Preterm Birth ComplicationNCT07850297
Effects of a Parent-Mediated Self-Regulation Support Intervention in Preterm Infants
A study testing Parent-Mediated Self-Regulation Support Intervention in people with Preterm Birth Complication and Infant Self-regulation, run by Feryal Savcı at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to evaluate the effects of a parent-mediated self-regulation support intervention on self-regulation skills in preterm infants and on parenting stress, perceived social support, and parental cooperation. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Preterm Birth Complication, Infant Self-regulation, Parenting Behavior
- What is being tested?
- Parent-Mediated Self-Regulation Support Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 Dec 2022to 14 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- • Born preterm between 32 and 36 completed weeks of gestation (32+0 to 36+6 weeks), representing moderate and late preterm birth.
- Corrected age between 12 and 18 months at enrollment.
- No diagnosed developmental, neurological, or congenital disorder that could substantially affect developmental functioning.
- Living with and receiving regular care from the participating parent(s).
Who cannot join
- Being the mother or father of an eligible preterm infant participating in the study.
- Providing regular care for the infant.
- Being able to understand and communicate in Turkish.
- Voluntarily agreeing to participate in the study and providing informed consent.
- For parents in the intervention group, agreeing to participate in the intervention program and study assessments.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of a Parent-Mediated Self-Regulation Support Intervention on Self-Regulation Skills of Preterm Infants, Parenting Stress, Perceived Social Support, and Parental Cooperation
This study aimed to evaluate the effects of a parent-mediated self-regulation support intervention on self-regulation skills in preterm infants and on parenting stress, perceived social support, and parental cooperation. Preterm infants with a corrected age of 12-18 months and their parents were assigned to intervention and control groups. The intervention group participated in a 12-week parent-mediated self-regulation support program, including weekly training sessions and three home visits. Outcomes were assessed at baseline and immediately after the intervention, with a follow-up assessment conducted four weeks after the intervention in the intervention group.
Read the detailed description
This study used an experimental pretest-posttest control-group design embedded within a mixed-methods framework. The study included preterm infants with a corrected age of 12-18 months and their parents. Following baseline assessments, participants were allocated to intervention and control groups using a matching procedure.
Parents in the intervention group participated in a 12-week parent-mediated self-regulation support intervention delivered once weekly. In addition to the training sessions, three home visits were conducted, approximately once per month, to support the implementation of intervention strategies in the home environment. The control group did not receive the self-regulation support intervention during the study period.
Quantitative assessments examined infant self-regulation skills, parenting stress, perceived social support, and parental cooperation. Measurements were conducted at baseline and immediately after completion of the intervention. A follow-up assessment was conducted four weeks after the intervention in the intervention group to examine the maintenance of intervention effects. Qualitative data were also collected as part of the concurrent embedded mixed-methods design.
- Being tested
- Parent-Mediated Self-Regulation Support Intervention
- Keywords
- preterm infant, self-regulation, parent-mediated intervention, early intervention, Parenting stress, Parental cooperation, Social support
- Medical subject headings
- Premature Birth, Self-Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parent-Mediated Self-Regulation Support InterventionBehavioural
The Parent-Mediated Self-Regulation Support Intervention was a 12-week developmental program for parents of preterm infants aged 12-18 months corrected age. It aimed to enhance parents' ability to recognize and respond to infant regulatory cues and support cognitive, emotional, and behavioral self-regulation through responsive parent-infant interactions. The program included weekly parent training sessions and three monthly home visits. Parents were encouraged to apply the strategies during daily routines. Key components included recognizing infant cues, responsive caregiving, emotional regulation, attention and engagement, and adaptive behavioral regulation.
| Study group | Role | What they receive |
|---|---|---|
| Parent-Mediated Self-Regulation Support Intervention | Experimental | Parents of preterm infants in the intervention group participated in a 12-week parent-mediated self-regulation support program designed to promote infants' self-regulation skills through developmentally appropriate parent-infant interactions and caregiving practices. The intervention consisted of weekly parent training sessions and three home visits conducted during the intervention period. Receives: Behavioral: Parent-Mediated Self-Regulation Support Intervention |
| Control Group | No intervention | Participants in the control group did not receive the parent-mediated self-regulation support intervention during the study period and continued their usual care and daily routines. They underwent the same baseline and post-intervention quantitative assessments as the intervention group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Infant Self-Regulation Skills
Infant self-regulation skills were assessed using the Infant Self-Regulation Skills Scale, a 29-item parent-report measure comprising cognitive, emotional, and behavioral self-regulation dimensions. Items are rated on a 5-point Likert-type scale. Higher scores indicate higher levels of self-regulation skills.
Measured: Baseline and immediately after the 12-week intervention
Secondary outcomes (3)
Change in Parenting Stress
Parenting stress was assessed using The Parental Stress Scale. The scale evaluates parents' perceived stress associated with the parenting role. Higher scores indicate [higher/lower] levels of parenting stress.
Measured: Baseline and immediately after the 12-week intervention
Change in Perceived Social Support
Perceived social support was assessed using Renewed Parent Social Support Scale. The instrument assesses parents' perceived availability and adequacy of social support. Higher scores indicate [higher/lower] perceived social support.
Measured: Baseline and immediately after the 12-week intervention
Change in Parental Cooperation
Parental cooperation was assessed using The Parental Cooperation Inventory. The instrument evaluates cooperation between parents in relation to parenting and child-rearing processes. Higher scores indicate [higher/lower] levels of parental cooperation.
