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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06266507
Other study ID # 169
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date February 15, 2024
Est. completion date March 15, 2025

Study information

Verified date February 2024
Source Ankara Medipol University
Contact Rukiye B Koca, M.Sc.
Phone 5354474849
Email rukiye.koca@ankaramedipol.edu.tr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Feeding problems are common in children with a history of premature birth, and these problems continue into early childhood. Feeding problems are affected by many biopsychosocial factors, and the context in which feeding takes place and the attitudes and behaviors of parents can also be effective in the emergence or continuation of these problems. The aim of our study is to evaluate the effects of occupational therapy-based parent coaching intervention on mothers and their children, who are considered to be primarily responsible for the feeding of children in our country. 46 mothers with premature children will be included in our study and participants will be randomly assigned to intervention/control groups. Mothers will fill out a sociodemographic information form, Behavioral Pediatric Feeding Assessment Scale, Sensory Profile Questionnaire - Oral Sensory Processing Subtest, Family Feeding Strategies Scale and Parental Self-Efficacy Scale via Google forms. Mothers in the research group will be given online occupational therapy-based parent coaching training for 10 weeks. Second evaluations will be carried out after the training; Final evaluations will be applied after 1 month of follow-up.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 46
Est. completion date March 15, 2025
Est. primary completion date February 15, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group N/A and older
Eligibility 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 Design


Intervention

Behavioral:
Ergotherapy Based Parent Coaching
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:
Informative Brochure Distribution
No active intervention will be applied to mothers in the target group, and an informative brochure about nutritional problems will be distributed.

Locations

Country Name City State
Turkey Ankara Medipol University Ankara Ankara/ Altindag

Sponsors (1)

Lead Sponsor Collaborator
Ankara Medipol University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Behavioral Pediatric Feeding Assessment Scale 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. 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.
Primary Sensory Profile Questionnaire - Oral Sensory Processing Test 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.
Secondary Feeding Strategies Quesstionnaire 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.
Secondary Parental Self-Efficacy Scale 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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