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
|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|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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.
- 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.
- 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".
- 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".
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
|Principal Investigator:||Leonid Lecca, MD||Socios En Salud, Peru|