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A FOUR SESSION ONLINE OCCUPATIONAL THERAPY GROUP TRANINIG FOR MOTHERS OF CHILDREN WITH FEEDING PROBLEMS

Primary Purpose

Feeding and Eating Disorders, Child Behavior Problem, Feeding Behavior

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Online Occupational Therapy Group Training
Sponsored by
Ankara Medipol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Feeding and Eating Disorders focused on measuring feeding and eating disorders, mother-child relations, online group intervention, occupational therapy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Being a mother with a child between 37-72 months of age, Experiencing feeding problems with their child, Having the ability to understand the training and comprehend the scale items, Volunteering to participate, Having the competence to use online platforms, tools, and the internet connection. Exclusion Criteria: Receiving special education and/or occupational therapy sessions due to any risk, Having any chronic disease or disability in their child.

Sites / Locations

  • Ankara Medipol University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Research group; mothers receiving online occupational therapy group training

Control group; Participants in this group did not receive any occupational therapy intervention duri

Arm Description

Participants in this group received online occupational therapy group training for 1 hour per week for 4 weeks. Session-1 Defining the problem Understanding the causes Oral motor structures and anomalies Discussion Session-2 Feedback sharing The relationship between feeding and sensory integration Recognizing the symptoms of sensory integration Disorders Strategies for sensory integration disorders Discussion Session-3 Feedback sharing Parent behaviors and attitudes Behavioral strategies for feeding problems Discussion Session-4 Feedback sharing Self-compassion and self-regulation Cope with stress Discussion Review of outputs

Participants in this group did not receive any occupational therapy intervention during the 4-week period.

Outcomes

Primary Outcome Measures

Early Childhood Adaptive Eating Behavior Scale
Early Childhood Adaptive Eating Behavior Scale (ECAEBS), which was developed in 2018. The scale has a Cronbach's alpha value of 0.89, indicating good internal consistency, and a test-retest reliability coefficient of 0.96, indicating good stability over time. The scale consists of 20 items that are filled out by the caregiver and are rated on a 5-point Likert scale ranging from "Never" to "Always". The ECAEBS assesses various sub-factors, including "Reluctance," "Sensory-Related Rejection to Eat," "Aggression," and "Response to Main Meal Order." The total score of the scale can range from 20 to 100, with higher scores indicating a higher level of problems related to eating behaviors. An increase in scores for each sub-factor and the total score indicates an increase in feeding-related difficulties

Secondary Outcome Measures

Feeding Process Mother Attitudes Scale
Feeding Process Mother Attitudes Scale (FPMAS) to evaluate the attitudes of mothers in the process of feeding their children. This scale was developed in 2018 to assess mothers' feelings, thoughts, and approaches regarding the feeding process, specifically focusing on the interactional dimension of feeding with the mother. The FPMAS has a high internal consistency with a Cronbach's alpha value of 0.91 and good stability over time with a test-retest reliability coefficient of 0.94. The FPMAS is designed to evaluate the attitudes of mothers who have children between 9 months and 72 months old about the feeding process. It consists of 27 items rated on a 5-point Likert scale ranging from "Never" to "Always". The scale includes several sub-factors: "Negative Mood During Meal," "Attitudes towards Inadequate/Imbalanced Nutrition," "Negative Feeding Strategies," "Forced Feeding," and "Response to the Opinion of Others.". The total score on the FPMAS can range from 27 to 135

Full Information

First Posted
October 11, 2023
Last Updated
October 16, 2023
Sponsor
Ankara Medipol University
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1. Study Identification

