Feeding and Eating DisordersNCT06086639
A FOUR SESSION ONLINE OCCUPATIONAL THERAPY GROUP TRANINIG FOR MOTHERS OF CHILDREN WITH FEEDING PROBLEMS
A study testing Online Occupational Therapy Group Training in people with Feeding and Eating Disorders and Child Behavior Problem, run by Ankara Medipol University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Feeding and Eating Disorders, Child Behavior Problem, Feeding Behavior
- What is being tested?
- Online Occupational Therapy Group Training
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2022to 1 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Receiving special education and/or occupational therapy sessions due to any risk,
- Having any chronic disease or disability in their child.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Medipol University
Ankara, Ankara/ Altındağ, 06110
About this study
Official title: A PILOT TRIAL OF A FOUR SESSION ONLINE OCCUPATIONAL THERAPY GROUP TRANINIG FOR MOTHERS OF CHILDREN WITH FEEDING PROBLEMS
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.
- Conditions
- Feeding and Eating Disorders, Child Behavior Problem, Feeding Behavior, Online Intervention, Occupational Therapy
- Being tested
- Online Occupational Therapy Group Training
- Keywords
- feeding and eating disorders, mother-child relations, online group intervention, occupational therapy
- Medical subject headings
- Feeding and Eating Disorders, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online Occupational Therapy Group TrainingOther
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
| Study group | Role | What they receive |
|---|---|---|
| Research group; mothers receiving online occupational therapy group training | Experimental | 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 Receives: Other: Online Occupational Therapy Group Training |
| Control group; Participants in this group did not receive any occupational therapy intervention duri | No intervention | Participants in this group did not receive any occupational therapy intervention during the 4-week period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From enrollment to the end of treatment at 4 weeks
Secondary outcomes (1)
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
Measured: From enrollment to the end of treatment at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2023
- Study start1 Dec 2022
- Primary completion1 Mar 2023
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Feeding and Eating DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rukiye Begüm KOCA, Ankara Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06086639
- Sponsor's protocol ID
- RKOCA
- Status last verified
- Oct 2023
- First submitted
- 11 Oct 2023
- Last updated
- 17 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PILOT TRIAL OF A FOUR SESSION ONLINE OCCUPATIONAL THERAPY GROUP TRANINIG FOR MOTHERS OF CHILDREN WITH FEEDING PROBLEMS
- ClinicalTrials.gov ID
- NCT06086639
- Acronym / sponsor ID
- RKOCA
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Ankara Medipol UniversityUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 17 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Research group; mothers receiving online occupational therapy group training | Experimental | Other: Online Occupational Therapy Group TrainingParticipants 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 |
| Control group; Participants in this group did not receive any occupational therapy intervention duri | No intervention | –Participants in this group did not receive any occupational therapy intervention during the 4-week period. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- Receiving special education and/or occupational therapy sessions due to any risk,
- Having any chronic disease or disability in their child.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online Occupational Therapy Group TrainingIn 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 | Other | Research group; mothers receiving online occupational therapy group training |
Primary outcome
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
1 secondary outcome
Feeding Process Mother Attitudes Scale
Time frame: From enrollment to the end of treatment at 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2023.
- Individual participant dataSharing planned: Undecided. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online Occupational Therapy Group Training in people with Feeding and Eating Disorders and Child Behavior Problem, run by Ankara Medipol University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early Childhood Adaptive Eating Behavior Scale (time frame: From enrollment to the end of treatment at 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2023.