A randomised control trial (RCT) of enhanced parenting to improve developmental outcomes in preterm infants.

Not Applicable

Recruiting

• Conditions: Prematurity; Public Health - Health promotion/education; Reproductive Health and Childbirth - Complications of newborn

• Registration Number: ACTRN12612000194864
• Lead Sponsor: Prof Paul Colditz

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02-15
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 330

Inclusion Criteria

Preterm infant born <32 weeks Parents must agree to assessment requirements of the study Parents must be english speaking

Exclusion Criteria

Infants: Born > 32 weeks, major congenital abnormalities Parents: No English spoken, do not agree to the assessment requirements of the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
A clinically important difference in child behavioural and emotional problems to be a standardised effect size of 0.33 on the ITSEA (A 92-item parent-report questionnaire to assess social-emotional problems/competencies in domains: behavioural dysregulation; externalising behaviour; internalising behaviour).[ 12 months ca, 24 months ca];A 15-minute observation of mother-child interaction will be recorded and coded for child behavioural and emotional problems using the Family Observation Schedule Revised (FOS).[ 6 weeks ca, 12 months ca, 24 months ca]