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

NCT05916144 | Active Not Recruiting

• 1 other identifier: 09.2023.824
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Grandparents; Growth Disorders; Development, Child; Feeding Behavior; Parent-Child Relations

Keywords

Grandparents; Grandchild; Growth and Development; Interaction Based Early Education Program; Parent-Child Relations

Outcome Measures

Primary Outcomes (2)

• The effect of the program on progress in Grandchild's socio-emotional and behavioural development by using the Brief Infant Toddler Social Emotional Assessment tool

  The change from baseline in Brief Infant Toddler Social Emotional Assessment (BITSEA)problem subscale scores of grandchildren after the Responsive Teaching Program applied to caregiver Grandparents. BITSEA is a 42-item tool with 2 sub-scales: Problem (BITSEAP) and Competence (BITSEAc). Each item is scored as 0-1-2, with a maximum of 84 points and a minimum of 0 points. Higher total scores on BITSEAp indicate higher behavioural and emotional problems and lower total scores on BITSEAc indicate lower competency.

  12 month after intervention

• The effect of the program on Grandchild's developmental progress by using the Age and Stage Questionnaire

  The change from baseline in Age and Stage questionnaire scores of grandchildren after the Responsive Teaching Program applied to caregiver Grandparents.

  12 month after intervention

Secondary Outcomes (1)

• The effect of the program on Grandparent's role satisfaction by using the Parental Stress Scale

  12 month after intervention

Study Arms (2)

Group 1

EXPERIMENTAL

The group in which grandparents actively participate in baby care, Grandparents with a score of 6 and above in the One Day of Life (Annex-5) questionnaire will be included.

Behavioral: Interaction-Based Early Education Program

Group 2

NO INTERVENTION

The group whose primary caregivers are mothers only

Interventions

Interaction-Based Early Education Program BEHAVIORAL

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.

Group 1

Eligibility Criteria

• Age: 1 Day - 48 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Known to have neurological and/or developmental problems, with chronic disease,
• years or older or
• Those who refuse to participate in the study themselves or their families will be excluded from the study.

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University

Istanbul, 34899, Turkey (Türkiye)

Location

Related Publications (5)

• Chung EO, Hagaman A, LeMasters K, Andrabi N, Baranov V, Bates LM, Gallis JA, O'Donnell K, Rahman A, Sikander S, Turner EL, Maselko J. The contribution of grandmother involvement to child growth and development: an observational study in rural Pakistan. BMJ Glob Health. 2020 Aug;5(8):e002181. doi: 10.1136/bmjgh-2019-002181.

  PMID: 32784209 BACKGROUND

• Black MM, Walker SP, Fernald LCH, Andersen CT, DiGirolamo AM, Lu C, McCoy DC, Fink G, Shawar YR, Shiffman J, Devercelli AE, Wodon QT, Vargas-Baron E, Grantham-McGregor S; Lancet Early Childhood Development Series Steering Committee. Early childhood development coming of age: science through the life course. Lancet. 2017 Jan 7;389(10064):77-90. doi: 10.1016/S0140-6736(16)31389-7. Epub 2016 Oct 4.

  PMID: 27717614 BACKGROUND

• Farrow C. A comparison between the feeding practices of parents and grandparents. Eat Behav. 2014 Aug;15(3):339-42. doi: 10.1016/j.eatbeh.2014.04.006. Epub 2014 May 9.

  PMID: 25064278 BACKGROUND

• Pulgaron ER, Marchante AN, Agosto Y, Lebron CN, Delamater AM. Grandparent involvement and children's health outcomes: The current state of the literature. Fam Syst Health. 2016 Sep;34(3):260-269. doi: 10.1037/fsh0000212. Epub 2016 Aug 8.

  PMID: 27505069 BACKGROUND

• Tanskanen AO, Danielsbacka M, Hamalainen H, Sole-Auro A. Does Transition to Retirement Promote Grandchild Care? Evidence From Europe. Front Psychol. 2021 Sep 20;12:738117. doi: 10.3389/fpsyg.2021.738117. eCollection 2021.

  PMID: 34616345 BACKGROUND

MeSH Terms

Conditions

Growth Disorders; Feeding Behavior

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior, Animal; Behavior

Study Officials

• Perran Boran, Prof.

  Marmara University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Investigators and Outcome Assessors will be selected from medical students who did not have information about the allocation
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc Prof

Model Details: The study was designed as a mixed methodology with semi-structured qualitative components for the pilot study and for post-intervention effectiveness while creating the intervention program, quantitative including pre-intervention and post-intervention analyses through scales.

Study Record Dates

• First Submitted: June 5, 2023
• First Posted: June 23, 2023
• Study Start: July 1, 2023
• Primary Completion: July 1, 2025
• Study Completion: September 30, 2025
• Last Updated: May 13, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)