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Completed

NCT Number: NCT03010306

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

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.

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Key information

Conditions

Child Developmental Delay Child Development Communication Disorders Community Health Workers Learning Disabilities Low Income Population Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurodevelopmental Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

6 month–24 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CASITA

Other

Other names: Child development coaching and social support in Lima Peru, Community-based intervention for children at risk of Neurodevelopment delay

Primary outcomes

  1. 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

  1. Change in global HOME score

    Time frame: baseline, 3 months

    The Infant Toddler Home Observation Measurement of the Environment (HOME) evaluates parenting and home influences on child development.

  2. Change in HOME subscore of parent responsivity

    Time frame: 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".

  3. Change in HOME subscore of parent involvement

    Time frame: 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".

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • Boston Children's Hospital
  • Boston Medical Center
  • Grand Challenges Canada
  • Harvard University
  • Partners in Health

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jan 5, 2017
Registry last updated
Jan 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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