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

March 9, 2026 updated by: Münevver Emir, Medipol University

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Estimated)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Parental Training Group
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.
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 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.
No Intervention: Control Group
This group will only receive assessment at baseline (T0), after study (T1) and follow-up (T3)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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

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
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

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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

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.

The 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.
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

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.

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medipol University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 13, 2026

Primary Completion (Estimated)

June 20, 2026

Study Completion (Estimated)

August 30, 2026

Study Registration Dates

First Submitted

February 17, 2026

First Submitted That Met QC Criteria

March 9, 2026

First Posted (Actual)

March 12, 2026

Study Record Updates

Last Update Posted (Actual)

March 12, 2026

Last Update Submitted That Met QC Criteria

March 9, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E-10840098-772.02-4699
  • 557 (Other Identifier: Istanbul Medipol University Ethics Commitee)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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