Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2025-12-26 @ 4:11 AM
Study NCT ID:
NCT07050927
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-03
First Post:
2025-06-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Long-Term Effect of Online Occupational Therapy-Based Parent Training on Feeding Problems in Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000080146', 'term': 'Avoidant Restrictive Food Intake Disorder'}], 'ancestors': [{'id': 'D001068', 'term': 'Feeding and Eating Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 32}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-07-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-07-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-02', 'studyFirstSubmitDate': '2025-06-22', 'studyFirstSubmitQcDate': '2025-07-02', 'lastUpdatePostDateStruct': {'date': '2025-07-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adaptive Eating Behavior in Infancy Scale', 'timeFrame': 'T₀ - Baseline: Pre-training, first assessment after randomization T₁ - Post-intervention: Immediately after training completion T₂ - 6-month follow-up T₃ - 12-month follow-up', 'description': 'The Infant Adaptive Feeding Behavior Scale (IAFBS) was developed by Dilsiz and Dağ in 2018 to assess the eating behaviors of children aged 9 to 36 months. The scale consists of 20 items and four factors: "Reluctance," "Resistance," "Reaction to Main Meal Structure," and "Sensory-Related Food Refusal." Items 1-8 measure the reluctance factor; items 9-12 measure resistance; items 13-16 assess reactions to meal structure; and items 17-20 evaluate food refusal related to sensory issues.\n\nItems are rated on a 5-point Likert scale ranging from "Never" to "Always," scored as follows: never = 1, rarely = 2, sometimes = 3, usually = 4, always = 5. However, item 2 ("reaches spontaneously for food during meals") reflects a positive feeding behavior and is reverse-scored. All other items are scored in the standard direction.\n\nThe total score ranges from 20 to 100. Higher total and subscale scores indicate more severe feeding behavior problems in infants aged 9 to 36 months.'}, {'measure': 'Maternal Attitudes Scale in the Feeding Process', 'timeFrame': 'T₀ - Baseline: Pre-training, first assessment after randomization T₁ - Post-intervention: Immediately after training completion T₂ - 6-month follow-up T₃ - 12-month follow-up', 'description': 'This scale was developed in 2018 by Dilsiz and Dağ with the aim of identifying problematic areas in maternal attitudes during the feeding process, based on the interactional dimension of feeding between the mother and child. The Feeding Process Parental Attitude Scale (FPPAS) is used to assess the feeding-related attitudes of mothers with children aged 9 to 72 months. It is a 5-point Likert-type scale with response options ranging from "Never" to "Always." The scale consists of 27 items and includes the following subscales: Negative Emotional State During Meals, Attitudes Toward Inadequate/Unbalanced Nutrition, Negative Feeding Strategies, Forceful Feeding, and Reaction to Others\' Opinions. The total score ranges from 27 to 135. Higher scores on the total scale and subscales indicate a greater presence of problematic maternal attitudes regarding the feeding process.'}, {'measure': 'Parental Stress Scale', 'timeFrame': 'T₀ - Baseline: Pre-training, first assessment after randomization T₁ - Post-intervention: Immediately after training completion T₂ - 6-month follow-up T₃ - 12-month follow-up', 'description': 'The Parenting Stress Scale was developed by Aydoğan and Özbay in 2017 to measure the stress experienced by parents of typically developing children in relation to their parenting role. The scale consists of 18 items and has a single-factor structure that includes the parent, the parent-child relationship, and characteristics of the child. It is a Likert-type instrument rated from 0 ("Does not describe at all") to 4 ("Describes very well"). The total score ranges from 0 to 72, with higher scores indicating higher levels of parenting stress. The scale is easily applicable to parents who have at least one child and have completed primary education or higher.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pediatrics', 'early childhood', 'telerehabilitation', 'parent training', 'group training', 'occupational therapy', 'feeding', 'feeding difficulties', 'feeding problems'], 'conditions': ['Feeding Difficulties', 'Feeding Problems', 'Food Neophobia']}, 'descriptionModule': {'briefSummary': 'This study type is a clinical trial (randomized controlled longitudinal study). The primary purpose is to determine whether an online occupational therapy-based parent training program can prevent or reduce feeding problems, improve parental attitudes, and decrease parenting stress in mothers of infants.\n\nThe participant population includes female caregivers (mothers) of typically developing infants aged 18 to 24 months. All participants are healthy volunteers.