Clinical trial NCT05916144: The Effect of Interaction-Based Early Education Program Applied to Grandparents on the Grandchildren's Health
Official title: The Effect of Interaction-Based Early Education Program Applied to Grandparents on the Growth and Development of Grandchildren
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
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
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2023-06-23
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 48
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

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.

Detailed description: Although the main focus in early childhood interventions is mother-child interaction, it is known that grandmothers are also culturally potential final decision makers in child care, especially in low- and low-middle-income countries (1). Therefore, given its role in child care, it has been emphasized that early childhood programs should offer a family-centred approach to child health by involving all key actors, including parents and grandmothers.

While studies have shown that the health of grandparents' grandchildren, and taking care of grandchildren from another point of view, have a mutual effect on the health of grandparents, it is also emphasized that more research needs to be done on this subject. In our study, "Does the early childhood intervention applied to grandparents as caregivers have an effect on 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 the questions will be tried to be answered.

This is a randomized controlled study to be conducted between July 2023 and July 2024 with children aged 0-4 years and their parents/grandparents using 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 parents will be included in the control group. 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.

The study announcement will be announced on both posters and social media, and those who meet the inclusion criteria will be included in the study. The study will consist of 2 stages. The first phase will be carried out with a pilot study group to establish the training program. After the 5-session program is created on the basis of ETEÇOM, a qualitative analysis will be made and the program will be finalized according to the feedback.

In the second stage of the study, participants who meet the inclusion criteria will be randomly distributed to both groups until they reach the minimum number determined at the time of application, 10% more than the minimum number. Before each group, a pre-test will be done through questionnaires, a training program will be applied to the group with grandparents as caregivers, and the post-test will be applied to each group 6-8 weeks after the end. 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 determined for the evaluation of both parental and childhood outcomes. In the last part of the study, qualitative analyzes will be made in a group format with the grandparents who applied for the program and the mothers (parents) of those children, and the study will be concluded. 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.

Childhood outcomes will be evaluated in a total of 5 assessment periods. The first evaluation is the pretest, and after the second quantitative and in-depth qualitative analyzes are performed 6-8 weeks after the end of the intervention, the childhood outcomes will be re-evaluated in the 6th, 9th, and 12th months (3rd, 4th, and 5th quantitative tests) after the intervention. The first-year outputs will be taken as the basis for the thesis data, and it is planned to follow the study outputs until the 48th month.

Considering similar studies, it was planned to include at least 30 people in each group (20).

1. Group 1: 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 in this group.
2. Group 2: The group whose primary caregivers are mothers only

Eligibility criteria: 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 outcomes:
measure: 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
timeFrame: 12 month after intervention
measure: The effect of the program on Grandchild's developmental progress by using the Age and Stage Questionnaire
timeFrame: 12 month after intervention
Secondary outcomes:
measure: The effect of the program on Grandparent's role satisfaction by using the Parental Stress Scale
timeFrame: 12 month after intervention
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Marmara University
Study officials:
affiliation: Marmara University
name: Perran Boran, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.