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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05370989
Other study ID # 310472
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date September 1, 2022
Est. completion date June 1, 2023

Study information

Verified date July 2022
Source Gazi University
Contact Ahu CIRLAK, PhD Student
Phone 05556971356
Email ahu-c@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 68
Est. completion date June 1, 2023
Est. primary completion date January 30, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 45 Years
Eligibility 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 Design


Intervention

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.
ongoing treatment
Health service of the control group will ongoing.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Gazi University

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Change in parent skill level after 3 months
Primary 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. Toddler skill level 3 months after the beginning of the program.
Primary 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. Change in parent self-efficacy compliance from baseline at 3 months.
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