- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06266507
Examining the Effect of Occupational Therapy-Based Parent Coaching on Feeding Problems in Children With a Preterm Birth
Examining the Effect of Occupational Therapy-Based Parent Coaching on Feeding Problems in Children With a History of Premature Birth
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ankara/ Altındağ
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Ankara, Ankara/ Altındağ, Turkey (Türkiye), 06110
- Ankara Medipol University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Prematurity of the child (Birth week <37)
- The child is between 3-6 years old
- The mother must have the competence to use online platforms, technological tools and internet connection.
- The mother must have sufficient education to read, understand and fill out the scales.
- Mothers reporting complaints about feeding problems in their children
Exclusion Criteria:
- It may affect the child's feeding; Having a food allergy, disability, neurodevelopmental disease, chromosomal or structural anomalies
- The child is fed non-orally
- Being receiving occupational therapy, oral motor therapy or nutritional therapy at any center
- Not allowing practices such as video sharing, camera/audio sharing, and recording of sessions during the intervention.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Research Group
Mothers who will receive a 10-week occupational therapy-based parent coaching intervention will be included in this group.
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Occupational Therapy Based Parent Coaching intervention will last 10 sessions and will be carried out on the online platform.
Sessions are planned to last between 45-60 minutes.
The interviews to be held during the sessions are considered as the basic principles of parent coaching; It will be carried out in line with the principles of joint planning, observation, implementation, reflection and feedback.
This intervention aims to educate mothers on proper feeding strategies for their children and to enable them to carry out these practices independently.
Other Names:
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Other: Control Group
The control group will not receive an active intervention, but will be provided with an informative brochure on early childhood development.
Additionally, once the research is completed, the right to participate in the intervention will be granted.
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No active intervention will be made to the mothers in the target group; an informative brochure about early childhood development will be distributed.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Behavioral Pediatric Feeding Assessment Scale
Time Frame: The scale will be applied 3 times in total: at the beginning of the study, 10 weeks after the first evaluation and 4 weeks after the second evaluation.
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This scale will be used to evaluate children's nutritional problems.
Behavioral Pediatrics Feeding Assessment Scale (BPFAS) was developed by Crist and Napier Philips in 2001 and its original version consists of 35 questions.
The usage age range of the survey is between 9 months and 7 years, and it is the scale with the most comprehensive reliability and validity data among the nutrition surveys administered by parents for preschool children.
The questionnaire has good test-retest reliability and internal consistency, acceptable-to-good sensitivity, and good-to-excellent specificity.
The BPFAS is capable of screening for a broad spectrum of feeding difficulties (nutritional and textural selectivity, food refusal, and oral motor difficulties).
Turkish validity study by Önal et al.
It was made by in 2017.
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The scale will be applied 3 times in total: at the beginning of the study, 10 weeks after the first evaluation and 4 weeks after the second evaluation.
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Sensory Profile Questionnaire - Oral Sensory Processing Test
Time Frame: The scale will be applied 3 times in total: at the beginning of the study, 10 weeks after the first evaluation and 4 weeks after the second evaluation.
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This scale will be used to examine how children's oral sensory processing skills change before and after the intervention. Ergotherapist Prof. Sensory Profile of the individual developed by Winnie Dunn; It is a measurement tool used to evaluate sensory modulation, in other words, the tendency to respond to sensory stimuli during daily activities and which sensory systems affect daily life more. It is used in children between the ages of 3-10. The individual; The test, which is used to measure functional performance in daily living activities, sensory processing abilities and sensory processing effects, consists of 3 main sub-parameters (sensory processing, modulation and behavioral-emotional responses) and 9 factor scores consisting of these parameters. *In our study, it was decided to use only the oral sensory processing subtest of questionnaire. |
The scale will be applied 3 times in total: at the beginning of the study, 10 weeks after the first evaluation and 4 weeks after the second evaluation.
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Canadian Occupational Therapy Measurement (COPM)
Time Frame: The scale will be applied 3 times in total: at the beginning of the study, 10 weeks after the first evaluation and 4 weeks after the second evaluation.
