Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-30 @ 12:02 AM
Study NCT ID:
NCT07468435
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-12
First Post:
2026-02-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of a Parenting Skills Training Program on Maternal Self-Efficacy, Perceived Social Support, and Infant Development in Mothers of Preterm Infants Aged 6-12 Months
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047928', 'term': 'Premature Birth'}], 'ancestors': [{'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 26}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-13', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-08-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-09', 'studyFirstSubmitDate': '2026-02-17', 'studyFirstSubmitQcDate': '2026-03-09', 'lastUpdatePostDateStruct': {'date': '2026-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Preterm Parenting & Self-efficacy Checklist', 'timeFrame': 'Assessment will be completed at baseline, after the 7 week training program and end of the one month follow-up period', 'description': "The Preterm Parenting \\& Self-Efficacy Checklist is a parent-reported assessment tool designed to evaluate parenting self-efficacy in caregivers of preterm infants. The checklist measures parents' beliefs and confidence in their ability to effectively manage caregiving tasks and parenting responsibilities related to their preterm infant.\n\nThe instrument consists of multiple items assessing key dimensions of parenting self-efficacy, including confidence in caregiving skills, perceived competence in managing infant needs, and the importance attributed to parenting tasks. Items are rated on a Likert-type scale, with higher scores indicating higher levels of perceived parenting self-efficacy.\n\nThe checklist has been developed specifically for parents of preterm infants and has demonstrated acceptable psychometric properties, including internal consistency and construct validity, in previous studies. It is suitable for use in clinical and research settings to assess changes in parenting sel"}, {'measure': 'Multidimensional Scale of Perceived Social Support', 'timeFrame': 'Assessment will be completed at baseline, after the 7 week training program and end of the one month follow-up period', 'description': "The Multidimensional Scale of Perceived Social Support (MSPSS) is a self-report questionnaire designed to assess an individual's perceived adequacy of social support from multiple sources. The scale evaluates perceived support from three distinct domains: family, friends, and a significant other.\n\nThe MSPSS consists of 12 items rated on a Likert-type scale, with higher scores indicating higher levels of perceived social support. Subscale scores can be calculated for each support source, as well as a total score representing overall perceived social support."}], 'secondaryOutcomes': [{'measure': 'Assessment of developmental level of children in five domains; gross motor, fine motor, communication, problem-solving, social skills.', 'timeFrame': 'Assessment will be completed at baseline, after the 7 week training program and end of the one month follow-up period', 'description': 'Ages and Stages Questionnaire ASQ will be used to assess developmental level of infants. ASQ is a standardized, parent-completed developmental screening tool used to assess the developmental status of infants and young children. It evaluates development across five domains: communication, gross motor, fine motor, problem solving, and personal-social skills.\n\nThe ASQ is designed for children aged 3 to 72 months and includes age-specific questionnaires that correspond to the child\'s corrected age. Each item is rated as "yes," "sometimes," or "not yet," with higher scores indicating more advanced developmental performance. Domain-specific cutoff scores are used to identify children at risk for developmental delay.'}, {'measure': 'Psychomotor, cognitive, language, and social-emotional developmental levels of infants.', 'timeFrame': 'Assessment will be completed at baseline, after the 7 week training program and end of the one month follow-up period', 'description': "The Gazi Early Childhood Assessment Tool (GEÇDA) is a standardized developmental assessment instrument used to evaluate the developmental functioning of infants and young children aged 0-72 months. The tool assesses development across four core domains: psychomotor, cognitive, language, and social-emotional development.\n\nGEÇDA consists of age-specific items organized into 21 developmental age intervals. Each item is scored dichotomously as achieved or not achieved, and developmental performance is determined by comparing the child's domain-specific raw scores with age-based normative data. Rather than producing a single total score, the tool provides a profile of developmental strengths and areas of concern across domains."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['parental self-efficacy', 'social support', 'preterm infants', 'parenting skills'], 'conditions': ['Prematurity']}, 'descriptionModule': {'briefSummary': "The goal of this clinical trial is to evaluate whether a structured parenting skills training intervention can improve maternal parenting self-efficacy, perceived social support, and infant developmental outcomes in mothers of preterm infants aged 6-12 months (corrected age).\n\nThe main questions it aims to answer are:\n\nDoes a parenting skills training intervention improve maternal parenting self-efficacy?\n\nDoes the intervention increase mothers' perceived social support and positively influence infant developmental levels?\n\nResearchers will compare mothers who receive the parenting skills training intervention with a control group receiving standard care to determine whether the intervention leads to greater improvements in maternal and infant outcomes.