Technology-Based Parent School Program

July 9, 2022 updated by: Ebru Kilicarslan Toruner, Gazi University

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.

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
68

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Technology-Based Parent School Program.
Technology-Based Parent School Program. This program, developing parents' self-efficacy and parenting skills in child care with the Parent School Program
Other: Technology-Based Parent School Program
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.
Other: ongoing treatment
Health service of the control group will ongoing.
Active Comparator: Control group
the control group will continue to receive routine check-ups.
Other: ongoing treatment
Health service of the control group will ongoing.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Change in parent skill level after 3 months
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.
Toddler skill level 3 months after the beginning of the program.
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.
Change in parent self-efficacy compliance from baseline at 3 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Gazi University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 30, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 23, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 11, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 12, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 12, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 9, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 310472

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings