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Clinical Trials in Turkey / NCT05916144
Active, not recruiting Not applicable

The Effect of Interaction-Based Early Education Program Applied to Grandparents on the Grandchildren's Health

NCT05916144 · tracked via the Priya Life Science Turkey tracker
Phase
Not applicable
Started
2023-07-01
Last updated
2025-05-13

Condition(s) studied

GrandparentsGrowth DisordersDevelopment, ChildFeeding BehaviorParent-Child Relations

Investigational drug(s) / intervention(s)

Interaction-Based Early Education Program

Interaction-Based Early Education Program: The intervention program will be created based on the ETEÇOM model which is the Turkish adaptation of the Responsive Teaching Program developed in the United States. In this program, by improving the interactive behaviors of experts/educators or parents, the aim is for the child to acquire or develop 15 core behavior. Each session is planned to last between 60-90 minutes on average and will be conducted in a group format, consisting of 5 sessions, and can be conducted face-to-face or online.

Study summary

In our study, "Does the early childhood intervention applied to grandparents as caregivers affect the child's growth, development (cognitive and socio-emotional development), and nutrition? Does early childhood intervention apply to grandparents as caregivers have an impact on caregiving characteristics, grandparent's health, attachment, parenting role, psychosocial well-being, role satisfaction, and communication with the child? Is early childhood intervention applied to grandparents as caregivers effective in creating a common language between grandparents and mothers on child care issues?" the answers to these questions will be tried to be answered.

This randomized controlled study will be conducted between July 2023 and July 2024 with children aged 0-4 years and their parents/grandparents using a mixed methodology. Children between the ages of 0-4 will be included in the study group, and those who are only cared for by their grandparents will be included in the study group, and cared for by their parents will be included in the control group.

The study will consist of 2 stages. The first phase will be conducted with a pilot study group to establish the training program. After the 5-session program is administered, a qualitative analysis will be made and the program will be finalized according to the feedback.

In the second stage of the study, a pre-test will be done through questionnaires, and then a training program will be applied to the group with grandparents as caregivers. The post-test will be applied to each group 6-8 weeks after the 5-group session ends. Pre-test and post-tests will be created in the online Google survey format. Pre-tests will only be applied to grandparents and mothers. Post-tests will be carried out at 4 practice times (after 6-8 weeks, 6th, 9th, and 12th months after the end of the intervention) determined for the evaluation of both parental and childhood outcomes. The second qualitative analysis will be made in a group format with the grandparents who applied for the program and the mothers (parents) of those children. For the qualitative analysis, the pre-created semi-structured interview format will be used after obtaining the consent of the participants, and if they give their consent, a voice recording will be taken. Fathers will also be informed and encouraged to participate and will be included in the qualitative phase of the study if they give consent for participation.

Eligibility

Sex
ALL
Min age
1 Day
Max age
48 Months
Healthy volunteers
Accepted
Inclusion Criteria: Grandparents who have attended child care more than 2 times a week for at least 2 weeks and are known to continue to provide care support; Grandparents with grandchildren aged 0-4 who score 6 or higher on the "day of life" questionnaire will be included in the study group. The control group will consist of mothers who are the primary caregivers of healthy children aged 0-4. * Volunteer grandparents and mothers to be included in the study must be between the ages of 18-70. * Participants are required to know, understand and speak Turkish fluently. Exclusion Criteria: * Known to have neurological and/or developmental problems, with chronic disease, * 4 years or older or * Those who refuse to participate in the study themselves or their families will be excluded from the study.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Marmara University Istanbul Turkey (Türkiye)

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05916144 on ClinicalTrials.gov ↗ ← All trials in Turkey