Sleep DisorderPhase 2SleepNCT00338429
Better Days, Better Nights: Treatment for Sleep Difficulties (Telephone Coached)
A Phase 2 study testing FHP Sleep Program in people with Sleep Disorder, run by IWK Health Centre at 1 site in Canada.
Trial summary
The purpose of the Strongest Families (formerly Family Help Program)is to evaluate the effectiveness of the Strongest Families distance intervention compared to usual or standard care that is typically provided to children with mild to moderate sleep onset latency and/or bedtime resistance difficulties. Read more about this study
- Who is it for?
- Ages 5 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Disorder
- What is being tested?
- FHP Sleep Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2005to May 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- children 5-12 years of age
- attending grades primary-6 (Elementary School)
- sleep onset latency and/or bedtime resistance
- speak and write English
- provides parental authorization
- has access to telephone in home
Who cannot join
- any mental health disease with the exclusion of disruptive behavior disorder
- neurological conditions
- moderate to severe cognitive impairment
- has received a behavioral intervention for sleep difficulties in the past 6 months
- nocturnal enuresis
- sleep apnea
- co-sleeping
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Better Days, Better Nights: Treatment for Sleep Difficulties (A Sleep Intervention Module of the Family Help Program)
The purpose of the Strongest Families (formerly Family Help Program)is to evaluate the effectiveness of the Strongest Families distance intervention compared to usual or standard care that is typically provided to children with mild to moderate sleep onset latency and/or bedtime resistance difficulties. This is a single-centre trial based at the IWK Health Centre. The primary outcome is change in sleep patterns (sleep onset latency and/or bedtime resistance).
Read the detailed description
The purpose of the Family Help Sleep Program is to deliver, primary care mental health services to children and their families in the comfort and privacy of their own home. Approximately 80 children (6-12 years of age)suffering from mild to moderate sleep onset latency and/or bedtime resistance will be randomized.
The intervention is delivered from a distance, using an educational handbook and telephone consultation with a trained paraprofessional "coach" who is supervised by a licensed health care professional. The telephone coach delivers consistent care based on written protocols, with on-going evaluation by a professional team.
- Conditions
- Sleep Disorder
- Being tested
- FHP Sleep Program
- Keywords
- sleep onset latency, bedtime resistance
- Medical subject headings
- Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FHP Sleep ProgramBehavioural
Cognitive-Behavioral Intervention
| Study group | Role | What they receive |
|---|---|---|
| Treatment: FHP Sleep Program | Experimental | Stratified with or without behavior Disorder Diagnosis (ADHD): 50% randomized to receive Better Days, Better Nights- sleep distance intervention Receives: Behavioral: FHP Sleep Program |
| Control: Usual Care | No intervention | Stratified with/without behavior diagnosis (ADHD): 50% randomized to receive usual care for sleep disorder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child Sleep Habits Questionnaire
Measured: baseline, 2months (end of treatment) & 6 month follow-up
Secondary outcomes (6)
Sleep diary
Measured: daily during treatment; on follow-up at 2 & 6 MONTHS post randomization
Actigraph recordings
Measured: daily during treatment; baseline, 2 & 6 months follow-up
Child Behaviour Checklist (CBCL)
Measured: baseline, 2months (end of treatment) & 6 month follow-up
Satisfaction scale (researcher developed)
Measured: end of treatment
Parenting Stress Index
Measured: baseline, 2months (end of treatment) & 6 month follow-up
Child Health Questionnaire
Measured: baseline, 2months (end of treatment) & 6 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2006 (estimated)
- Study startApr 2005
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- IWK Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Penny Corkum, PhD., Principal investigator, IWK Health Centre and Dalhousie University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00338429
- Sponsor's protocol ID
- 3104
- Other IDs
- NSHRF grant
- Acronym
- Sleep
- Status last verified
- Sep 2016
- First submitted
- 15 Jun 2006
- Last updated
- 2 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Aggregate summary data would be made available but not individual data.
