Study protocol

The Cues and Care Trial: A randomized controlled trial of an intervention to reduce maternal anxiety and improve developmental outcomes in very low birthweight infants

Phyllis Zelkowitz^1,2 , Nancy Feeley^3,4 , Ian Shrier^5,2 , Robyn Stremler⁶ , Ruta Westreich^1,2 , David Dunkley^1,2 , Russell Steele⁷ , Zeev Rosberger^1,2 , Francine Lefebvre^8,9 and Apostolos Papageorgiou^10,2

¹Department of Psychiatry, SMBD-Jewish General Hospital, Montreal, Canada

²McGill University, Montreal, Canada

³Centre for Nursing Research, SMBD-Jewish General Hospital, Montreal, Canada

⁴School of Nursing, McGill University, Montreal, Canada

⁵Department of Epidemiology, SMBD-Jewish General Hospital, Montreal, Canada

⁶Lawrence S. Bloomberg Faculty of Nursing, University of Toronto, Toronto, Canada

⁷Department of Mathematics and Statistics, McGill University, Montreal, Canada

⁸Department of Neonatology, Hôpital Ste-Justine, Montreal, Canada

⁹Université de Montréal, Montreal, Canada

¹⁰Department of Neonatology, SMBD-Jewish General Hospital, Montreal, Canada

author email corresponding author email

BMC Pediatrics 2008, 8:38doi:10.1186/1471-2431-8-38

Published:	26 September 2008

Abstract

Background

Very low birthweight infants are at risk for deficits in cognitive and language development, as well as attention and behaviour problems. Maternal sensitive behaviour (i.e. awareness of infant cues and appropriate responsiveness to those cues) in interaction with her very low birthweight infant is associated with better outcomes in these domains; however, maternal anxiety interferes with the mother's ability to interact sensitively with her very low birthweight infant. There is a need for brief, cost-effective and timely interventions that address both maternal psychological distress and interactive behaviour. The Cues and Care trial is a randomized controlled trial of an intervention designed to reduce maternal anxiety and promote sensitive interaction in mothers of very low birthweight infants.

Methods and design

Mothers of singleton infants born at weights below 1500 g are recruited in the neonatal intensive care units of 2 tertiary care hospitals, and are randomly assigned to the experimental (Cues) intervention or to an attention control (Care) condition. The Cues intervention teaches mothers to attend to their own physiological, cognitive, and emotional cues that signal anxiety and worry, and to use cognitive-behavioural strategies to reduce distress. Mothers are also taught to understand infant cues and to respond sensitively to those cues. Mothers in the Care group receive general information about infant care. Both groups have 6 contacts with a trained intervener; 5 of the 6 sessions take place during the infant's hospitalization, and the sixth contact occurs after discharge, in the participant mother's home. The primary outcome is maternal symptoms of anxiety, assessed via self-report questionnaire immediately post-intervention. Secondary outcomes include maternal sensitive behaviour, maternal symptoms of posttraumatic stress, and infant development at 6 months corrected age.

Discussion

The Cues and Care trial will provide important information on the efficacy of a brief, skills-based intervention to reduce anxiety and increase sensitivity in mothers of very low birthweight infants. A brief intervention of this nature may be more readily implemented as part of standard neonatal intensive care than broad-based, multi-component interventions. By intervening early, we aim to optimize developmental outcomes in these high risk infants.

Trial Registration

Current Controlled Trials ISRCTN00918472

The Cues and Care Trial: A randomized controlled trial of an intervention to reduce maternal anxiety and improve developmental outcomes in very low birthweight infants