Strongest Families (Formerly Family Help Program): Pediatric Disruptive Behaviour Disorder
27. marts 2013 opdateret af: IWK Health Centre
Strongest Families (Formerly Family Help Program):Primary Care Delivery by Telephone for Psychological and Behavioural Problems (Pediatric Disruptive Behaviour Disorder)
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 Disruptive Behaviour symptomology.
This is a single-centre trial based at the IWK Health Centre.
The primary outcome is change in diagnosis.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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 (3-7 years of age)suffering from mild to moderate (but clinically significant) symptoms of pediatric behavior 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 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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
80
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Nova Scotia
-
Halifax, Nova Scotia, Canada, B3K 6R8
- IWK Health Centre
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
3 år til 7 år (Barn)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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 disruptive behaviour symptomology
Exclusion Criteria:
- severe disruptive behaviour symptomology
- received similar intervention within past 6 months
- Autism or Schizophrenia
- child has intellectual impairment
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Treatment
50% randomized to receive Strongest Families (formerly Family Help Program): Behaviour treatment
|
Evidence-based psychological and behavioural Distance Intervention
Andre navne:
|
|
Aktiv komparator: Control
50% randomized to control group: standard/usual care for behaviour disorder
|
Evidence-based psychological and behavioural Distance Intervention
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Diagnose ved hjælp af KSADS ved baseline, 120, 240 og 365 dages opfølgning.
Tidsramme: baseline, 120, 240 og 365 dages opfølgning
|
baseline, 120, 240 og 365 dages opfølgning
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Alabama Parenting Questionnaire
Tidsramme: baseline, 120, 240 and 365 day follow-up
|
baseline, 120, 240 and 365 day follow-up
|
|
Revised Disruptive Disorder Rating Scale
Tidsramme: baseline, 120, 240 and 365 day follow-up
|
baseline, 120, 240 and 365 day follow-up
|
|
Connors rating scale
Tidsramme: baseline, 120, 240 and 365 day follow-up
|
baseline, 120, 240 and 365 day follow-up
|
|
Disability Measure;
Tidsramme: Weekly during treatment; baseline, 120, 240 and 365 day follow-up
|
Weekly during treatment; baseline, 120, 240 and 365 day follow-up
|
|
Børnesundhedsspørgeskema
Tidsramme: baseline, 120, 240 og 365 dages opfølgning
|
baseline, 120, 240 og 365 dages opfølgning
|
|
Økonomisk resultatvurdering
Tidsramme: baseline, 120, 240 og 365 dages opfølgning
|
baseline, 120, 240 og 365 dages opfølgning
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Patrick J. McGrath, PhD., IWK Health Centre
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
- 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.
- 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.
- 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.
- 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.
- McGrath PJ, Lingley-Pottie P, Thurston C, MacLean C, Cunningham C, Waschbusch DA, Watters C, Stewart S, Bagnell A, Santor D, Chaplin W. Telephone-based mental health interventions for child disruptive behavior or anxiety disorders: randomized trials and overall analysis. J Am Acad Child Adolesc Psychiatry. 2011 Nov;50(11):1162-72. doi: 10.1016/j.jaac.2011.07.013. Epub 2011 Sep 3.
- Lingley-Pottie P, Janz T, McGrath PJ, Cunningham C, MacLean C. Outcome progress letter types: parent and physician preferences for letters from pediatric mental health services. Can Fam Physician. 2011 Dec;57(12):e473-81.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. oktober 2003
Primær færdiggørelse (Faktiske)
1. september 2006
Studieafslutning (Faktiske)
1. april 2008
Datoer for studieregistrering
Først indsendt
19. december 2005
Først indsendt, der opfyldte QC-kriterier
20. december 2005
Først opslået (Skøn)
21. december 2005
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
29. marts 2013
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
27. marts 2013
Sidst verificeret
1. marts 2013
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2234b
- CIHR CAHR-43273 (Andet bevillings-/finansieringsnummer: Canadian Institutes of Health Research (CIHR))
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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Ingen
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Ingen
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