / Treatment
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* Other: CASITA


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 24 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Nutrition only<br>Monthly food baskets were provided to the nutrition only group. Food baskets included basic foods to sustain a family of three over one month's time, such as rice and evaporated milk. Food baskets were valued at approximately $28 US Dollars per basket. | |
| Active Comparator: Nutrition + CASITA<br>The CASITA intervention was given by a community health worker (CHW) and involves individual and group modalities. HOME-CASITA took place at the dyad's place of residence, and the GROUP-CASITA at a local community center. All CASITA participants received 12 weekly sessions over 3 months. Interventions retain core elements of the SPARK approach: coaching parents on child development stimulation and providing social support and encouragement. Each session is as follows: 1) Child observation & knowledge sharing about child development; 2) Practice of reciprocal attention focusing and social interaction activities; 3) Parent encouragement on behavior and developmental interactions; and 4) Parent social support through referral assistance, reassurance, and validation of parent's concerns. | Other: CASITA<br> <br> * Other names: Community-based intervention for children at risk of Neurodevelopment delay;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in risk of delay, as measured by the EASQ | 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. | baseline, 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in global HOME score | The Infant Toddler Home Observation Measurement of the Environment (HOME) evaluates parenting and home influences on child development. | baseline, 3 months | 
| Change in HOME subscore of parent responsivity | This 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. | baseline, 3 months | 
| Change in HOME subscore of parent involvement | This 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. | baseline, 3 months |