NCT06537271

Brief Summary

Introduction: Toilet training is the training that helps children gain control of their urine and stool while they are asleep and awake, and to recognize that they need to go to the toilet and relieve themselves without being reminded or helped.Toilet training is the training that helps children gain control of their urine and stool while they are asleep and awake, and to recognize that they need to go to the toilet and relieve themselves without being reminded or helped.Weaning is the gradual cessation of breastfeeding. For most mothers and their babies, weaning can be a very difficult situation. It is extremely important to support breastfeeding and to wean at a time that is convenient for the mother and baby. Purpose: This study aims to examine the effects of web-based animation-based education given to mothers with children aged 18-36 months on the level of awareness. Material Method:The research was planned as an experimental study with experimental and control groups.In collecting the data, "Personal Information Form", "Toilet Training Knowledge and Attitude Scale", "Autism Awareness Scale Mother Form", "Breastfeeding Termination Scale" and "Informed Voluntary Consent Form" will be used.The universe of the study will consist of parents with children between 18-36 months of age. The sample of the study was calculated using the GPower computer program. With the power analysis, it was found that a total of 70 patients should be included in the control group and the experimental group, 35 patients each, in the calculation made at the α = 0.05 error level, the effect size for large independent groups, d = 0.8 for the t test and 95% power of the study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

August 1, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 5, 2024

Completed
27 days until next milestone

Study Start

First participant enrolled

September 1, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2025

Completed
Last Updated

May 4, 2025

Status Verified

April 1, 2025

Enrollment Period

4 months

First QC Date

August 1, 2024

Last Update Submit

April 30, 2025

Conditions

Keywords

toilet trainingautismweaning ending

Outcome Measures

Primary Outcomes (3)

  • Autism Awareness Scale of Mothers of Preschool Children

    It consists of 23 questions on a 4-point Likert type (1=False, 2=Undecided, 3=Partially True, 4=Absolutely True). Possible scores range from 23 to 92. An increase in the total score indicates a higher level of awareness. Cronbach's alpha value was 0.947 and it was determined that it had a two-factor structure (Behavioral Patterns and Communication and Interaction).

    for 8 weeks, once a week

  • Toilet Training

    It was developed to assess mothers' knowledge and attitudes towards toilet training. The scale consists of 29 Likert-type items, ranging from 1 to 5 (5-Strongly Agree, 4-Agree, 3-Don't Know, 2-Disagree, 1-Strongly Disagree), which measure mothers' preferences for agreeing or disagreeing with toilet training 25 knowledge and attitudes. The scale does not contain reverse items or scoring. A minimum of 1 and a maximum of 5 points can be obtained from the scale items. As the scale score increases, mothers' knowledge and attitudes towards Toilet Training increase positively.

    for 8 weeks, once a week

  • Readiness to Stop Breastfeeding

    It is a 5-point Likert-type scale (1 = Strongly Disagree, 2 = Disagree, 3 = Somewhat Agree, 4 = Agree, 5 = Strongly Agree). It can be applied to all mothers with babies 18 months and older. Items 2, 5, 13, 15, and 16 on the scale need to be reverse coded. The total score that can be obtained from the scale varies between 19-95. As the scores obtained from the scale increase, it is interpreted that the level of Readiness to Stop Breastfeeding increases.

    for 8 weeks, once a week

Study Arms (2)

experimental group

EXPERIMENTAL

Participation in the study is entirely voluntary. After the purpose of the study is explained to the experimental group by the researcher and written and verbal permission is obtained from those who voluntarily agree to participate in the study, the pre-test data will be collected by the researcher.

Combination Product: experimental group

Control Group

EXPERIMENTAL

After the purpose of the study is explained to the control group by the researcher and written and verbal permission is obtained from those who voluntarily agree to participate in the study, the pre-test data will be collected by the researcher.At the end of 8 weeks, the researcher will fill out the questionnaire forms for the experimental group and collect post-test data.

Combination Product: Control Group

Interventions

experimental groupCOMBINATION_PRODUCT

Autism awareness, breastfeeding cessation and toilet training knowledge and attitude training guide and weekly training content animation videos will be prepared for the experimental group and uploaded via WhatsApp and training will be provided. All participants will be interviewed face to face before the training and the necessary information about our study will be provided. Feedback will be received from the researcher regarding the videos, and participants in the study will be able to ask their questions via WhatsApp and share digital content in a digital environment. Evaluation will be made by conducting group work with individuals. Reminders such as mobile phone messages will be used. Training will be carried out within an 8-week program. Each week, training videos on the topics prepared in line with the training guide will be prepared and shared via WhatsApp. Feedback will be received by creating interactive communication environments.

experimental group
Control GroupCOMBINATION_PRODUCT

After the purpose of the study is explained to the control group by the researcher and written and verbal permission is obtained from those who voluntarily agree to participate in the study, the pre-test data will be collected by the researcher.At the end of the training, survey forms will be filled out by the researcher for the control group and post-test data will be collected.

Control Group

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Volunteering to Participate in the Study
  • Parents with children between 18-36 months of age who agree to participate in the study
  • Being literate in Turkish
  • Having a computer or mobile phone and internet connection at home
  • Being able to use Whatsapp
  • Not having a visual or auditory health problem that would prevent participation in the study
  • Not having a communication barrier

You may not qualify if:

  • Having a visual or auditory health problem that would prevent participation in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Iğdır University

Iğdır, 76000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Autistic DisorderBreast Feeding

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Autism Spectrum DisorderChild Development Disorders, PervasiveNeurodevelopmental DisordersMental DisordersFeeding BehaviorBehavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist. Prof. Principal Investigator

Study Record Dates

First Submitted

August 1, 2024

First Posted

August 5, 2024

Study Start

September 1, 2024

Primary Completion

January 1, 2025

Study Completion

February 1, 2025

Last Updated

May 4, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations