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

Not Applicable

Completed

• Conditions: Low Income Population; Child Developmental Delay; Child Development; Community Health Workers
• Interventions: Other: CASITA

• Registration Number: NCT03010306
• Lead Sponsor: Brigham and Women's Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Study First Submitted: 2016-12-20
• Status Verified: 2017-01
• Study First Submitted QC: 2017-01-03
• Study First Posted: 2017-01-05
• Last Update Submitted: 2017-01-12
• Last Update Posted: 2017-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nutrition + CASITA	CASITA	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.

Primary Outcome Measures

Name	Time	Method
Change in risk of delay, as measured by the EASQ	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 Outcome Measures

Name	Time	Method
Change in global HOME score	baseline, 3 months	The Infant Toddler Home Observation Measurement of the Environment (HOME) evaluates parenting and home influences on child development.
Change in HOME subscore of parent responsivity	baseline, 3 months	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".
Change in HOME subscore of parent involvement	baseline, 3 months	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".