NCT05370989

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2022

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 23, 2022

Completed
19 days until next milestone

First Posted

Study publicly available on registry

May 12, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

July 12, 2022

Status Verified

July 1, 2022

Enrollment Period

5 months

First QC Date

April 23, 2022

Last Update Submit

July 9, 2022

Conditions

Keywords

Parent schoolChildToddlerGrowth and Development

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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.

  • 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.

Study Arms (2)

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

Other: Technology-Based Parent School ProgramOther: ongoing treatment

Control group

ACTIVE COMPARATOR

the control group will continue to receive routine check-ups.

Other: ongoing treatment

Interventions

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.

Technology-Based Parent School Program.

Health service of the control group will ongoing.

Control groupTechnology-Based Parent School Program.

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

Central Study Contacts

Ahu CIRLAK, PhD Student

CONTACT

Ebru KILICARSLAN TORUNER, PhD, RN

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 23, 2022

First Posted

May 12, 2022

Study Start

September 1, 2022

Primary Completion

January 30, 2023

Study Completion

June 1, 2023

Last Updated

July 12, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share