NCT06086639

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 11, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 17, 2023

Completed
Last Updated

October 17, 2023

Status Verified

October 1, 2023

Enrollment Period

3 months

First QC Date

October 11, 2023

Last Update Submit

October 16, 2023

Conditions

Keywords

feeding and eating disordersmother-child relationsonline group interventionoccupational therapy

Outcome Measures

Primary Outcomes (1)

  • 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

    From enrollment to the end of treatment at 4 weeks

Secondary Outcomes (1)

  • Feeding Process Mother Attitudes Scale

    From enrollment to the end of treatment at 4 weeks

Other Outcomes (1)

  • State-Trait Anxiety Inventory

    From enrollment to the end of treatment at 4 weeks

Study Arms (2)

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

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.

Interventions

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

Research group; mothers receiving online occupational therapy group training

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale; Mothers with children between the ages of 3-6 can participate.
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Receiving special education and/or occupational therapy sessions due to any risk,
  • Having any chronic disease or disability in their child.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Medipol University

Ankara, Ankara/ Altındağ, 06110, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Feeding and Eating DisordersFeeding Behavior

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsMental DisordersBehavior, AnimalBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

October 11, 2023

First Posted

October 17, 2023

Study Start

December 1, 2022

Primary Completion

March 1, 2023

Study Completion

June 1, 2023

Last Updated

October 17, 2023

Record last verified: 2023-10

Locations