Growth and DevelopmentNCT05370989
Technology-Based Parent School Program
A study testing Technology-Based Parent School Program and ongoing treatment in people with Growth and Development and Child Rearing, run by Gazi University.
Trial summary
Objective: The purpose of this study was to assess the efficacy of a technology-based parent school program designed for parents of toddlers to be improved their parenting abilities. Design: A parallel group, randomized controlled trial. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Growth and Development, Child Rearing, Early Childhood Caries
- What is being tested?
- Technology-Based Parent School Program and ongoing treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2022to 1 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- to have given birth when you were 18 years and older
- to be parents whose children are between the ages of 16 and 21 months
- For the first time, having a child
- to be have internet access and smartphone or computer
- to agree to participate in the study
Who cannot join
- Parents who have a congenital defect, a chronic illness, or a mental disorder that their child has
- Prematurely born children
- Mothers who have been in their adolescents
Trial locations and contacts
No sites are listed yet.
Ebru KILICARSLAN TORUNER, PhD, RN contact
About this study
Official title: Technology-Based Parent School Program: Randomized Controlled Trial
Objective: The purpose of this study was to assess the efficacy of a technology-based parent school program designed for parents of toddlers to be improved their parenting abilities.
Design: A parallel group, randomized controlled trial. Method: The study will be conducted with parents whose children are between the ages of 18 and 24 months in a hospital's well-child outpatient clinic in Turkey. The study data will be analyzed using the Parent and Child Descriptive Data Form, the Parent Skill List, Toddler Skill List, and the Turkish Version of Self-Efficacy for Parenting Tasks Index-Toddler Scale. The program will be continued for 10 weeks in the intervention group and will be included five web-based modules, five online group interactions after each module, and consultation throughout the program and the follow-up period. The modules will be included topics such as the child's physical growth, cognitive and linguistic development, and social-emotional development. The modules will be supported by videos and messages. This study will be based on Meleis' Transition Theory.
Read more
Hypothesis:
H0-1: There is no difference in self-efficacy total scores of parents between intervention and control group.
H0-2: There is no difference in parenting skill list total scores between intervention and control group.
H0-3: There is no difference in the skill list total scores of toddlers according to the parents between intervention and control group.
H1-1: There is a difference in self-efficacy total scores of parents between intervention and control group.
H1-2: There is a difference in parenting skill list total scores between intervention and control group.
H1-3: There is a difference in the skill list total scores of toddlers according to the parents between intervention and control group.
- Being tested
- Technology-Based Parent School Program, ongoing treatment
- Keywords
- Parent school, Child, Toddler, Growth and Development
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Technology-Based Parent School ProgramOther
The program will be continued for 10 weeks in the intervention group and will be included five web-based modules, five online group interactions after each module, and consultation throughout the program and the follow-up period.
ongoing treatmentOther
Health service of the control group will ongoing.
| Study group | Role | What they receive |
|---|---|---|
| Technology-Based Parent School Program. | Experimental | Technology-Based Parent School Program. This program, developing parents' self-efficacy and parenting skills in child care with the Parent School Program Receives: Other: Technology-Based Parent School Program; Other: ongoing treatment |
| Control group | Active comparator | the control group will continue to receive routine check-ups. Receives: Other: ongoing treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parent Skill List
The form was created by the researchers by scanning the literature. Contains 25 items. For their children's physical, cognitive-language, and social-emotional development, the form includes skills that parents can do, cannot do, or are hesitant to do. Parents will receive a minimum of 0 and a maximum of 50 points.
Measured: Change in parent skill level after 3 months
Toddler Skill List
The form was created by the researchers by scanning the literature. Contains 15 items. The form will evaluate what skills they have and what they will be unable to do for the physical, cognitive-language, and social-emotional development of toddlers. Toddler will receive a minimum of 0 and a maximum of 30 points.
Measured: Toddler skill level 3 months after the beginning of the program.
the Turkish Version of Self-Efficacy for Parenting Tasks Index-Toddler Scale
The scale consists of 51 items to measure the self-efficacy of parents of children aged 1-3. The 5-point Likert-type scale is scored as 5: Totally Agree, 4: Agree, 3: Undecided, 2: Disagree, and 1: Strongly Disagree for positive items. Some of the items are scored reverse. The total score ranges from 51 to 255, with increasing scores indicating a high level of self-efficacy.
Measured: Change in parent self-efficacy compliance from baseline at 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2022
- Study start1 Sep 2022 (estimated)
- Primary completion30 Jan 2023 (estimated)
- Study completion1 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Growth and DevelopmentStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ebru Kilicarslan Toruner, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05370989
- Sponsor's protocol ID
- 310472
- Status last verified
- Jul 2022
- First submitted
- 23 Apr 2022
- Last updated
- 12 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cirlak A, Kilicarslan E. Technology-based parent school: A randomized controlled trial. Public Health Nurs. 2024 Sep-Oct;41(5):1188-1198. doi: 10.1111/phn.13371. Epub 2024 Jul 16.
