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OpenTrials
Completed

NCT Number: NCT00267618

Family Help Program: Pediatric Recurrent Headache and Abdominal Pain

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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Key information

Age range

9 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

IWK Health Centre

Halifax, Nova Scotia, B3K 6R8, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FHP Pain

Behavioral

Evidence-based psychological and behavioural Intervention

Primary outcomes

  1. Diagnosis using KSADS at baseline, 120, 240 and 365 day follow-up.

    Time frame: baseline, 120, 240 and 365 day follow-up

Secondary outcomes

  1. Symptomology frequency as evidenced by diary data;

    Time frame: daily during treatment; 3 weeks on follow-up at 240 & 365 day post randomization

  2. Evaluated according to IHS criteria

    Time frame: baseline, 120, 240 and 365 day follow-up

  3. Disability Measure;

    Time frame: weekly during treatment; baseline, 120, 240 and 365 day follow-up

  4. Child Health Questionnaire

    Time frame: baseline, 120, 240 and 365 day follow-up

  5. Economic Outcome assessment

    Time frame: baseline, 120, 240 and 365 day follow-up

  6. Satisfaction measure, designed by the investigator

    Time frame: end of intervention

Sponsors and collaborators

Lead sponsor

IWK Health Centre

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)

Registry information

Official study title

Family Help Program: Primary Care Delivery by Telephone for Psychological and Behavioural Problems (Pediatric Recurrent Headache and Abdominal Pain)

Important dates

Study start
2004
Primary completion
2007
Study completion
2008
First posted
Dec 21, 2005
Registry last updated
Jun 16, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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