- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06086639
A FOUR SESSION ONLINE OCCUPATIONAL THERAPY GROUP TRANINIG FOR MOTHERS OF CHILDREN WITH FEEDING PROBLEMS
A PILOT TRIAL OF A FOUR SESSION ONLINE OCCUPATIONAL THERAPY GROUP TRANINIG FOR MOTHERS OF CHILDREN WITH FEEDING PROBLEMS
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ankara/ Altındağ
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Ankara, Ankara/ Altındağ, Turkey, 06110
- Ankara Medipol University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Research group; mothers receiving online occupational therapy group training
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 |
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
|
|
No Intervention: Control group; Participants in this group did not receive any occupational therapy intervention duri
Participants in this group did not receive any occupational therapy intervention during the 4-week period.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Early Childhood Adaptive Eating Behavior Scale
Time Frame: From enrollment to the end of treatment at 4 weeks
|
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
|
From enrollment to the end of treatment at 4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Feeding Process Mother Attitudes Scale
Time Frame: From enrollment to the end of treatment at 4 weeks
|
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
|
From enrollment to the end of treatment at 4 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
State-Trait Anxiety Inventory
Time Frame: From enrollment to the end of treatment at 4 weeks
|
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
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From enrollment to the end of treatment at 4 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RKOCA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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