Contact information
Type
Scientific
Primary contact
Dr Wendy Hall
ORCID ID
Contact details
T. 201 2211 Wesbrook Mall
School of Nursing
University of British Columbia
Vancouver
V6T 2B5
Canada
+1 (0)604 822 7447
Wendy.hall@nursing.ubc.ca
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00877162
Protocol/serial number
MCT-94836
Study information
Scientific title
Night waking reduction in Canadian infants: a randomised controlled trial of a parent-based cognitive and behavioural intervention in community health units
Acronym
Study hypothesis
In a population of parents who have infants with behavioural sleep problems, are parents randomised to a cognitive-behavioural sleep intervention compared to parents randomised to a group cognitive-behavioural safety intervention more or less likely to:
1. Identify their child as having a severe sleep problem, or
2. To have their child wake fewer than an average of two times per night over five nights by actigraphy?
Ethics approval
University of British Columbia Behavioural Ethics Review Board, 23/06/2009, ref: H09-00757
Study design
Randomised single-centre controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Behavioural sleep problems
Intervention
Current interventions as of 16/05/2013 (this change was due to an error in the original application):
Following randomisation, both groups receive a two hour teaching session delivered to both parents in two parent families or one parent in single-parent families and telephone calls. Five groups of parents at each health unit (5 units) attend two hour teaching sessions (either sleep-based or safety-based). Two telephone calls per week for two weeks support the parent leading the intervention by focusing on reinforcing the knowledge and skills obtained from the two-hour teaching session. After the six-week data collection point, the sleep group receives a pamphlet on managing infant safety and the safety group receives a pamphlet about managing infant sleep problems.
Experimental Group:
The teaching session for the intervention group and the follow-up phone calls, which were developed by Hall for the pilot study, will be delivered by PHNs who have been trained by the research team. This intervention aims to change parents' cognitions about areas, such as normal infant sleep, effects of inadequate sleep for infants and parents, setting limits around infant sleep, feeding infants to sleep, and infant sleep safety. It introduces behaviours parents can use to promote sleep self-initiation in infants. Parents receive instructions for completing charts so they can track their use of routines and controlled comforting and changes in infant sleep and settling. A videotaped recording of an infant in light and deep sleep, and a videotaped recording of an interview with parents about living with their infant's sleep problem will be shown. The session ends with a question and answer period. Parent handouts include: a paper copy of the scripted Power Point presentation, five copies of the weekly sleep-wake-feed charts and 10 copies of the controlled crying/comforting charts. To reinforce information and provide support for the parent leading the intervention, PHNs will make two telephone calls per week for two weeks. The calls will include questions to determine how best to provide support:
1. How are parents managing?
2. Which strategies are they using to deal with the sleep problem?
3. What are the effects of those strategies on the infant and parents?
4. What, if any, difficulties are they experiencing?
PHNs will also provide a check list of points and standard responses to requests by family members for assistance beyond the sleep intervention.
Control Group:
The safety teaching session for the control group and the follow-up phone calls to support the parent leading the intervention are undertaken by research team members. Safety is the topic, because shaken baby syndrome is a possibility, if parents become angry about constant sleep disruptions. The session includes content about shaken baby syndrome, choking prevention, fall prevention, sleep positioning, hazards of infant walkers, motor vehicle safety, pacifier safety, toy safety, and suffocation, strangulation, drowning, animal bite, poisoning, and burn prevention. Co-sleeping as a risk to infant safety is not discussed. The safety teaching session is scripted using a Power Point CD. Parents will receive a paper handout. Two telephone calls per week for two weeks using the same questions as the intervention group support the lead parent's efforts to use safety strategies. The calls will include the following questions:
1. How are the parents managing?
2. Which strategies are they using to deal with the safety problem?
3. What are the effects of those strategies on the infants and parents?
Registered nurses will also provide a checklist of points and standard responses to requests by family members for assistance beyond the safety intervention.
The total duration of treatment is three weeks (one two-hour teaching session, and two weeks of twice weekly follow-up telephone calls. The total duration of follow-up is 24 weeks post-teaching session.
Previous interventions until 16/05/2013:
Following randomisation, both groups receive a two hour teaching session delivered to both parents in two parent families or one parent in single-parent families and telephone calls. Five groups of parents at each health unit (5 units) attend two hour teaching sessions (either sleep-based or safety-based). Two telephone calls per week for two weeks support the parent leading the intervention by focusing on reinforcing the knowledge and skills obtained from the two-hour teaching session. After the six-week data collection point, the sleep group receives a pamphlet on managing infant safety and the safety group receives a pamphlet about managing infant sleep problems.
