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Feeding BehaviorNCT06266507

Examining the Effect of Occupational Therapy-Based Parent Coaching on Feeding Problems in Children With a Preterm Birth

A study testing Ergotherapy Based Parent Coaching and Informative Brochure Distribution in people with Feeding Behavior and Mother-Child Relations, run by Ankara Medipol University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Any age, women onlyHealthy volunteers can take part
What is being tested?
Ergotherapy Based Parent Coaching and Informative Brochure Distribution
Could I receive a placebo?
No, everyone receives an active treatment
How many people
39 participants
Where
1 siteTurkey (Türkiye)
Study dates
29 Jul 2024to 15 Aug 2025
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
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Ankara Medipol University

    Ankara, Ankara/ Altındağ, 06110

Other trials in Turkey (Türkiye)

About this study

Official title: Examining the Effect of Occupational Therapy-Based Parent Coaching on Feeding Problems in Children With a History of Premature Birth

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, Canadian Occupational Therapy Measure (COPM), 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.

Being tested
Ergotherapy Based Parent Coaching, Informative Brochure Distribution
Keywords
prematurity, feeding problems, occupational therapy, parent coaching
Medical subject headings
Feeding Behavior, Feeding and Eating Disorders, Premature Birth

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ergotherapy Based Parent CoachingBehavioural

    Also called Informative Brochure Distribution

    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.

  • Informative Brochure DistributionOther

    No active intervention will be made to the mothers in the target group; an informative brochure about early childhood development will be distributed.

Study groups in NCT06266507
Study groupRoleWhat they receive
Research GroupExperimentalMothers who will receive a 10-week occupational therapy-based parent coaching intervention will be included in this group.
Receives: Behavioral: Ergotherapy Based Parent Coaching
Control GroupOtherThe 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.
Receives: Other: Informative Brochure Distribution

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: The scale will be applied 3 times in total: at the beginning of the study (baseline), 10 weeks after the first evaluation (week 10) and 4 weeks after the second evaluation (week 14).

  2. 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.

    Measured: The scale will be applied 3 times in total: at the beginning of the study (baseline), 10 weeks after the first evaluation (week 10) and 4 weeks after the second evaluation (week 14).

  3. Canadian Occupational Therapy Measurement (COPM)

    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.

    Measured: The scale will be applied 3 times in total: at the beginning of the study (baseline), 10 weeks after the first evaluation (week 10) and 4 weeks after the second evaluation (week 14).

  4. 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.

    Measured: The scale will be applied 3 times in total: at the beginning of the study (baseline), 10 weeks after the first evaluation (week 10) and 4 weeks after the second evaluation (week 14).

  5. 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.

    Measured: The scale will be applied 3 times in total: at the beginning of the study (baseline), 10 weeks after the first evaluation (week 10) and 4 weeks after the second evaluation (week 14).

Secondary outcomes (1)

  1. Numerical Rating Scale

    In this study, satisfaction was assessed in parents in the intervention group during post-intervention (T1) and follow-up (T2) evaluations. A single-item 0-10 (0=not satisfied at all, 10=very satisfied) numerical rating scale was used to assess overall satisfaction with Occupational Therapy Based Parent Coaching.

    Measured: This assessment was planned to be applied to the intervention group in post-intervention (T1: week 10) and post-follow-up (T2: week 14) evaluations.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Feb 2024
  2. Study start29 Jul 2024
  3. Primary completion22 Jun 2025
  4. Study completion15 Aug 2025

Resources

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
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06266507
Sponsor's protocol ID
169
Status last verified
Aug 2026
First submitted
6 Feb 2024
Last updated
12 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 35157009

  • 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.

    PubMed 35768329

Questions about this trial

What is this clinical trial studying?

A study testing Ergotherapy Based Parent Coaching and Informative Brochure Distribution in people with Feeding Behavior and Mother-Child Relations, 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 4 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 12 Aug 2026. 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?

Behavioral Pediatric Feeding Assessment Scale (time frame: The scale will be applied 3 times in total: at the beginning of the study (baseline), 10 weeks after the first evaluation (week 10) and 4 weeks after the second evaluation (week 14).). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06266507, which also lists 2 linked publications.

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 12 Aug 2026.

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