PrematurityNCT07468435
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
A study testing Parental Skill Training Program in people with Prematurity, run by Medipol University at 1 site in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 6 to 12 monthsHealthy volunteers can take part
- Conditions the study is for
- Prematurity
- What is being tested?
- Parental Skill Training Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Mar 2026to 30 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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
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:
Read more
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
Read the 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
- Conditions
- Prematurity
- Being tested
- Parental Skill Training Program
- Keywords
- parental self-efficacy, social support, preterm infants, parenting skills
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parental Skill Training ProgramOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
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.
Measured: 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.
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.
Measured: Assessment will be completed at baseline, after the 7 week training program and end of the one month follow-up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start13 Mar 2026 (estimated)
- Primary completion20 Jun 2026 (estimated)
- Study completion30 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrematurityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Münevver Emir, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07468435
- Sponsor's protocol ID
- E-10840098-772.02-4699
- Other IDs
- 557
- Status last verified
- Feb 2026
- First submitted
- 17 Feb 2026
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07468435
- Acronym / sponsor ID
- E-10840098-772.02-4699
- Conditions
- Prematurity
- Keywords
- parental self-efficacy, social support, preterm infants, parenting skills
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 13 Mar 2026 (estimated)
- Primary completion
- 20 Jun 2026 (estimated)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 12 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parental Training Group | Experimental | Other: Parental Skill Training ProgramParental 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. |
| Control Group | No intervention | –This group will only receive assessment at baseline (T0), after study (T1) and follow-up (T3) |
Who may qualify
- Ages
- 6 to 12 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Parental Skill Training ProgramThe 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. | Other | Parental Training Group |
Primary outcome
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
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.
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parental Skill Training Program in people with Prematurity, run by Medipol University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Minevver Emir, Msc (+90 555-013-5120, munevver.emir@medipol.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2026.