Experimental Group:
The teaching session for the intervention group and the follow-up phone calls, which were developed by Hall for the pilot study, will be delivered by PHNs who have been trained by the research team. This intervention aims to change parents' cognitions about areas, such as normal infant sleep, effects of inadequate sleep for infants and parents, setting limits around infant sleep, feeding infants to sleep, and infant sleep safety. It introduces behaviours parents can use to promote sleep self-initiation in infants. Parents receive instructions for completing charts so they can track their use of routines and controlled comforting and changes in infant sleep and settling. A videotaped recording of an infant in light and deep sleep, and a videotaped recording of an interview with parents about living with their infant's sleep problem will be shown. The session ends with a question and answer period. Parent handouts include: a paper copy of the scripted Power Point presentation, five copies of the weekly sleep-wake-feed charts and 10 copies of the controlled crying/comforting charts. To reinforce information and provide support for the parent leading the intervention, PHNs will make two telephone calls per week for two weeks. The calls will include questions to determine how best to provide support:
1. How are parents managing?
2. Which strategies are they using to deal with the sleep problem?
3. What are the effects of those strategies on the infant and parents?
4. What, if any, difficulties are they experiencing?
PHNs will also provide a check list of points and standard responses to requests by family members for assistance beyond the sleep intervention.
Control Group:
The safety teaching session for the control group and the follow-up phone calls to support the parent leading the intervention are undertaken by research team members. Safety is the topic, because shaken baby syndrome is a possibility, if parents become angry about constant sleep disruptions. The session includes content about shaken baby syndrome, choking prevention, fall prevention, sleep positioning, hazards of infant walkers, motor vehicle safety, pacifier safety, toy safety, and suffocation, strangulation, drowning, animal bite, poisoning, and burn prevention. Co-sleeping as a risk to infant safety is not discussed. The safety teaching session is scripted using a Power Point CD. Parents will receive a paper handout. Two telephone calls per week for two weeks using the same questions as the intervention group support the lead parent's efforts to use safety strategies. The calls will include the following questions:
1. How are parents managing?
2. Which strategies are they using to deal with the sleep problem?
3. What are the effects of those strategies on the infant and parents?
4. What, if any, difficulties are they experiencing?
PHNs will also provide a check list of points and standard responses to requests by family members for assistance beyond the sleep intervention.
The total duration of treatment is three weeks (one two-hour teaching session, and two weeks of twice weekly follow-up telephone calls. The total duration of follow-up is 24 weeks post-teaching session.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Significant infant sleep disturbance as measured with a composite measure, consisting of either the parent reporting a severe sleep problem, using the four-point sleep problem severity measure (no problem to severe problem), or mean actigraphic wakes of greater than two per night averaged over five nights at six weeks post-teaching session. These measures will be obtained at baseline, 6 weeks post-teaching session and 24 weeks post-teaching session.
Secondary outcome measures
Measured at 6 and 24 weeks post-teaching session:
1. Infants' averaged mean wakes over five nights by actigraphy
2. Parents' perceptions of sleep problems (using the four-point sleep problem severity measure)
3. Fatigue (using the Multidimensional Assessment of Fatigue Scale)
4. Depressed mood (using the Centre for Epidemiologic Studies Depression Measure)
5. Duration of infants' longest sleep periods (by actigraphy)
6. Parents quality of sleep (using the Pittsburgh Sleep Quality Index)
7. Quality of parental cognitions about infant sleep (using the Maternal Cognitions about Infant Sleep Questionnaire)
8. Costs for the intervention compared to the costs of parents using other sources of help (using resources consumed and unit prices for resources, including intervention costs)
Overall trial start date
01/09/2009
Overall trial end date
01/12/2011
Reason abandoned
Eligibility
Participant inclusion criteria
Infants:
1. Have no identified health problems
2. Between corrected ages of 5.5 and 8 months, either sex
3. Meet the American Academy of Sleep Medicine (AASM) sleep problem criteria (waking two or more times per night and/or waking lasting more than 20 minutes, occurring at least four nights per week for a minimum of three weeks)
Parents:
1. Biological or adoptive
2. Can read and speak English
3. Have access to a telephone
4. Are in single parent families or two parent families with both parents committing to the study
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
720 participants (240 families with infant, mother and father)
Participant exclusion criteria
Infants:
1. Organic causes of sleep disruption
2. Developmental disability
3. Chronic neurological or respiratory conditions
Parents:
1. Diagnosed depression
2. Diagnosed sleep problems
3. Permanent night shift work
Recruitment start date
01/09/2009
Recruitment end date
01/12/2011
Locations
Countries of recruitment
Canada
Trial participating centre
T. 201 2211 Wesbrook Mall
Vancouver
V6T 2B5
Canada
Sponsor information
Organisation
University of British Columbia (Canada)
Sponsor details
Office of Research Services
TEF III #102
6190 Agronomy Road
Vancouver
BC
V6T 1Z3
Canada
Sponsor type
University/education
Website
Funders
Funder type
Research organisation
Funder name
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-94836)
Alternative name(s)
Instituts de Recherche en Santé du Canada, CIHR
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
Canada
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
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26567090