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The Canadian Occupational Performance Measurement (COPM) is an outcome measure designed to identify changes in individuals' perceived performance and satisfaction levels over time in the areas of self-care, productivity, and leisure.
In the application of the COPM, the client is first interviewed and listed occupations they want to do, are expected to do, but are unable to do, or are dissatisfied with the way they are performed.
Performance and satisfaction levels are recorded before and after the intervention, allowing the difference between the two assessments to be calculated.
The COPM will be used in this study to determine participants' goals for the intervention and to examine changes in performance and satisfaction following the intervention for the identified occupations.
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The scale will be applied 3 times in total: at the beginning of the study, 10 weeks after the first evaluation and 4 weeks after the second evaluation.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Feeding Strategies Quesstionnaire
Time Frame: The scale will be applied 3 times in total: at the beginning of the study, 10 weeks after the first evaluation and 4 weeks after the second evaluation.
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This questionnaire will be used to measure whether mothers' feeding strategies have changed before and after the intervention.It is a scale developed by Berlin et al. in 2005 to measure parents' feeding strategies for their children. FSQ consists of 27 items and is administered to children between the ages of 2-6. FSQ; It consists of 6 subheadings: child control in eating, meal time, environment structure, family control in eating, release and coercive interventions. The FSQ scale includes answers ranging from 1 (strongly disagree) to 5 (strongly agree). It has been reported that the Feeding Strategies Scale can be used to evaluate child and parent feeding strategies regarding the prevention or treatment of pediatric feeding difficulties. A Turkish adaptation study was carried out by Meral in 2017, and the total Cronbach alpha value of the scale is 0.80. |
The scale will be applied 3 times in total: at the beginning of the study, 10 weeks after the first evaluation and 4 weeks after the second evaluation.
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Parental Self-Efficacy Scale
Time Frame: The scale will be applied 3 times in total: at the beginning of the study, 10 weeks after the first evaluation and 4 weeks after the second evaluation.
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This scale will be used to examine how parents' self-efficacy changes before and after parent coaching intervention. Parental Self-Efficacy Scale Guimond et al. It was developed by Cavkaytar et al. in 2005 and adapted into Turkish by Diken in 2007. It is a scale updated in 2014 and used to measure the self-efficacy perceptions of parents of children with disabilities regarding their parenting skills. The scale is a 7-point Likert-type rating scale and consists of a total of 17 items. The lowest score can be obtained from the scale, 17 points, and the highest score can be 119 points. As the score obtained from the scale increases, the level of self-efficacy also increases. Cronbach's Alpha internal consistency coefficient of the scale was found to be 0.95. |
The scale will be applied 3 times in total: at the beginning of the study, 10 weeks after the first evaluation and 4 weeks after the second evaluation.
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Gökçen Akyürek, Ph. D., Hacettepe University
Publications and helpful links
General Publications
- Walton K, Daniel AI, Mahood Q, Vaz S, Law N, Unger SL, O'Connor DL. Eating Behaviors, Caregiver Feeding Interactions, and Dietary Patterns of Children Born Preterm: A Systematic Review and Meta-Analysis. Adv Nutr. 2022 Jun 1;13(3):875-912. doi: 10.1093/advances/nmac017.
- Dev DA, Padasas I, Hillburn C, Stage VC, Dzewaltowski DA. Ecological Approach to Family-Style, Multilevel Child Care Intervention: Formative Evaluation Using RE-AIM Framework. J Nutr Educ Behav. 2022 Aug;54(8):728-744. doi: 10.1016/j.jneb.2022.03.005. Epub 2022 Jun 26.
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
Additional Relevant MeSH Terms
- Urogenital Diseases
- Mental Disorders
- Female Urogenital Diseases and Pregnancy Complications
- Signs and Symptoms, Digestive
- Obstetric Labor, Premature
- Obstetric Labor Complications
- Pregnancy Complications
- Pathological Conditions, Signs and Symptoms
- Behavior
- Signs and Symptoms
- Behavior, Animal
- Premature Birth
- Feeding and Eating Disorders
- Feeding Behavior
Other Study ID Numbers
- 169
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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