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Strongest Families (Formerly Family Help Program): Pediatric Attention Deficit/Hyperactivity Disorder (FHPADHD)

I

IWK Health Centre

Status and phase

Completed
Phase 2

Conditions

Attention Deficit/Hyperactivity Disorder

Treatments

Behavioral: ADHD Standard Care
Behavioral: FHPADHD

Study type

Interventional

Funder types

Other

Identifiers

NCT00267605
CHIR CAHR-43273
2234c

Details and patient eligibility

About

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 Attention Deficit/Hyperactivity Disorder. This is a single-centre trial based at the IWK Health Centre. The primary outcome is change in diagnosis.

Full description

The purpose of the Strongest Families (formerly 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 60 children (8-12 years of age)suffering from mild to moderate (but clinically significant) symptoms of pediatric Attention Deficit/Hyperactivity Disorder 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 Strongest Families (formerly 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 Strongest Families treated participants. It is anticipated that Strongest Families treatment will be proven to be as or more effective than standard care.

Enrollment

72 patients

Sex

All

Ages

8 to 12 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • child 3 to 7 years of age
  • child had behavioural problems for 6 months or longer
  • access to a telephone in the home
  • speak and write english
  • mild to moderate attention deficit/hyperactivity symptomology

Exclusion criteria

  • severe attention deficit/hyperactivity symptomology
  • received similar intervention within past 6 months
  • Autism or Schizophrenia
  • child has intellectual impairment

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

72 participants in 2 patient groups

Treatment
Experimental group
Description:
FHPADHD 50% randomized to receive Strongest Families (formerly Family Help Program): behavioural distance intervention
Treatment:
Behavioral: FHPADHD
Control
Active Comparator group
Description:
ADHD Standard Care 50% randomized to receive standard/usual care for ADHD
Treatment:
Behavioral: ADHD Standard Care

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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