NCT07468435

Brief Summary

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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
3mo left

Started Mar 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress56%
Mar 2026Aug 2026

First Submitted

Initial submission to the registry

February 17, 2026

Completed
23 days until next milestone

First Posted

Study publicly available on registry

March 12, 2026

Completed
1 day until next milestone

Study Start

First participant enrolled

March 13, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2026

Last Updated

March 12, 2026

Status Verified

February 1, 2026

Enrollment Period

3 months

First QC Date

February 17, 2026

Last Update Submit

March 9, 2026

Conditions

Keywords

parental self-efficacysocial supportpreterm infantsparenting skills

Outcome Measures

Primary Outcomes (2)

  • Preterm Parenting & Self-efficacy Checklist

    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

    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 Outcomes (2)

  • 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

Study Arms (2)

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.

Other: Parental Skill Training Program

Control Group

NO INTERVENTION

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

Interventions

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.

Parental Training Group

Eligibility Criteria

Age6 Months - 12 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Medipol University

Istanbul, 34815, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

February 17, 2026

First Posted

March 12, 2026

Study Start

March 13, 2026

Primary Completion (Estimated)

June 20, 2026

Study Completion (Estimated)

August 30, 2026

Last Updated

March 12, 2026

Record last verified: 2026-02

Locations