Child Development Clinical Trial
Official title:
Caregiver Interventions for Developmental Delays in Young Kenyan Children
Verified date | June 2024 |
Source | Indiana University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
In this study, the investigators will only administer the intervention to children known to have neurodevelopmental delays. By focusing on adapting the intervention to be only a clinic-based treatment, a small number of community members could be trained to administer the program and increase the potential for sustainability. If the clinic-based group sessions prove to be effective for young children with neurodevelopmental delays, this would help inform the key areas of fidelity needed to maintain effectiveness of the intervention. This study is a critical first step to evaluating the Care for Child Development Intervention (CCDI) program's potential as a cross-cultural intervention that is sustainable and effective for the children at highest risk for neurodevelopmental delay. These results will have significant impacts in improving early childhood neurodevelopment both in Kenya and worldwide.
Status | Completed |
Enrollment | 31 |
Est. completion date | September 30, 2019 |
Est. primary completion date | February 14, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Months to 24 Months |
Eligibility | Inclusion Criteria: - age 18-24 months - communicate in either English or Kiswahili - Score < 85 on one of the BSID-III subscales (mild/moderate/severe delay in cognitive, motor, or language). - Have a caregiver who can communicate in English or Kiswahili - Have a caregiver responsible for child's daily activities Exclusion Criteria: - Profound neurological impairment, such as severe cerebral palsy, deafness, or blindness preventing them from participating in the groups. |
Country | Name | City | State |
---|---|---|---|
Kenya | Moi University School of Medicine | Eldoret | Uasin Gishu |
Lead Sponsor | Collaborator |
---|---|
Indiana University |
Kenya,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Bayley Scales of Infant and Toddler Development, 3rd edition (BSID-III) scores | Measures cognitive, language, and motor development. Composite scores for cognitive (range of scores 55-145), language (range of scores 47-153), and motor (range of scores 46-154) development. Lower scores indicate worse development. Subscales (e.g. fine and gross motor for motor and expressive and receptive language for language) are summed to create the composite score. | Baseline, 6 months, 12 months | |
Secondary | Change In Perspectives around Child Development, gathered by Focus Group Discussions | Qualitative interviews with caregivers in Group 1, who will receive the intervention during the first 6 months of the study. Qualitative interviews will also be performed with Group 2 to see if there were any changes in perspectives on child development without the intervention | Baseline and 6 months | |
Secondary | Change In Perspectives around Child Development, gathered by Focus Group Discussions | Qualitative interviews with caregivers in Group 2, who will receive the intervention during the second 6 months of the study. Qualitative interviews will also be performed with Group 1 to see if there were any changes in perspectives on child development after the intervention has ceased | 6 months and 12 months | |
Secondary | Change in mother interactions, gathered by video-taped mother interactions | Coding of mother's interactions with children while waiting. We will compare Group 1, who will receive the intervention during the first 6 months, as well as Group 2, who will not be receiving the intervention during this interval | Baseline and 6 months | |
Secondary | Change in mother interactions, gathered by video-taped mother interactions | Coding of mother's interactions with children while waiting. We will compare Group 2, who will receive the intervention during the first 6 months, as well as Group 1, who had received the intervention but not longer is receiving it in the second 6 months. | 6 months and 12 months | |
Secondary | Change in Home Observations Measurement of the Environment (HOME) scores | Structured observations and questions performed in a families home. Subscales are as follows: Responsivity (score range 0-11), acceptance (0-8), organization (0-6), learning materials (0-9), involvement (0-6), variety (0-5). The lower scores indicate worse performance. These subscales are summed to give the total score. | Baseline, 6 months, 12 months | |
Secondary | Change in MacArthur-Bates Communication Developmental Inventory (CDI) scores | Language. Scale range is 0-100, with the lower scores indicating worse performance. No subscales will be used in this study. | Baseline, 6 months, 12 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT06315036 -
Effects of Developmental Gymnastics on Preschoolers' Motor Skills
|
N/A | |
Active, not recruiting |
NCT05143294 -
Conectar Jugando: Board Games in Elementary Classrooms (6-12 Years Old) to Improve Executive Functions
|
N/A | |
Completed |
NCT05267730 -
Conectar Jugando: Board Games in Rural Elementary Classrooms (6-12 Years Old) to Improve Executive Functions
|
N/A | |
Completed |
NCT03680157 -
Comparing Rater Reliability of Familiar Practitioners to Blinded Coders
|
||
Completed |
NCT00362076 -
The Role of Motion in Infants' Ability to Categorize
|
N/A | |
Recruiting |
NCT05525962 -
Vulnerability/Resilience Factors Influencing the Developmental Trajectories and Adaptive Methods of Children and Adolescents in Child Welfare System.
|
||
Completed |
NCT03232606 -
Physical Activity of Asthmatic Children
|
||
Completed |
NCT05955755 -
The Effect of Butterfly Vacuum Blood Collection Set and Standard Vacutanier Needle on the Level of Pain and Fear
|
N/A | |
Recruiting |
NCT04443855 -
WASH Benefits Child Development Follow up
|
N/A | |
Not yet recruiting |
NCT06335524 -
Infant-Maternal Partnership and Cognitive Training Study for Preterm Infants
|
N/A | |
Not yet recruiting |
NCT05783141 -
Prebiotic Effects in Healthy Toddlers
|
N/A | |
Completed |
NCT02451059 -
Reducing Socioeconomic Disparities in Health at Pediatric Visits
|
N/A | |
Completed |
NCT02539251 -
Arabic Ages and Stages Questionnaire-III
|
||
Completed |
NCT02800616 -
The Healthy Elementary School of the Future
|
N/A | |
Completed |
NCT02242539 -
Tools to Improve Parental Recognition of Developmental Deficits in Children
|
N/A | |
Completed |
NCT03010306 -
CASITA Intervention for Children at Risk of Delay in Carabayllo, Peru
|
N/A | |
Completed |
NCT01683565 -
Preemie Tots: A Pilot Study to Understand the Effects of Prematurity in Toddlerhood
|
Phase 4 | |
Completed |
NCT00989859 -
Photo-Plethysmographic Camera to Monitor Heart Rate, Respiration Rate and Oxygen Saturation in Infants
|
||
Recruiting |
NCT00980733 -
Efficacy of Micronutrient Fortified Yoghurt in School Children for Health Benefits
|
Phase 3 | |
Terminated |
NCT04347707 -
Building Regulation in Dual Generations
|
N/A |