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

ISRCTN ISRCTN00918472
DOI https://doi.org/10.1186/ISRCTN00918472
Secondary identifying numbers MCT-79216
Submission date
29/05/2008
Registration date
29/05/2008
Last edited
06/11/2019
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Phyllis Zelkowitz
Scientific

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

Study information

Study designMulticentre, two arm, randomised parallel trial with outcome assessor blinding.
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleA trial of a skills-based intervention to reduce maternal anxiety and improve developmental outcomes in very low birthweight infants
Study acronymCues and Care Trial
Study objectivesPrimary 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(s)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).
Health condition(s) or problem(s) studiedAnxiety in mothers of very low birthweight infants
InterventionExperimental 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 typeOther
Primary outcome measureMaternal state anxiety, immediately post-intervention at infant corrected age of 1 - 1.5 months.
Secondary outcome measures1. 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 study start date01/05/2006
Completion date30/09/2009

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participants92
Key inclusion criteria1. 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
Key exclusion criteria1. 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)
Date of first enrolment01/05/2006
Date of final enrolment30/09/2009

Locations

Countries of recruitment

  • Canada

Study participating centre

Departement de Psychiatrie
Montreal, Quebec
H3T 1E4
Canada

Sponsor information

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

3755 Côte Ste-Catherine Road
Montreal, Quebec
H3T 1E2
Canada

+1 514 340 8222
razoulay@jgh.mcgill.ca
http://www.jgh.ca
ROR logo https://ror.org/056jjra10

Funders

Funder type

Research organisation

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article study protocol 26/09/2008 Yes No

Editorial Notes

06/11/2019: Internal review.

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