Cues and Care: A trial of an intervention to promote mothers' ability to communicate with their very low birthweight infants

A trial of a skills-based intervention to reduce maternal anxiety and improve developmental outcomes in very low birthweight infants

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN00918472

Enrollment

Registered

2008-05-29

Start date

2006-05-01

Completion date

Unknown

Last updated

2019-12-10

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

Conditions

Anxiety in mothers of very low birthweight infants Mental and Behavioural Disorders Other anxiety disorders

Interventions

Experimental group: Anxiety reduction techniques and sensitivity training, six sessions with an intervener, each lasting 60 - 90 minutes, for a total dose of 9 - 10 hours. The experime

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Infant birthweight less than 1500g 2. Mother can speak and read either English or French 3. Mother able to sign informed consent form 4. Family resides withing a 90 minute drive of participating hospitals

Exclusion criteria

Exclusion criteria: 1. Mother will not be caring for the infant after discharge (e.g. due to foster placement or adoption) 2. Infant is in a highly unstable medical condition that is likely to result in death, has a major congenital anomaly, or is known to have a major sensory handicap (e.g. blindness) 3. Infant is likely to be transferred or discharged in less than four weeks 4. Multiple birth (twins, triplets)

Design outcomes

Primary

Measure	Time frame
Maternal state anxiety, immediately post-intervention at infant corrected age of 1 - 1.5 months.	—

Secondary

Measure	Time frame
1. Stress related to infant's appearance and behaviour in the Neonatal Intensive Care Unit (NICU), immediately post-intervention at infant corrected age of 1 - 1.5 months 2. Stress related to maternal role restriction, immediately post-intervention at infant corrected age of 1 - 1.5 months 3. Sensitivity of maternal behaviour, immediately post-intervention at infant corrected ages of 1 - 1.5 months and 6 months 4. Perinatal post-traumatic stress, immediately post-intervention at infant corrected ages of 1 - 1.5 months and 6 months 5. Postpartum depression, infant corrected age of 1 - 1.5 months and at 6 months corrected age 6. Infant cognitive and motor development, when the infant is of 6 months corrected age	—

Measure

Time frame

1. Stress related to infant's appearance and behaviour in the Neonatal Intensive Care Unit (NICU), immediately post-intervention at infant corrected age of 1 - 1.5 months 2. Stress related to maternal role restriction, immediately post-intervention at infant corrected age of 1 - 1.5 months 3. Sensitivity of maternal behaviour, immediately post-intervention at infant corrected ages of 1 - 1.5 months and 6 months 4. Perinatal post-traumatic stress, immediately post-intervention at infant corrected ages of 1 - 1.5 months and 6 months 5. Postpartum depression, infant corrected age of 1 - 1.5 months and at 6 months corrected age 6. Infant cognitive and motor development, when the infant is of 6 months corrected age

—

Countries

Canada

Outcome results

None listed

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