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Not yet recruiting NCT07468435

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

No phase Interventional Prematurity

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Parental Skill Training Program.
Who it may be relevant to
Registry conditions: Prematurity. Basic parameters: 6 months — 12 months · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

Detailed description

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

Interventions

  • Other Parental Skill Training Program
    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. Mothers in the intervention group will receive the parenting skills training in multiple structured sessions delivere

Primary outcome measures

  • Preterm Parenting & Self-efficacy Checklist [Time frame: Assessment will be completed at baseline, after the 7 week training program and end of the one month follow-up period]
  • Multidimensional Scale of Perceived Social Support [Time frame: Assessment will be completed at baseline, after the 7 week training program and end of the one month follow-up period]
Secondary outcome measures (2)
  • Assessment of developmental level of children in five domains; gross motor, fine motor, communication, problem-solving, social skills. [Time frame: 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. [Time frame: Assessment will be completed at baseline, after the 7 week training program and end of the one month follow-up period]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Supportive care

Study locations

Turkey (Türkiye) · 1 center
  • Istanbul Medipol University — Istanbul

Identifiers

NCT: NCT07468435 · E-10840098-772.02-4699 · 557

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