IWK Health Centre
Halifax, Nova Scotia, B3K 6R8, Canada
NCT Number: NCT00267618
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.
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Notify Me9 year–12 year
All sexes
Interventional
Phase 2
Halifax, Nova Scotia, B3K 6R8, Canada
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Evidence-based psychological and behavioural Intervention
Time frame: baseline, 120, 240 and 365 day follow-up
Time frame: daily during treatment; 3 weeks on follow-up at 240 & 365 day post randomization
Time frame: baseline, 120, 240 and 365 day follow-up
Time frame: weekly during treatment; baseline, 120, 240 and 365 day follow-up
Time frame: baseline, 120, 240 and 365 day follow-up
Time frame: baseline, 120, 240 and 365 day follow-up
Time frame: end of intervention
IWK Health Centre
Other
Family Help Program: Primary Care Delivery by Telephone for Psychological and Behavioural Problems (Pediatric Recurrent Headache and Abdominal Pain)
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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