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临床试验/NCT07468435
NCT07468435尚未招募不适用

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

Medipol University1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2026年3月13日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
26
试验地点
1
主要终点
Preterm Parenting & Self-efficacy Checklist

研究概览

简要总结

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).

The main questions it aims to answer are:

Does a parenting skills training intervention improve maternal parenting self-efficacy?

Does the intervention increase mothers' perceived social support and positively influence infant developmental levels?

Researchers 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.

Participants will:

Complete baseline, post-intervention, and follow-up assessments of parenting self-efficacy and perceived social support

Have their infants assessed using standardized developmental evaluation tools

Participate in a structured, home-based parenting skills training program consisting of multiple sessions (intervention group only)

Take part in semi-structured interviews before and after the intervention to share their experiences and perceived needs

详细描述

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.

This 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.

The 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.

Primary 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.

By 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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

年龄范围
6 Months 至 12 Months(Child)
性别
All
接受健康志愿者

入选标准

  • 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
  • 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

排除标准

  • For Mothers Having any neurological, musculoskeletal and psychiatric diagnosis to effect the caregiving role
  • For Infants Use of multiple daily medications Hospitalization in the neonatal intensive care unit (NICU) for longer than 2 months

研究组 & 干预措施

Parental Training Group

Experimental

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.

干预措施: Parental Skill Training Program (Other)

Control Group

No Intervention

This group will only receive assessment at baseline (T0), after study (T1) and follow-up (T3)

结局指标

主要结局

Preterm Parenting & Self-efficacy Checklist

时间窗: Assessment will be completed at baseline, after the 7 week training program and end of the one month follow-up period

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. The 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. The 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

Multidimensional Scale of Perceived Social Support

时间窗: Assessment will be completed at baseline, after the 7 week training program and end of the one month follow-up period

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. The 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.

次要结局

  • Assessment of developmental level of children in five domains; gross motor, fine motor, communication, problem-solving, social skills.(Assessment will be completed at baseline, after the 7 week training program and end of the one month follow-up period)
  • Psychomotor, cognitive, language, and social-emotional developmental levels of infants.(Assessment will be completed at baseline, after the 7 week training program and end of the one month follow-up period)

研究者

发起方
Medipol University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Münevver Emir

Research Assistant

Medipol University

研究点 (1)

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