Family Help Program: Pediatric Recurrent Headache and Abdominal Pain
Primary Purpose
Pediatric Recurrent Headache & Abdominal Pain
Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
FHP Pain
Sponsored by
About this trial
This is an interventional treatment trial for Pediatric Recurrent Headache & Abdominal Pain
Eligibility Criteria
Inclusion Criteria: child 9 to 16 years of age child had recurrent headache and abdominal pain at least 3 times a month child's physical examination normal access to a telephone in the home speak and write english mild to moderate anxiety symptomology Exclusion Criteria: child's pain due to trauma, systemic disease or disorder child received any psychological treatment for this or similar disorder in the past 6 months
Sites / Locations
- IWK Health Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Treatment
control
Arm Description
50% randomized to receive FHP Pain intervention
50% randomized to receive standard/usual care for recurrent headache/abdominal pain
Outcomes
Primary Outcome Measures
Diagnosis using KSADS at baseline, 120, 240 and 365 day follow-up.
Secondary Outcome Measures
Symptomology frequency as evidenced by diary data;
Evaluated according to IHS criteria
Disability Measure;
Child Health Questionnaire
Economic Outcome assessment
Satisfaction measure, designed by the investigator
Full Information
NCT ID
NCT00267618
First Posted
December 19, 2005
Last Updated
June 15, 2015
Sponsor
IWK Health Centre
Collaborators
Canadian Institutes of Health Research (CIHR)
1. Study Identification
Unique Protocol Identification Number
NCT00267618
Brief Title
Family Help Program: Pediatric Recurrent Headache and Abdominal Pain
Official Title
Family Help Program: Primary Care Delivery by Telephone for Psychological and Behavioural Problems (Pediatric Recurrent Headache and Abdominal Pain)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
April 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
IWK Health Centre
Collaborators
Canadian Institutes of Health Research (CIHR)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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 Recurrent Headache/Abdominal Pain symptomology. This is a single-centre trial based at the IWK Health Centre. The primary outcome is change in diagnosis.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Recurrent Headache & Abdominal Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
50% randomized to receive FHP Pain intervention
Arm Title
control
Arm Type
No Intervention
Arm Description
50% randomized to receive standard/usual care for recurrent headache/abdominal pain
Intervention Type
Behavioral
Intervention Name(s)
FHP Pain
Intervention Description
Evidence-based psychological and behavioural Intervention
Primary Outcome Measure Information:
Title
Diagnosis using KSADS at baseline, 120, 240 and 365 day follow-up.
Time Frame
baseline, 120, 240 and 365 day follow-up
Secondary Outcome Measure Information:
Title
Symptomology frequency as evidenced by diary data;
Time Frame
daily during treatment; 3 weeks on follow-up at 240 & 365 day post randomization
Title
Evaluated according to IHS criteria
Time Frame
baseline, 120, 240 and 365 day follow-up
Title
Disability Measure;
Time Frame
weekly during treatment; baseline, 120, 240 and 365 day follow-up
Title
Child Health Questionnaire
Time Frame
baseline, 120, 240 and 365 day follow-up
Title
Economic Outcome assessment
Time Frame
baseline, 120, 240 and 365 day follow-up
Title
Satisfaction measure, designed by the investigator
Time Frame
end of intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
child 9 to 16 years of age
child had recurrent headache and abdominal pain at least 3 times a month
child's physical examination normal
access to a telephone in the home
speak and write english
mild to moderate anxiety symptomology
Exclusion Criteria:
child's pain due to trauma, systemic disease or disorder
child received any psychological treatment for this or similar disorder in the past 6 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick J. McGrath, PhD.
Organizational Affiliation
IWK Health Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
IWK Health Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3K 6R8
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
17227604
Citation
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.
Results Reference
background
PubMed Identifier
19270846
Citation
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.
Results Reference
background
PubMed Identifier
18632994
Citation
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.
Results Reference
background
PubMed Identifier
18025870
Citation
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.
Results Reference
background
PubMed Identifier
18632997
Citation
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.
Results Reference
background
Links:
URL
http://www.bringinghealthhome.com/
Description
Family Help Program
Learn more about this trial
Family Help Program: Pediatric Recurrent Headache and Abdominal Pain
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