Pilot RCT of the use of VIG with preterm babies
Not Applicable
Completed
- Conditions
- Improving parental sensitivity with their preterm babiesPregnancy and Childbirth
- Registration Number
- ISRCTN49732312
- Lead Sponsor
- niversity of Warwick (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 78
Inclusion Criteria
Parents with an infant born at 32 weeks or less gestation, who had received care on the neonatal unit (NICU).
Exclusion Criteria
Parents with twins or multiple births
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Parent-infant interaction which was measured using a three-minute videoclip of parent-infant interaction that was coded using the CARE-Index.<br><br>This measure classifies infant and adult interaction on seven dimensions - three aspects of maternal behaviour (sensitivity; covert and overt hostility; unresponsiveness) and four aspects of infant behaviour (co-operation; compulsivity ; difficultness; and passivity). This scale is highly correlated with the infant Strange Situation assessment pattern of attachment. Scores range from 0 to 14, higher scores indicating better sensitivity and/or co-operation. Inter-rater reliability for the current study was 0.77 for Sensitivity and 0.81 for Co-operation for two coders who were blind to study group.
- Secondary Outcome Measures
Name Time Method 1. The Hospital Anxiety and Depression Scale - this is a 14-item validated self-rating scale that measures anxiety and depression in both hospital and community settings. Lower scores indicate improvement.<br>2. The Parenting Stress Inventory - this is a validated measure of both sources and levels of stress in parents of a new baby, and comprises a 23-item Likert scale with lower scores indicating less stress.<br>3. The Primary Care - Post Traumatic Stress Disorder - this is a 4-item screen that was designed for use in primary care and other medical settings. The screen includes an introductory sentence to cue respondents to traumatic events, and a positive response to 3 items indicates the need for further assessment with a structured interview for PTSD