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
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.