\n\nThe main research questions this study aims to answer are:\n\nDoes online occupational therapy-based parent training reduce feeding problems in infants (e.g., food refusal, resistance, sensory-based rejection)? Does the training improve maternal attitudes related to feeding and reduce parenting-related stress? Comparison group: Researchers will compare the outcomes of mothers who receive the online training (intervention group) with those who receive no intervention (control group) to determine the effectiveness of the program.\n\nParticipants will be asked to:\n\nComplete baseline assessment forms prior to randomization\n\nIf in the intervention group:\n\nAttend a 4-week online group training program (one session per week) via a secure Zoom® platform Participate in follow-up assessments at 6 months and 12 months post-training\n\nAll participants (in both groups) will:\n\nComplete standardized assessment tools at three time points (baseline, 6-month follow-up, 12-month follow-up), including:\n\nSociodemographic Information Form Infant Adaptive Feeding Behavior Scale Feeding Process Parental Attitude Scale Parenting Stress Scale'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'genderBased': True, 'genderDescription': 'Individuals who identify as the mother or primary female caregiver of a typically developing infant aged 18-24 months are eligible to participate.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Mothers of typically developing infants aged between 18 and 24 months\n* Mothers who report a stress level of 7 or above on a visual analog scale regarding their child's feeding process\n* Mothers who have the necessary technical equipment to follow the occupational therapy training via online platforms\n\nExclusion Criteria:\n\n* Infants born prematurely or diagnosed with significant neurological or developmental conditions\n* Infants who receive any diagnosis during the intervention or follow-up period\n* Mothers in the intervention group who miss more than one training session\n* Mothers who are currently receiving or have previously received occupational therapy or feeding counseling"}, 'identificationModule': {'nctId': 'NCT07050927', 'briefTitle': 'Long-Term Effect of Online Occupational Therapy-Based Parent Training on Feeding Problems in Infants', 'organization': {'class': 'OTHER', 'fullName': 'Ankara Medipol University'}, 'officialTitle': 'Long-Term Effect of Online Occupational Therapy-Based Parent Training on Feeding Problems in Infants: A Randomized Controlled Longitudinal Study', 'orgStudyIdInfo': {'id': 'Decision No: 112'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Parent Training Group', 'description': 'Participants in this group will receive a 4-week online occupational therapy-based parent training via secure Zoom sessions. The training focuses on feeding skills development, sensory strategies, parenting attitudes, and stress management. Participants will complete assessments at baseline, 6 months, and 12 months using standardized tools to evaluate infant feeding behavior, parental attitudes, and parenting stress', 'interventionNames': ['Behavioral: Online occupational therapy group training']}, {'type': 'NO_INTERVENTION', 'label': 'Non-intervention Group', 'description': 'Participants in this group will not receive any intervention during the study period. They will complete the same assessments as the intervention group at baseline, 6 months, and 12 months to monitor changes in infant feeding behavior, parental attitudes, and parenting stress.'}], 'interventions': [{'name': 'Online occupational therapy group training', 'type': 'BEHAVIORAL', 'description': 'The intervention is a 4-week online parent training program based on occupational therapy principles, delivered via secure Zoom sessions once per week. Each session lasts approximately 60-75 minutes and focuses on topics such as feeding skill development, sensory-based feeding difficulties, responsive parenting strategies, and stress management techniques. The training includes interactive discussions and practical suggestions for daily feeding routines. Supporting materials, such as PDF slides and short demonstration videos, are shared with participants after each session. Attendance in at least three sessions is required to remain in the study.', 'armGroupLabels': ['Parent Training Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '0650', 'city': 'Ankara', 'state': 'Altındağ', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Rukiye Begüm Begüm Koca Şentürk, Lecturer', 'role': 'CONTACT', 'email': 'rukiye.koca@ankaramedipol.edu.tr', 'phone': '+9005354474849'}], 'facility': 'Ankara Medipol University', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'centralContacts': [{'name': 'Rukiye Begüm Begüm Koca Şentürk, Lecturer', 'role': 'CONTACT', 'email': 'rukiye.koca@ankaramedipol.edu.tr', 'phone': '+90535 447 48 49'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'IPD will not be shared to protect participant confidentiality and comply with ethical standards.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ankara Medipol University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer Rukiye Begüm Koca Şentürk', 'investigatorFullName': 'Rukiye Begüm KOCA', 'investigatorAffiliation': 'Ankara Medipol University'}}}}