Publications
Corkum P, Lingley-Pottie P, Davidson F, McGrath P, Chambers CT, Mullane J, Laredo S, Woodford K, Weiss SK. Better Nights/Better Days-Distance Intervention for Insomnia in School-Aged Children With/Without ADHD: A Randomized Controlled Trial. J Pediatr Psychol. 2016 Jul;41(6):701-13. doi: 10.1093/jpepsy/jsw031. Epub 2016 May 16.
PubMed 27189687
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Better Days, Better Nights: Treatment for Sleep Difficulties (A Sleep Intervention Module of the Family Help Program)
- ClinicalTrials.gov ID
- NCT00338429
- Acronym / sponsor ID
- Sleep / 3104
- Conditions
- Sleep Disorder
- Keywords
- sleep onset latency, bedtime resistance
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- IWK Health CentreUniversity, hospital or other
- Study start
- Apr 2005
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 20 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the Strongest Families (formerly Family Help Program)is to evaluate the effectiveness of the Strongest Families distance intervention compared to usual or standard care that is typically provided to children with mild to moderate sleep onset latency and/or bedtime resistance difficulties. This is a single-centre trial based at the IWK Health Centre. The primary outcome is change in sleep patterns (sleep onset latency and/or bedtime resistance).
Detailed description
The purpose of the Family Help Sleep Program is to deliver, primary care mental health services to children and their families in the comfort and privacy of their own home. Approximately 80 children (6-12 years of age)suffering from mild to moderate sleep onset latency and/or bedtime resistance will be randomized.
The intervention is delivered from a distance, using an educational handbook and telephone consultation with a trained paraprofessional "coach" who is supervised by a licensed health care professional. The telephone coach delivers consistent care based on written protocols, with on-going evaluation by a professional team.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment: FHP Sleep Program | Experimental | Behavioral: FHP Sleep ProgramStratified with or without behavior Disorder Diagnosis (ADHD): 50% randomized to receive Better Days, Better Nights- sleep distance intervention |
| Control: Usual Care | No intervention | –Stratified with/without behavior diagnosis (ADHD): 50% randomized to receive usual care for sleep disorder |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- children 5-12 years of age
- attending grades primary-6 (Elementary School)
- sleep onset latency and/or bedtime resistance
- speak and write English
- provides parental authorization
Key exclusion criteria (7 listed)
- any mental health disease with the exclusion of disruptive behavior disorder
- neurological conditions
- moderate to severe cognitive impairment
- has received a behavioral intervention for sleep difficulties in the past 6 months
- nocturnal enuresis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FHP Sleep ProgramCognitive-Behavioral Intervention | Behavioural | Treatment: FHP Sleep Program |
Primary outcome
Child Sleep Habits Questionnaire
Time frame: baseline, 2months (end of treatment) & 6 month follow-up
6 secondary outcomes
Sleep diary
Time frame: daily during treatment; on follow-up at 2 & 6 MONTHS post randomization
Actigraph recordings
Time frame: daily during treatment; baseline, 2 & 6 months follow-up
Child Behaviour Checklist (CBCL)
Time frame: baseline, 2months (end of treatment) & 6 month follow-up
Satisfaction scale (researcher developed)
Time frame: end of treatment
Parenting Stress Index
Time frame: baseline, 2months (end of treatment) & 6 month follow-up
Child Health Questionnaire
Time frame: baseline, 2months (end of treatment) & 6 month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2016.
- Background: PubMed 27189687Corkum P, Lingley-Pottie P, Davidson F, McGrath P, Chambers CT, Mullane J, Laredo S, Woodford K, Weiss SK. Better Nights/Better Days-Distance Intervention for Insomnia in School-Aged Children With/Without ADHD: A Randomized Controlled Trial. J Pediatr Psychol. 2016 Jul;41(6):701-13. doi: 10.1093/jpepsy/jsw031. Epub 2016 May 16.
- Individual participant dataSharing planned: No. Aggregate summary data would be made available but not individual data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Penny Corkum, PhD. principal investigator
IWK Health Centre and Dalhousie University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing FHP Sleep Program in people with Sleep Disorder, run by IWK Health Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child Sleep Habits Questionnaire (time frame: baseline, 2months (end of treatment) & 6 month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00338429, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2016; AzTrials last refreshed its copy on 7 Nov 2026.