Measured: Baseline and immediately after the 12-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2026
- Study start9 Dec 2022
- Primary completion10 Mar 2023
- Study completion14 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm Birth ComplicationStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Feryal Savcı
- Sponsor type
- University, hospital or other
- Collaborators
- Ankara University
- Responsible party
- Sponsor-investigator, Feryal Savcı, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07850297
- Sponsor's protocol ID
- PRETERM-SR-01
- Status last verified
- Sep 2026
- First submitted
- 24 Sep 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It can be provided upon request.
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Parent-Mediated Self-Regulation Support Intervention on Self-Regulation Skills of Preterm Infants, Parenting Stress, Perceived Social Support, and Parental Cooperation
- ClinicalTrials.gov ID
- NCT07850297
- Acronym / sponsor ID
- PRETERM-SR-01
- Keywords
- preterm infant, self-regulation, parent-mediated intervention, early intervention, Parenting stress, Parental cooperation, Social support
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Feryal SavcıUniversity, hospital or other
- Collaborators
- Ankara University
- Study start
- 9 Dec 2022 (actual)
- Primary completion
- 10 Mar 2023 (actual)
- Study completion
- 14 Apr 2023 (actual)
- First posted
- 30 Sep 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.
This study aimed to evaluate the effects of a parent-mediated self-regulation support intervention on self-regulation skills in preterm infants and on parenting stress, perceived social support, and parental cooperation. Preterm infants with a corrected age of 12-18 months and their parents were assigned to intervention and control groups. The intervention group participated in a 12-week parent-mediated self-regulation support program, including weekly training sessions and three home visits. Outcomes were assessed at baseline and immediately after the intervention, with a follow-up assessment conducted four weeks after the intervention in the intervention group.
Detailed description
This study used an experimental pretest-posttest control-group design embedded within a mixed-methods framework. The study included preterm infants with a corrected age of 12-18 months and their parents. Following baseline assessments, participants were allocated to intervention and control groups using a matching procedure.
Parents in the intervention group participated in a 12-week parent-mediated self-regulation support intervention delivered once weekly. In addition to the training sessions, three home visits were conducted, approximately once per month, to support the implementation of intervention strategies in the home environment. The control group did not receive the self-regulation support intervention during the study period.
Quantitative assessments examined infant self-regulation skills, parenting stress, perceived social support, and parental cooperation. Measurements were conducted at baseline and immediately after completion of the intervention. A follow-up assessment was conducted four weeks after the intervention in the intervention group to examine the maintenance of intervention effects. Qualitative data were also collected as part of the concurrent embedded mixed-methods design.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parent-Mediated Self-Regulation Support Intervention | Experimental | Behavioral: Parent-Mediated Self-Regulation Support InterventionParents of preterm infants in the intervention group participated in a 12-week parent-mediated self-regulation support program designed to promote infants' self-regulation skills through developmentally appropriate parent-infant interactions and caregiving practices. The intervention consisted of weekly parent training sessions and three home visits conducted during the intervention period. |
| Control Group | No intervention | –Participants in the control group did not receive the parent-mediated self-regulation support intervention during the study period and continued their usual care and daily routines. They underwent the same baseline and post-intervention quantitative assessments as the intervention group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- • Born preterm between 32 and 36 completed weeks of gestation (32+0 to 36+6 weeks), representing moderate and late preterm birth.
Key exclusion criteria (5 listed)
- Being the mother or father of an eligible preterm infant participating in the study.
- Providing regular care for the infant.
- Being able to understand and communicate in Turkish.
- Voluntarily agreeing to participate in the study and providing informed consent.
- For parents in the intervention group, agreeing to participate in the intervention program and study assessments.
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 |
|---|---|---|
| Parent-Mediated Self-Regulation Support InterventionThe Parent-Mediated Self-Regulation Support Intervention was a 12-week developmental program for parents of preterm infants aged 12-18 months corrected age. It aimed to enhance parents' ability to recognize and respond to infant regulatory cues and support cognitive, emotional, and behavioral self-regulation through responsive parent-infant interactions. The program included weekly parent training sessions and three monthly home visits. Parents were encouraged to apply the strategies during daily routines. Key components included recognizing infant cues, responsive caregiving, emotional regulation, attention and engagement, and adaptive behavioral regulation. | Behavioural | Parent-Mediated Self-Regulation Support Intervention |
Primary outcome
Change in Infant Self-Regulation Skills
Time frame: Baseline and immediately after the 12-week intervention
Infant self-regulation skills were assessed using the Infant Self-Regulation Skills Scale, a 29-item parent-report measure comprising cognitive, emotional, and behavioral self-regulation dimensions. Items are rated on a 5-point Likert-type scale. Higher scores indicate higher levels of self-regulation skills.
3 secondary outcomes
Change in Parenting Stress
Time frame: Baseline and immediately after the 12-week intervention
Change in Perceived Social Support
Time frame: Baseline and immediately after the 12-week intervention
Change in Parental Cooperation
Time frame: Baseline and immediately after the 12-week intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: Undecided. It can be provided upon request.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parent-Mediated Self-Regulation Support Intervention in people with Preterm Birth Complication and Infant Self-regulation, run by Feryal Savcı 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 30 Sep 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Infant Self-Regulation Skills (time frame: Baseline and immediately after the 12-week intervention). 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 30 Sep 2026.