Condition category
Mental and Behavioural Disorders
Date applied
09/08/2005
Date assigned
09/08/2005
Last edited
09/07/2013
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 Graham James Reid

ORCID ID

Contact details

Social Sciences Centre
1151 Richmond Street
SSC 7310
University of Western Ontario
London
Ontario
N6A 5C2
Canada
+1 519 661 2111 (84677)
greid@uwo.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00133055

Protocol/serial number

MCT-67816

Study information

Scientific title

Acronym

Study hypothesis

We hypothesise that parents receiving treatment booklets addressing sleep and bedtime behaviours (Trial 1) or discipline problems (Trial 2) and telephone support, along with usual care by their family physician, will demonstrate greater reductions in sleep or discipline problems, improved parenting practices, and greater reductions in child behaviour problems in general following the intervention compared to parents receiving usual medical care.

Ethics approval

The University of Western Ontario Research Ethics Board for Health Sciences Research Involving Human Subjects (HSREB), 08/11/2004

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Discipline and Sleep Problems

Intervention

Intervention group in each trial (trial 1 - [sleep], trial 2 [discipline] and trial 3 [both sleep and discipline]) will receive by mail a problem-specific self-help treatment booklet. Trial 3 participants will receive one of the two treatment booklets. Furthermore all of them will receive telephone support (three phone calls in total over six week treatment period) in addition to usual care by a family physician.

Control group: Usual care by a family physician.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

There are separate primary outcomes measured for each trial:
Sleep and bedtime problems trial (Trial 1): Parent report on the Children's Sleep Habits Questionnaire
Discipline problems trial (Trial 2): Parent rated total problem score on the Eyberg Child Behavior Inventory
Sleep and Discipline problems trial (Trial 3): Parent report on the Children's Sleep Habits Questionnaire (Group 1 – Sleep treatment) and Parent rated total problem score on the Eyberg Child Behavior Inventory (Group 2 – Discipline treatment)

Secondary outcome measures

1. Parenting practices - Total score on the Parenting Scale
2. General child behavior problems - Total problem score on the Child Behavior Checklist
3. Daily recall ratings of sleep and discipline problems (four reports in total)
4. Parent report on the Richman sleep questionnaire (only for trial 1 [sleep and bedtime problems] and for trial 3 participants if in sleep treatment condition)

Overall trial start date

01/01/2005

Overall trial end date

31/05/2007

Reason abandoned

Eligibility

Participant inclusion criteria

Parents of children aged two to five years of either sex with concerns about their child’s sleep (trial 1), discipline (trial 2), or sleep and discipline (trial 3):
1. Parent (primary caregiver) of 2 - 5 year old child
2. Attending a medical appointment at a family medical practice
3. Phone in home
4. Parent concerned about child’s sleep and/or discipline
5. Parent interested in participating in a treatment study

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

480 (Added 09/08/2011: 548 actually recruited)

Participant exclusion criteria

1. Parent non-English speaking
2. Child with significant physical (e.g. cerebral palsy) or developmental (e.g. Down syndrome) disability
3. Parent’s only sleep concern is in regards to a physiological sleep disorder (e.g. sleep apnea, snoring) or bedwetting

Recruitment start date

01/01/2005

Recruitment end date

31/05/2007

Locations

Countries of recruitment

Canada

Trial participating centre

Social Sciences Centre
London, Ontario
N6A 5C2
Canada

Sponsor information

Organisation

University of Western Ontario (Canada)

Sponsor details

1151 Richmond Street North
London
Ontario
N6A 3K7
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-67816)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The Provincial (Ontario) Centre of Excellence for Child and Youth Mental Health at CHEO (Canada)

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

2013 results in http://www.ncbi.nlm.nih.gov/pubmed/22948337

Publication citations

  1. Results

    Reid GJ, Stewart M, Vingilis E, Dozois DJ, Wetmore S, Jordan J, Dickie G, Osmun WE, Wade TJ, Brown JB, Zaric GS, Randomized trial of distance-based treatment for young children with discipline problems seen in primary health care., Fam Pract, 2013, 30, 1, 14-24, doi: 10.1093/fampra/cms051.

Additional files

Editorial Notes