Condition category
Mental and Behavioural Disorders
Date applied
29/05/2008
Date assigned
29/05/2008
Last edited
02/10/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Phyllis Zelkowitz

ORCID ID

Contact details

Departement de Psychiatrie
Hopital General Juif SMBD
4333 Chemin de la Cote Ste Catherine
Montreal
Quebec
H3T 1E4
Canada
+1 514 340 8222 ext. 5258
phyllis.zelkowitz@mcgill.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

MCT-79216

Study information

Scientific title

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

Acronym

Cues and Care Trial

Study hypothesis

Primary hypothesis:
The experimental group mothers will report lower levels of anxiety post-intervention compared to control group mothers.

Secondary hypotheses:
Compared to control group mothers, experimental group mothers will, in the immediate post-intervention period:
1. Have lower stress related to their infant's appearance and behaviour
2. Have lower stress related to their parental role restriction
3. Be more sensitive and responsive in interactions with their infant

At the 6-month follow-up:
4. Report less anxiety
5. Have lower perinatal post-traumatic stress
6. Exhibit greater sensitivity and responsivity in interactions with their infant

Ethics approval

Ethics approval received from the Research Ethics Committee of Sir Mortimer B. Davis Jewish General Hospital-Mtl (Hôpital Général Juif Sir Mortimer B. Davis) on the 31st March 2006 (ref: CRO6-19).

Study design

Multicentre, two arm, randomised parallel trial with outcome assessor blinding.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Anxiety in mothers of very low birthweight infants

Intervention

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 experimental intervention will be delivered over a six to eight week period.

Attention control group:
Provision of general information on infant care, six sessions with an intervener, each lasting 60 - 90 minutes, for a total dose of 9 - 10 hours. The control intervention will be delivered over a six to eight week period.

Contact for public queries:
Jenifer Chappell
Project Coordinator
Tel: +1 514 340 8222 ext. 3267
Email: jenifer.chappell@gmail.com

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

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

Secondary outcome measures

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

Overall trial start date

01/05/2006

Overall trial end date

30/09/2009

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

92

Participant 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)

Recruitment start date

01/05/2006

Recruitment end date

30/09/2009

Locations

Countries of recruitment

Canada

Trial participating centre

Departement de Psychiatrie
Montreal, Quebec
H3T 1E4
Canada

Sponsor information

Organisation

Sir Mortimer B. Davis Jewish General Hospital (Hôpital Général Juif Sir Mortimer B. Davis) (Canada)

Sponsor details

3755 Côte Ste-Catherine Road
Montreal
Quebec
H3T 1E2
Canada
+1 514 340 8222
razoulay@jgh.mcgill.ca

Sponsor type

Hospital/treatment centre

Website

http://www.jgh.ca

Funders

Funder type

Research organisation

Funder name

Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-79216)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2008 study protocol in http://www.ncbi.nlm.nih.gov/pubmed/18822128

Publication citations

  1. Study protocol

    Zelkowitz P, Feeley N, Shrier I, Stremler R, Westreich R, Dunkley D, Steele R, Rosberger Z, Lefebvre F, Papageorgiou A, 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., BMC Pediatr, 2008, 8, 38, doi: 10.1186/1471-2431-8-38.

Additional files

Editorial Notes