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| ID | Type | Description | Link |
|---|---|---|---|
| NSHRF grant | Other Identifier | nshrf |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment: FHP Sleep Program | Experimental | Stratified 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FHP Sleep Program | Behavioral | Cognitive-Behavioral Intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| Child Sleep Habits Questionnaire | baseline, 2months (end of treatment) & 6 month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep diary | daily during treatment; on follow-up at 2 & 6 MONTHS post randomization | |
| Actigraph recordings | daily during treatment; baseline, 2 & 6 months follow-up | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Penny Corkum, PhD. | IWK Health Centre and Dalhousie University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IWK Health Centre | Halifax | Nova Scotia | B3K 6R8 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27189687 | Background | 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. |
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Aggregate summary data would be made available but not individual data.
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| ID | Term |
|---|---|
| D012893 | Sleep Wake Disorders |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Child Behaviour Checklist (CBCL) |
| baseline, 2months (end of treatment) & 6 month follow-up |
| Satisfaction scale (researcher developed) | end of treatment |
| Parenting Stress Index | baseline, 2months (end of treatment) & 6 month follow-up |
| Child Health Questionnaire | baseline, 2months (end of treatment) & 6 month follow-up |
| D001523 | Mental Disorders |