Pilot RCT of the use of VIG with preterm babies

Using video interaction to support parents whose babies were born at 32 weeks or less gestation: Results of a Pilot RCT

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN49732312

Enrollment

Registered

2014-10-23

Start date

2012-01-01

Completion date

Unknown

Last updated

2017-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Improving parental sensitivity with their preterm babies Pregnancy and Childbirth

Interventions

Both the intervention and control groups received usual care from community health staff. The intervention group received an additional 3 home visits from a practitioner trained in VIG. The VIG practi

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Parents with an infant born at 32 weeks or less gestation, who had received care on the neonatal unit (NICU).

Exclusion criteria

Exclusion criteria: Parents with twins or multiple births

Design outcomes

Primary

Measure	Time frame
Parent-infant interaction which was measured using a three-minute videoclip of parent-infant interaction that was coded using the CARE-Index. 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.	—

Measure

Time frame

Parent-infant interaction which was measured using a three-minute videoclip of parent-infant interaction that was coded using the CARE-Index. 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.

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Secondary

Measure	Time frame
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. 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. 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	—

Measure

Time frame

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. 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. 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

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Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026