Parent-Child Relations Clinical Trial
Official title:
The Effect of Interaction-Based Early Education Program Applied to Grandparents on the Growth and Development of Grandchildren
Verified date | October 2023 |
Source | Marmara University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Enrolling by invitation |
Enrollment | 60 |
Est. completion date | December 30, 2024 |
Est. primary completion date | July 1, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 1 Day to 48 Months |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Turkey | Marmara University | Istanbul |
Lead Sponsor | Collaborator |
---|---|
Marmara University |
Turkey,
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. — View 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. — View 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. — View 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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | The effect of the program on Grandparent's role satisfaction by using the Parental Stress Scale | The change from baseline in the Parental Stress Scale scores of Grandparents after the Responsive Teaching Program applied. The Parental Stress Scale is a 5-point Likert-type scale consisting of 16 items. Scored with a maximum of 80 points with a minimum of 0, with high scores indicating parental stress | 12 month after intervention |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03905278 -
Parental Support Intervention in the Oncological Context
|
N/A | |
Completed |
NCT03411577 -
Development and Testing of a Jamaican Mother-daughter HIV Risk-reduction Program
|
N/A | |
Recruiting |
NCT06273228 -
Parenting Young Children in Pediatrics
|
N/A | |
Completed |
NCT03497663 -
VIA Family - Family Based Early Intervention Versus Treatment as Usual
|
N/A | |
Completed |
NCT04101799 -
Evaluation of the Parental Support Intervention For Our Children's Sake in Prisons in Sweden
|
N/A | |
Completed |
NCT01955551 -
Motivational Interviewing to Increase Parent Engagement in Preventive Parenting Programming
|
Phase 2 | |
Completed |
NCT01432756 -
A South African Pilot Worksite Parenting Program to Prevent HIV Among Adolescents
|
N/A | |
Recruiting |
NCT05706376 -
An Evidence-based Family Support Program for Parents and Children in Palestine: A Theory-based Intervention
|
N/A | |
Completed |
NCT05930535 -
Family-Focused Adolescent & Lifelong Health Promotion
|
N/A | |
Completed |
NCT03658122 -
Integrating Behavioral Treatment in Primary Care
|
N/A | |
Recruiting |
NCT06099262 -
GenPMTO Evaluation
|
||
Recruiting |
NCT04853888 -
ATTACH™ Program: Promoting Vulnerable Children's Health at Scale
|
N/A | |
Completed |
NCT04633434 -
Evaluation Study of Talk Parenting Skills
|
N/A | |
Recruiting |
NCT04627415 -
Project PEAK: Early Intervention for ADHD
|
N/A | |
Completed |
NCT04257331 -
Parent Training to Reduce Behavioral Problems in Children With Autism Spectrum Disorder in China
|
N/A | |
Withdrawn |
NCT05135507 -
The Effective Parenting Program (EPP)
|
N/A | |
Completed |
NCT03853564 -
Early Parenting Intervention: Bio-behavioral Outcomes in Infants With Neurodevelopmental Disabilities
|
N/A | |
Active, not recruiting |
NCT05264415 -
Intergenerational Transmission of Traumatic Stress
|
N/A | |
Completed |
NCT04342871 -
An Evaluation of the Fathers and Mothers With Cancer Communication Tool
|
N/A | |
Recruiting |
NCT04107506 -
The Supporting Early Learning Study
|
N/A |