\n\nParticipants will:\n\nComplete baseline, post-intervention, and follow-up assessments of parenting self-efficacy and perceived social support\n\nHave their infants assessed using standardized developmental evaluation tools\n\nParticipate in a structured, home-based parenting skills training program consisting of multiple sessions (intervention group only)\n\nTake part in semi-structured interviews before and after the intervention to share their experiences and perceived needs", 'detailedDescription': 'Mothers of preterm infants frequently face prolonged caregiving demands, heightened stress, and challenges in adapting to parenting roles, which may adversely affect parenting self-efficacy, perceived social support, and early parent-infant interactions. These factors are closely linked to infant developmental outcomes, particularly during the first year of life, a critical period for neurodevelopment. Despite the recognized importance of early, family-centered interventions, evidence-based parenting programs specifically targeting mothers of preterm infants remain limited.\n\nThis study will employ a mixed-methods, randomized controlled design to examine the effectiveness of a structured Parenting Skills Training Intervention for mothers of preterm infants aged 6-12 months (corrected age). Eligible participants will be randomly assigned to either an intervention group or a control group. Quantitative assessments will be conducted at baseline (pre-test), immediately after the intervention (post-test), and at follow-up to evaluate the sustainability of intervention effects. Qualitative data will be collected through semi-structured interviews to explore maternal needs, experiences, and perceptions related to the intervention process.\n\nThe intervention will consist of a home-based parenting skills training program delivered in multiple structured sessions. The program is designed to provide mothers with practical knowledge and strategies related to responsive caregiving, infant development, and problem-solving in daily parenting situations. In addition to informational support, the intervention aims to strengthen maternal coping skills and perceived social support by addressing common caregiving challenges associated with prematurity and facilitating access to appropriate guidance and resources.\n\nPrimary outcome measures will include maternal parenting self-efficacy and perceived social support, assessed using validated self-report scales. Secondary outcomes will focus on infant developmental status, evaluated using standardized developmental screening and assessment tools covering motor, cognitive, communication, and social domains. The control group will receive standard care during the study period and will be offered the parenting skills training after completion of post-test assessments.\n\nBy integrating quantitative outcome measures with qualitative insights, this study aims to provide a comprehensive evaluation of a parenting skills training intervention tailored for mothers of preterm infants. The results are expected to inform early intervention practices, contribute to the development of family-centered support models, and guide professionals working with preterm infants and their caregivers in clinical and community settings'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Months', 'minimumAge': '6 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* For Mothers Being able to read and write in Turkish Providing written informed consent Having a preterm infant with a corrected age between 6 and 12 months Not having a diagnosed psychiatric disorder\n* For Infants Being born preterm between week of 32 and 37 Not presenting any neurological or other conditions Having a corrected age between 6 and 12 months\n\nExclusion Criteria:\n\n* For Mothers Having any neurological, musculoskeletal and psychiatric diagnosis to effect the caregiving role\n* For Infants Use of multiple daily medications Hospitalization in the neonatal intensive care unit (NICU) for longer than 2 months'}, 'identificationModule': {'nctId': 'NCT07468435', 'briefTitle': 'Effects of a Parenting Skills Training Program on Maternal Self-Efficacy, Perceived Social Support, and Infant Development in Mothers of Preterm Infants Aged 6-12 Months', 'organization': {'class': 'OTHER', 'fullName': 'Medipol University'}, 'officialTitle': 'Investigation of the Effects of a Parenting Skills Training Intervention Applied to Mothers of Preterm Infants Aged 6-12 Months on Maternal Parenting Self-Efficacy, Perceived Social Support, and Infant Developmental Level', 'orgStudyIdInfo': {'id': 'E-10840098-772.02-4699'}, 'secondaryIdInfos': [{'id': '557', 'type': 'OTHER', 'domain': 'Istanbul Medipol University Ethics Commitee'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Parental Training Group', 'description': 'Parental Training group will receive 7 session of training comprising communication ways with infant, bonding strategies, play and toy selection for development, sleep, feeding and social support.', 'interventionNames': ['Other: Parental Skill Training Program']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'This group will only receive assessment at baseline (T0), after study (T1) and follow-up (T3)'}], 'interventions': [{'name': 'Parental Skill Training Program', 'type': 'OTHER', 'description': "The intervention will consist of a structured Parenting Skills Training Program delivered to mothers of preterm infants aged 6-12 months (corrected age). The program will be designed as an individualized, home-based intervention aiming to strengthen maternal parenting skills, enhance parenting self-efficacy, and support infant development through responsive caregiving practices.\n\nMothers in the intervention group will receive the parenting skills training in multiple structured sessions delivered by a trained professional. Sessions will be conducted in the participants' homes and will include both informational and practical components tailored to the mother-infant dyad.", 'armGroupLabels': ['Parental Training Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34815', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Istanbul Medipol University', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'Minevver Emir, Msc', 'role': 'CONTACT', 'email': 'munevver.emir@medipol.edu.tr', 'phone': '+90 555-013-5120'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medipol University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Assistant', 'investigatorFullName': 'Münevver Emir', 'investigatorAffiliation': 'Medipol University'}}}}