PubMed 39010780
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Technology-Based Parent School Program: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05370989
- Acronym / sponsor ID
- 310472
- Keywords
- Parent school, Child, Toddler, Growth and Development
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (estimated)
- Primary completion
- 30 Jan 2023 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 12 May 2022 (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.
Objective: The purpose of this study was to assess the efficacy of a technology-based parent school program designed for parents of toddlers to be improved their parenting abilities.
Design: A parallel group, randomized controlled trial. Method: The study will be conducted with parents whose children are between the ages of 18 and 24 months in a hospital's well-child outpatient clinic in Turkey. The study data will be analyzed using the Parent and Child Descriptive Data Form, the Parent Skill List, Toddler Skill List, and the Turkish Version of Self-Efficacy for Parenting Tasks Index-Toddler Scale. The program will be continued for 10 weeks in the intervention group and will be included five web-based modules, five online group interactions after each module, and consultation throughout the program and the follow-up period. The modules will be included topics such as the child's physical growth, cognitive and linguistic development, and social-emotional development. The modules will be supported by videos and messages. This study will be based on Meleis' Transition Theory.
Hypothesis:
H0-1: There is no difference in self-efficacy total scores of parents between intervention and control group.
H0-2: There is no difference in parenting skill list total scores between intervention and control group.
H0-3: There is no difference in the skill list total scores of toddlers according to the parents between intervention and control group.
H1-1: There is a difference in self-efficacy total scores of parents between intervention and control group.
H1-2: There is a difference in parenting skill list total scores between intervention and control group.
H1-3: There is a difference in the skill list total scores of toddlers according to the parents between intervention and control group.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Technology-Based Parent School Program. | Experimental | Other: Technology-Based Parent School Program, Other: ongoing treatmentTechnology-Based Parent School Program. This program, developing parents' self-efficacy and parenting skills in child care with the Parent School Program |
| Control group | Active comparator | Other: ongoing treatmentthe control group will continue to receive routine check-ups. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- to have given birth when you were 18 years and older
- to be parents whose children are between the ages of 16 and 21 months
- For the first time, having a child
- to be have internet access and smartphone or computer
- to agree to participate in the study
Key exclusion criteria (3 listed)
- Parents who have a congenital defect, a chronic illness, or a mental disorder that their child has
- Prematurely born children
- Mothers who have been in their adolescents
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 |
|---|---|---|
| Technology-Based Parent School ProgramThe program will be continued for 10 weeks in the intervention group and will be included five web-based modules, five online group interactions after each module, and consultation throughout the program and the follow-up period. | Other | Technology-Based Parent School Program. |
| ongoing treatmentHealth service of the control group will ongoing. | Other | Control group, Technology-Based Parent School Program. |
Primary outcome
Parent Skill List
Time frame: Change in parent skill level after 3 months
The form was created by the researchers by scanning the literature. Contains 25 items. For their children's physical, cognitive-language, and social-emotional development, the form includes skills that parents can do, cannot do, or are hesitant to do. Parents will receive a minimum of 0 and a maximum of 50 points.
Toddler Skill List
Time frame: Toddler skill level 3 months after the beginning of the program.
The form was created by the researchers by scanning the literature. Contains 15 items. The form will evaluate what skills they have and what they will be unable to do for the physical, cognitive-language, and social-emotional development of toddlers. Toddler will receive a minimum of 0 and a maximum of 30 points.
the Turkish Version of Self-Efficacy for Parenting Tasks Index-Toddler Scale
Time frame: Change in parent self-efficacy compliance from baseline at 3 months.
The scale consists of 51 items to measure the self-efficacy of parents of children aged 1-3. The 5-point Likert-type scale is scored as 5: Totally Agree, 4: Agree, 3: Undecided, 2: Disagree, and 1: Strongly Disagree for positive items. Some of the items are scored reverse. The total score ranges from 51 to 255, with increasing scores indicating a high level of self-efficacy.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2022.
- Derived from this study: PubMed 39010780Cirlak A, Kilicarslan E. Technology-based parent school: A randomized controlled trial. Public Health Nurs. 2024 Sep-Oct;41(5):1188-1198. doi: 10.1111/phn.13371. Epub 2024 Jul 16.
- Individual participant dataSharing planned: No
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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.
Ebru KILICARSLAN TORUNER, PhD, RN contact
Questions about this trial
What is this clinical trial studying?
A study testing Technology-Based Parent School Program and ongoing treatment in people with Growth and Development and Child Rearing, run by Gazi University.
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 5 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: status not confirmed, as of the sponsor's last update on 12 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahu CIRLAK, PhD Student (05556971356, ahu-c@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parent Skill List (time frame: Change in parent skill level after 3 months). The study lists 3 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 NCT05370989, which also lists 1 linked publication.
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 12 Jul 2022.