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| ID | Type | Description | Link |
|---|---|---|---|
| CHIR CAHR-43273 |
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| Name | Class |
|---|---|
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
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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 Recurrent Headache/Abdominal Pain symptomology. This is a single-centre trial based at the IWK Health Centre. The primary outcome is change in diagnosis.
The purpose of the Family Help Program is to deliver, primary care mental health services to children and their families in the comfort and privacy of their own home. Approximately 106 children (9-12 years of age)suffering from mild to moderate (but clinically significant) symptoms of pediatric Recurrent Headache/Abdominal Pain will be randomized.
The intervention is delivered from a distance, using educational materials (manuals, video-tapes, audio-tapes) 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.
Fifty percent of the eligible participants will receive Family Help Program telephone-based treatment and 50% will be referred back to their family physician to receive standard care as determined by that physician. Those receiving standard care will be evaluated for outcome results and then compared to the Family Help treated participants. It is anticipated that Family Help treatment will be proven to be as or more effective than standard care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | 50% randomized to receive FHP Pain intervention |
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| control | No Intervention | 50% randomized to receive standard/usual care for recurrent headache/abdominal pain |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FHP Pain | Behavioral | Evidence-based psychological and behavioural Intervention |
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| Measure | Description | Time Frame |
|---|---|---|
| Diagnosis using KSADS at baseline, 120, 240 and 365 day follow-up. | baseline, 120, 240 and 365 day follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Symptomology frequency as evidenced by diary data; | daily during treatment; 3 weeks on follow-up at 240 & 365 day post randomization | |
| Evaluated according to IHS criteria | baseline, 120, 240 and 365 day follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patrick J. McGrath, PhD. | IWK Health Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IWK Health Centre | Halifax | Nova Scotia | B3K 6R8 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17227604 | Background | Lingely-Pottie P, McGrath PJ. A therapeutic alliance can exist without face-to-face contact. J Telemed Telecare. 2006;12(8):396-9. doi: 10.1258/135763306779378690. | |
| 19270846 | Background | McGrath PJ, Lingley-Pottie P, Emberly DJ, Thurston C, McLean C. Integrated knowledge translation in mental health: family help as an example. J Can Acad Child Adolesc Psychiatry. 2009 Feb;18(1):30-7. |
| Label | URL |
|---|---|
| Family Help Program | View source |
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| ID | Term |
|---|---|
| D015746 | Abdominal Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Disability Measure; | weekly during treatment; baseline, 120, 240 and 365 day follow-up |
| Child Health Questionnaire | baseline, 120, 240 and 365 day follow-up |
| Economic Outcome assessment | baseline, 120, 240 and 365 day follow-up |
| Satisfaction measure, designed by the investigator | end of intervention |
| 18632994 | Background | Lingley-Pottie P, McGrath PJ. Telehealth: a child and family-friendly approach to mental health-care reform. J Telemed Telecare. 2008;14(5):225-6. doi: 10.1258/jtt.2008.008001. |
| 18025870 | Background | Lingley-Pottie P, McGrath PJ. Distance therapeutic alliance: the participant's experience. ANS Adv Nurs Sci. 2007 Oct-Dec;30(4):353-66. doi: 10.1097/01.ANS.0000300184.94595.25. |
| 18632997 | Background | Lingley-Pottie P, McGrath PJ. A paediatric therapeutic alliance occurs with distance intervention. J Telemed Telecare. 2008;14(5):236-40. doi: 10.1258/jtt.2008.080101. |
| D012817 | Signs and Symptoms, Digestive |