Effects of a Parent-Mediated Self-Regulation Support Intervention in Preterm Infants

NCT07850297 | Completed DMC

• 1 other identifier: PRETERM-SR-01
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Preterm Birth Complication; Infant Self-regulation; Parenting Behavior

Keywords

preterm infant; self-regulation; parent-mediated intervention; early intervention; Parenting stress; Parental cooperation; Social support

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and immediately after the 12-week intervention

Secondary Outcomes (3)

• Change in Parenting Stress

  Baseline and immediately after the 12-week intervention

• Change in Perceived Social Support

  Baseline and immediately after the 12-week intervention

• Change in Parental Cooperation

  Baseline and immediately after the 12-week intervention

Study Arms (2)

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.

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.

Interventions

Parent-Mediated Self-Regulation Support Intervention BEHAVIORAL

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.

Parent-Mediated Self-Regulation Support Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Feryal Savcı: lead
• Ankara University: collaborator

Study Sites (1)

Istanbul Medipol University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Premature Birth; Self-Control

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Social Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 24, 2026
• First Posted: September 30, 2026
• Study Start: December 9, 2022
• Primary Completion: March 10, 2023
• Study Completion: April 14, 2023
• Last Updated: September 30, 2026

Record last verified: 2026-09

Locations

TU (1)