Condition category
Mental and Behavioural Disorders
Date applied
11/07/2009
Date assigned
14/07/2009
Last edited
16/11/2015
Prospective/Retrospective
Prospectively 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 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

http://www.ubc.ca/

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

Publication citations

Additional files

Editorial Notes