Unique Protocol Identification Number
NCT06086639
Brief Title
A FOUR SESSION ONLINE OCCUPATIONAL THERAPY GROUP TRANINIG FOR MOTHERS OF CHILDREN WITH FEEDING PROBLEMS
Official Title
A PILOT TRIAL OF A FOUR SESSION ONLINE OCCUPATIONAL THERAPY GROUP TRANINIG FOR MOTHERS OF CHILDREN WITH FEEDING PROBLEMS
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
December 1, 2022 (Actual)
Primary Completion Date
March 1, 2023 (Actual)
Study Completion Date
June 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ankara Medipol University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Feeding problems such as selective eating, loss of appetite, and mealtime behavior problems are common in childhood. Parents play a primary role in learning about feeding, and difficulties experienced in this process may cause the parent to experience stress, despair and exhibit incorrect attitudes. The aim of this study is to examine the effect of online occupational therapy group training for mothers on mothers' attitudes and stress levels, and children's eating behaviors. Mothers of children aged 3-6 years with feeding problems (n=29) were randomly divided into groups. Early Childhood Adaptive Eating Behavior Scale, Feeding Process Mother Attitudes Scale and State-Trait Anxiety Inventory scales were used for evaluation. The mothers in the research group participated in the 4-week training. As a result of the research, positive effects were found on mothers' attitudes and children's eating behaviors (p<0.05). There was no change in mothers' state and trait anxiety levels (p>0.05). This study shows that online group training to mothers can support existing therapies and guides clinicians working in the field.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Feeding and Eating Disorders, Child Behavior Problem, Feeding Behavior, Online Intervention, Occupational Therapy
Keywords
feeding and eating disorders, mother-child relations, online group intervention, occupational therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Research group; mothers receiving online occupational therapy group training
Arm Type
Experimental
Arm Description
Participants in this group received online occupational therapy group training for 1 hour per week for 4 weeks. Session-1 Defining the problem Understanding the causes Oral motor structures and anomalies Discussion Session-2 Feedback sharing The relationship between feeding and sensory integration Recognizing the symptoms of sensory integration Disorders Strategies for sensory integration disorders Discussion Session-3 Feedback sharing Parent behaviors and attitudes Behavioral strategies for feeding problems Discussion Session-4 Feedback sharing Self-compassion and self-regulation Cope with stress Discussion Review of outputs
Arm Title
Control group; Participants in this group did not receive any occupational therapy intervention duri
Arm Type
No Intervention
Arm Description
Participants in this group did not receive any occupational therapy intervention during the 4-week period.
Intervention Type
Other
Intervention Name(s)
Online Occupational Therapy Group Training
Intervention Description
In this study, a 4-week online occupational therapy group training was conducted by an occupational therapist specialized in the field of nutrition. The content of the training, which takes place one hour a week, is given below; Session-1 Defining the problem Understanding the causes Oral motor structures and anomalies Discussion Session-2 Feedback sharing The relationship between feeding and sensory integration Recognizing the symptoms of sensory integration Disorders Strategies for sensory integration disorders Discussion Session-3 Feedback sharing Parent behaviors and attitudes Behavioral strategies for feeding problems Discussion Session-4 Feedback sharing Self-compassion and self-regulation Cope with stress Discussion Review of outputs
Primary Outcome Measure Information:
Title
Early Childhood Adaptive Eating Behavior Scale
Description
Early Childhood Adaptive Eating Behavior Scale (ECAEBS), which was developed in 2018. The scale has a Cronbach's alpha value of 0.89, indicating good internal consistency, and a test-retest reliability coefficient of 0.96, indicating good stability over time. The scale consists of 20 items that are filled out by the caregiver and are rated on a 5-point Likert scale ranging from "Never" to "Always". The ECAEBS assesses various sub-factors, including "Reluctance," "Sensory-Related Rejection to Eat," "Aggression," and "Response to Main Meal Order." The total score of the scale can range from 20 to 100, with higher scores indicating a higher level of problems related to eating behaviors. An increase in scores for each sub-factor and the total score indicates an increase in feeding-related difficulties
Time Frame
From enrollment to the end of treatment at 4 weeks
Secondary Outcome Measure Information:
Title
Feeding Process Mother Attitudes Scale
Description
Feeding Process Mother Attitudes Scale (FPMAS) to evaluate the attitudes of mothers in the process of feeding their children. This scale was developed in 2018 to assess mothers' feelings, thoughts, and approaches regarding the feeding process, specifically focusing on the interactional dimension of feeding with the mother. The FPMAS has a high internal consistency with a Cronbach's alpha value of 0.91 and good stability over time with a test-retest reliability coefficient of 0.94. The FPMAS is designed to evaluate the attitudes of mothers who have children between 9 months and 72 months old about the feeding process. It consists of 27 items rated on a 5-point Likert scale ranging from "Never" to "Always". The scale includes several sub-factors: "Negative Mood During Meal," "Attitudes towards Inadequate/Imbalanced Nutrition," "Negative Feeding Strategies," "Forced Feeding," and "Response to the Opinion of Others.". The total score on the FPMAS can range from 27 to 135
Time Frame
From enrollment to the end of treatment at 4 weeks
Other Pre-specified Outcome Measures:
Title
State-Trait Anxiety Inventory
Description
State-Trait Anxiety Inventory (STAI), one of the most widely used scales in the health field, to assess the anxiety level of mothers. The STAI consists of two separate scales, each consisting of forty items, making a total of eighty items. The State Anxiety Inventory measures how the person feels at a certain moment, reflecting their current state of anxiety. On the other hand, the Trait Anxiety Inventory measures how the person generally feels, providing an insight into their overall trait anxiety. Both scales can be completed in a total of 20 minutes. The interpretation of scores is done based on the total score obtained from both inventories, which can range between 20 and 80. A high score indicates a high level of anxiety, while a low score indicates a low level of anxiety
Time Frame
From enrollment to the end of treatment at 4 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Female; Mothers with children between the ages of 3-6 can participate.
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Being a mother with a child between 37-72 months of age, Experiencing feeding problems with their child, Having the ability to understand the training and comprehend the scale items, Volunteering to participate, Having the competence to use online platforms, tools, and the internet connection. Exclusion Criteria: Receiving special education and/or occupational therapy sessions due to any risk, Having any chronic disease or disability in their child.
Facility Information:
Facility Name
Ankara Medipol University
City
Ankara
State/Province
Ankara/ Altındağ
ZIP/Postal Code
06110
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Concern that there is a risk of losing control of the data and that the data may be misused and unfair benefit may be obtained from the data.

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A FOUR SESSION ONLINE OCCUPATIONAL THERAPY GROUP TRANINIG FOR MOTHERS OF CHILDREN WITH FEEDING PROBLEMS

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