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

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ClinicalTrials.gov Identifier: NCT03010306
Recruitment Status : Completed
First Posted : January 5, 2017
Last Update Posted : January 16, 2017
Sponsor:
Collaborators:
Grand Challenges Canada
Harvard University
Boston Children’s Hospital
Boston Medical Center
Partners in Health
Information provided by (Responsible Party):
Adrianne Katrina Hart Nelson, 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.

Condition or disease Intervention/treatment Phase
Child Developmental Delay Child Development Community Health Workers Low Income Population Other: CASITA Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Community-based Development Intervention (CASITA) for Children With Neurodevelopmental Risk and Delay in Carabayllo, Lima, Peru
Study Start Date : September 2013
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Nutrition only
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
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
Other Names:
  • Child development coaching and social support in Lima Peru
  • Community-based intervention for children at risk of Neurodevelopment delay




Primary Outcome Measures :
  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 Outcome Measures :
  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".



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Ages Eligible for Study:   6 Months to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03010306


Sponsors and Collaborators
Brigham and Women's Hospital
Grand Challenges Canada
Harvard University
Boston Children’s Hospital
Boston Medical Center
Partners in Health
Investigators
Principal Investigator: Leonid Lecca, MD Socios En Salud, Peru

Additional Information:
Publications:
Caldwell, B. and R. Bradley, eds. Home Inventory Administration Manual. 3rd Edition ed. 2001, University of Arkansas at Little Rock: Little Rock, AR.
Schreiner, M., Progress out of Poverty Index: A Simple Poverty Score for Peru. 2008, Grameen Foundation: St Louis, MO.
Rodriquez, S., ed. Escala de evaluacion del desarollo psicomotor: 0 a 24 meses. 12th ed ed. 1996, Galdoc: Santiago, Chile.

Responsible Party: Adrianne Katrina Hart Nelson, Research Manager, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT03010306     History of Changes
Other Study ID Numbers: 2013P002554
First Posted: January 5, 2017    Key Record Dates
Last Update Posted: January 16, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No