Evaluation of a Group-based Parenting Intervention for Early Childhood

Status Active, not recruiting

Clinical Trial Summary

This implementation research study aims to evaluate the impact and implementation of a group-based parenting program for improving early child development and caregiver outcomes. This study is enrolling primary caregivers with children 0 to 24 months of age to promote caregiver knowledge and skills about nurturing care for young children and support caregiver psychosocial wellbeing. Parenting groups will leverage existing community group networks and be facilitated by trained volunteers for 20 total sessions (groups will meet twice a month for 10 months). ChildFund Kenya and its community partners will implement the program in Busia and Homabay counties. The research study design will involve a cluster-randomized controlled trial and a qualitative implementation evaluation. This research is being led by Emory University with funding from the Conrad N. Hilton Foundation.

Clinical Trial Description

This research has two study components and aims. First, a cluster-randomized controlled trial will be used to quantitatively estimate the effectiveness of the parenting program on early child development and caregiver outcomes. For the research study sample, villages in Busia and Homabay counties were randomly selected and randomly assigned in each county to either the intervention or waitlist control group. Villages in the intervention group will receive the parenting program first, while villages in the control group will receive the program after the completion of the research study. In total, 64 villages have been selected into this study. Then in each village, 10 primary caregivers with children 0-24 months of age will be enrolled into the study for a total of 640 caregiver-child dyads. A caregiver survey and observational assessment of early child development skills will be administered to study participants at baseline and endline to evaluate changes in outcomes between groups over time. Second, and following the completion of the program, qualitative in-depth interviews will be conducted with participants and various stakeholders (e.g., program participants, parenting group facilitators, community health volunteers, ChildFund program staff) to understand their roles and experiences with the parenting program as well as the challenges and successes to inform future implementation. This qualitative implementation evaluation will seek to identify the barriers and facilitators to program impact, quality delivery, scale-up, and sustainability. ;

Study Design

Related Conditions & MeSH terms

Child Development

Clinical Trial Details

NCT number	NCT06165315
Study type	Interventional
Source	Harvard School of Public Health (HSPH)
Contact
Status	Active, not recruiting
Phase	N/A
Start date	November 1, 2023
Completion date	October 30, 2024

View Details

See also
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	`NCT02800616` - The Healthy Elementary School of the Future	N/A
Completed	`NCT02539251` - Arabic Ages and Stages Questionnaire-III
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

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Evaluation of a Group-based Parenting Intervention for Early Childhood Development

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms