- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01941069
School Climate and Children's Behavioral Health (Project Access)
1. februar 2019 opdateret af: Children's Hospital of Philadelphia
Targeting School Climate and Children's Behavioral Health in Urban Schools
The overall purpose of this project is to determine whether school personnel implementing a two-tier School-wide Positive Behavior Support (SWPBS, an evidence based intervention) program for typically developing children as well as children with, or at risk for, externalizing or anxiety disorders can implement the components of the program with the same level of fidelity, integrity and clinical effectiveness when they receive a low level of support (consultation) from their coaches and supervisors as they can with a high level of support (consultation and coaching).
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Demonstrating that school personnel can implement evidence based interventions (EBIs) for externalizing and anxiety problems with a high degree of fidelity, integrity and clinical effectiveness could spur more initiatives toward the adoption of EBIs in urban schools, thus further lowering health disparities in these settings.
The overall purpose of this project is to determine whether school personnel implementing a two-tier School-wide Positive Behavior Support (SWPBS, an evidence based intervention) program for typically developing children as well as children with, or at risk for, externalizing or anxiety disorders can implement the components of the program with the same level of fidelity, integrity and clinical effectiveness when they receive a low level of support (consultation) from their coaches and supervisors as they can with a high level of support (consultation and coaching).
This study will target six schools within the Philadelphia School District (PSD).
Within those 6 schools, research participants will consist of students (grades 4-8) and school staff members.
The investigators will evaluate 1) the effectiveness of SWPBS with consultation and coaching, as compared to the baseline and to SWPBS with consultation only; in reducing office discipline referrals (ODRs) and improving school climate, and children's grades, diagnostic status, symptom severity and impairment; 2) the effectiveness of the SWPBS with consultation and coaching, as compared to SWPBS with consultation only, in increasing program fidelity and integrity.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
437
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Pennsylvania
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Philadelphia, Pennsylvania, Forenede Stater, 19130
- The School District of Philadelphia
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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
8 år til 15 år (Barn)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- All 6 participating schools are included in Tier 1.
- The inclusion criteria for Tier 2 includes children in grades 3-8, who are referred by a school staff member because of behavioral or emotional difficulties or because they have received 3 or more Office Discipline Referrals. Children who consent to participate in the project.
Exclusion Criteria:
- There are no exclusion criteria for Tier 1.
- The exclusion criteria for Tier 2 include any child in grades 3-8 whose family chooses not to consent to screening or participate in the intervention, has Special Education classification of "Intellectual Disability", who is not able to communicate in English, or has a history of psychotic or autistic spectrum disorders.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Aktiv komparator: Internalizing Disorders
Students identified as being at-risk for or meeting criteria for Internalizing Disorders will assigned to this intervention arm.
They will receive the FRIENDS for Life intervention.
FRIENDS is a group Cognitive Behavioral Therapy (CBT) intervention, based on a theoretical model, which addresses cognitive, physiological and behavioral processes that are seen to interact in the development and perpetuation of excessive anxiety.
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Friends for Life is a group CBT intervention, based on a theoretical model, which addresses cognitive, physiological and behavioral processes that are seen to interact in the development and perpetuation of excessive anxiety.
Andre navne:
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Aktiv komparator: Externalizing Disorders
Students identified as being at-risk for or meeting criteria for Externalizing Disorders will be assigned to this intervention arm.
They will receive the Coping Power Program (CPP) intervention.
CPP is a cognitive-behavioral, multi-component group intervention for elementary and middle school students at risk for externalizing behavior disorders.
In addition to anger management, the CPP includes units on goal setting, emotional awareness, relaxation training, social skills training, problem solving, and handling peer pressure.
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The Coping Power Program CPP is a cognitive-behavioral, multi-component group intervention for elementary and middle school students at risk for externalizing behavior disorders.
In addition to anger management, the CPP includes units on goal setting, emotional awareness, relaxation training, social skills training, problem solving, and handling peer pressure.
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Level of Support During Implementation
Tidsramme: 48 months
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To determine whether program fidelity and integrity for Tier 1 (for all students) and Tier 2 (for at risk and high risk students) would differ between schools receiving a high level of support (consultation and coaching) and schools receiving a low level of support (consultation) for program implementers.
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48 months
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Cost Benefit Analyses
Tidsramme: 48 months
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The secondary objectives are to determine the incremental cost-effectiveness of SWPBS HLS (consultation and coaching) versus SWPBS LLS (consultation).
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48 months
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Ricardo B. Eiraldi, PhD, Children's Hospital of Philadelphia
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
- Eiraldi R, Mautone JA, Khanna MS, Power TJ, Orapallo A, Cacia J, Schwartz BS, McCurdy B, Keiffer J, Paidipati C, Kanine R, Abraham M, Tulio S, Swift L, Bressler SN, Cabello B, Jawad AF. Group CBT for Externalizing Disorders in Urban Schools: Effect of Training Strategy on Treatment Fidelity and Child Outcomes. Behav Ther. 2018 Jul;49(4):538-550. doi: 10.1016/j.beth.2018.01.001. Epub 2018 Jan 6.
- Eiraldi R, McCurdy B, Khanna M, Mautone J, Jawad AF, Power T, Cidav Z, Cacia J, Sugai G. A cluster randomized trial to evaluate external support for the implementation of positive behavioral interventions and supports by school personnel. Implement Sci. 2014 Jan 15;9:12. doi: 10.1186/1748-5908-9-12.
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 (Faktiske)
1. januar 2013
Primær færdiggørelse (Faktiske)
30. juni 2018
Studieafslutning (Faktiske)
31. december 2018
Datoer for studieregistrering
Først indsendt
5. september 2013
Først indsendt, der opfyldte QC-kriterier
9. september 2013
Først opslået (Skøn)
13. september 2013
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
4. februar 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
1. februar 2019
Sidst verificeret
1. februar 2019
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 12-009477
- 5R01HD073430-02 (U.S. NIH-bevilling/kontrakt)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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