GrandparentsNCT05916144
The Effect of Interaction-Based Early Education Program Applied to Grandparents on the Grandchildren's Health
A study testing Interaction-Based Early Education Program in people with Grandparents and Growth Disorders, run by Marmara University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 1 day to 48 monthsHealthy volunteers can take part
- Conditions the study is for
- Grandparents, Growth Disorders, Development, Child
- What is being tested?
- Interaction-Based Early Education Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2023to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 48 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Interaction-Based Early Education Program Applied to Grandparents on the Growth and Development of Grandchildren
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.
Read more
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.
Read the 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).
- 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.
- Group 2: The group whose primary caregivers are mothers only
- Conditions
- Grandparents, Growth Disorders, Development, Child, Feeding Behavior, Parent-Child Relations
- Being tested
- Interaction-Based Early Education Program
- Keywords
- Grandparents, Grandchild, Growth and Development, Interaction Based Early Education Program, Parent-Child Relations
- Medical subject headings
- Growth Disorders, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interaction-Based Early Education ProgramBehavioural
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Interaction-Based Early Education Program |
| Group 2 | No intervention | The group whose primary caregivers are mothers only |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 12 month after intervention
Secondary outcomes (1)
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
Measured: 12 month after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2023
- Study start1 Jul 2023
- Primary completion1 Jul 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for GrandparentsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mahmut caner us, Marmara University
- Investigators
- Perran Boran, Prof., Principal investigator, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05916144
- Sponsor's protocol ID
- 09.2023.824
- Status last verified
- May 2025
- First submitted
- 5 Jun 2023
- Last updated
- 13 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD can be shared with an acceptable reason
Publications
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.
PubMed 32784209Black 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.
PubMed 27717614Farrow 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.
PubMed 25064278Pulgaron 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.
PubMed 27505069Tanskanen 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.
PubMed 34616345
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Interaction-Based Early Education Program Applied to Grandparents on the Growth and Development of Grandchildren
- ClinicalTrials.gov ID
- NCT05916144
- Acronym / sponsor ID
- 09.2023.824
- 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
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 23 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
- 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.
- Group 2: The group whose primary caregivers are mothers only
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Behavioral: Interaction-Based Early Education ProgramThe 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. |
| Group 2 | No intervention | –The group whose primary caregivers are mothers only |
Who may qualify
- Ages
- 1 day to 48 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interaction-Based Early Education ProgramThe 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. | Behavioural | Group 1 |
Primary outcome
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
Time frame: 12 month after intervention
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.
The effect of the program on Grandchild's developmental progress by using the Age and Stage Questionnaire
Time frame: 12 month after intervention
The change from baseline in Age and Stage questionnaire scores of grandchildren after the Responsive Teaching Program applied to caregiver Grandparents.
1 secondary outcome
The effect of the program on Grandparent's role satisfaction by using the Parental Stress Scale
Time frame: 12 month after intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2025.
- Background: PubMed 32784209Chung 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.
- Background: PubMed 27717614Black 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.
- Background: PubMed 25064278Farrow 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.
- Background: PubMed 27505069Pulgaron 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.
- Background: PubMed 34616345Tanskanen 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.
- Individual participant dataSharing planned: No. IPD can be shared with an acceptable reason
Related trials for Grandparents
Recruiting
Grandparent Breastfeeding Education and Breastfeeding Outcomes
Breastfeeding, Promotion of Exclusive Breastfeeding Through Grandparent Breastfeeding Education
Not yet recruiting
Empowering Cardiovascular Health in Custodial Grandparents
Cardiovascular Disease (CVD) Risk Factors
Active, not recruiting
Using Structured Video Chat to Improve Relationships Between Young Children and Remote Grandparents
Child Development, Family Members
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Perran Boran, Prof. principal investigator
Marmara University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interaction-Based Early Education Program in people with Grandparents and Growth Disorders, run by Marmara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: 12 month after intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05916144, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2025.