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Stepped Preventive Care to Reduce the Impact of Acute Pediatric Injury

2. april 2015 opdateret af: Children's Hospital of Philadelphia

This study will evaluate the impact of a brief psychosocial intervention delivered to children or adolescents who are hospitalized for an unintentional injury. The intervention is designed to promote psychological recovery and enhance functional outcomes after injury. The study will also provide preliminary data concerning cost-effectiveness of the intervention.

The core study hypotheses are that children receiving the intervention will (1) have lower severity of post-traumatic stress disorder (PTSD) and depression symptoms at follow-up; (2) show greater adherence to discharge instructions and better health-related quality of life at follow-up, and (3) have higher rates of attendance at scheduled follow-up appointments and lower rates of emergency room utilization and re-hospitalization in the 6 months post-injury, compared to those receiving usual care.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The purpose of this study is to examine the effectiveness of a stepped care model for prevention of psychosocial distress (especially posttraumatic stress) after injury. The model includes screening for risk, standard follow-up with those at risk, and additional evidence-based interventions matched to individual need.

The study will evaluate the impact of the intervention on psychosocial outcomes (PTSD and depression symptoms); as well as health outcomes (adherence to discharge instructions, health-related quality of life), and will provide preliminary data to inform cost-effectiveness analyses by describing the costs of providing the intervention and examining its impact on subsequent health service utilization.

Study Design: 180 children at risk for persistent psychosocial distress post-injury, based on a screening assessment, will be randomized to the Stepped Preventive Care intervention or usual care. An additional comparison group of 90 low risk children will also receive usual care and be followed for assessment.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

290

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater, 19104
        • Children's Hospital of Philadelphia

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

6 år til 15 år (Barn)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Age 8 to 17
  • Admitted to hospital for treatment of unintentional injury
  • Sufficient English fluency to participate in an interview
  • Family has access to a telephone (for telephone follow-up contacts)

Exclusion criteria:

  • Child's medical status or cognitive functioning precludes participating in an interview
  • Child has moderate to severe head injury, defined as Glasgow Coma Score (GCS) <= 12
  • Child's injury involved family violence or abuse (physical or sexual)
  • No parent or guardian available to consent

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Stepped Preventive Care
Receiving Stepped Preventive Care intervention - at least 2 brief assessments with nurse and/or social worker (1) during hospital admission , and (2) approximately 2 weeks post-discharge. Additional interventions provided as needed, based on manual.
Adfærdsmæssigt: stepped preventive care
2 targeted assessments (T1: in hospital within a few days of injury; T2: two weeks post-discharge) are administered by nurse or social worker, and determine need for additional assistance modules. Additional modules include case management, care coordination, assistance with child and family coping with injury/distress, and trauma-focused Cognitive Behavior Therapy (CBT) beginning at 4-6 weeks post-injury if needed.
Ingen indgriben: Treatment as usual
Medical and psychosocial care per usual hospital protocols, which may include social work support.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
PTSD Symptoms in Children 6 Weeks Post-injury
Tidsramme: 6 weeks
The Child PTSD Symptom Scale (CPSS) is a 24-item self-report instrument that yields both a continuous severity score and a determination of likely PTSD diagnostic status according to symptom presence. 17 items corresponding to of the Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV symptom criteria (and are assumed to yield a PTSD symptom severity score range 0-51) and 7 items assess impairment from those symptoms. The 17 symptom items were administered at baseline (prerandomization), with a score of 15 or greater considered a positive screen for PTSD risk (higher values represent more significant severity of and impairment from PTSD symptoms). The 24-item scale was administered at 6 weeks and 6 months postinjury to assess traumatic stress symptom outcomes.
6 weeks
PTSD Symptoms in Children 6 Months Post-injury
Tidsramme: 6 months
The Child PTSD Symptom Scale (CPSS) is a 24-item self-report instrument that yields both a continuous severity score and a determination of likely PTSD diagnostic status according to symptom presence. 17 items corresponding to DSM-IV symptom criteria (and are assumed to yield a PTSD symptom severity score range 0-51) and 7 items assess impairment from those symptoms. The 17 symptom items were administered at baseline (prerandomization), with a score of 15 or greater considered a positive screen for PTSD risk (higher values represent more significant severity of and impairment from PTSD symptoms). The 24-item scale was administered at 6 weeks and 6 months postinjury to assess traumatic stress symptom outcomes.
6 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Depression Symptoms in Children 6 Wks Post-injury
Tidsramme: 6 weeks
The Center for Epidemiologic Studies Depression Scale (CES-D) is a 20-item self-report measure of depression symptoms that yields a total severity score (range 0-60) . Clinical cut-off scores (≥16 for adults and ≥24 for youth) have been empirically established. Higher values represent more significant severity of symptoms of depression. The CES-D has been validated in adults and children 10 and over as an effective screen for depression. The CES-D was administered at baseline (prerandomization), 6 weeks and 6 months postinjury.
6 weeks
Depression Symptoms in Children 6 Mos Post-injury
Tidsramme: 6 months
The Center for Epidemiologic Studies Depression Scale (CES-D) is a 20-item self-report measure of depression symptoms that yields a total severity score (range 0-60) . Clinical cut-off scores (≥16 for adults and ≥24 for youth) have been empirically established. Higher values represent more significant severity of symptoms of depression. The CES-D has been validated in adults and children 10 and over as an effective screen for depression. The CES-D was administered at baseline (prerandomization), 6 weeks and 6 months postinjury.
6 months
Health-related Quality of Life 6 Weeks and 6 Months Post-injury
Tidsramme: 6 months
The Pediatric Quality of Life Inventory is a well-validated measure of child health-related quality of life. Children completed the measure at baseline to report preinjury functioning and at 6-weeks and 6-months postinjury regarding current functioning. Current analyses utilize the 8-item Physical health/Physical functioning subscale. Scores range from 0-100; higher scores indicate better functioning outcomes.
6 months
Adherence With Medical Discharge Instructions
Tidsramme: 6 months
The Health Care Questionnaire for Parents, created for this study, will assess health services utilized post-injury, adherence with specific discharge instructions (e.g., attendance at recommended follow-up appointments), as well as the number of days missed from work (parent) or school (child) related to the injury. Outcome variables to assess adherence will be dichotomized (e.g., attended scheduled appt? yes / no). The Health Care Questionnaire for Primary Care Physicians (PCPs) will assess primary care providers' contacts with study participants, including whether psychosocial concerns were identified since the injury.
6 months
Health Service Utilization Over the 6 Months Post-injury
Tidsramme: 6 months
Medical records were used as the primary source of service utilization data; parent report supplemented this information if records were unavailable.
6 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Children's Hospital of Philadelphia

Samarbejdspartnere

Centers for Disease Control and Prevention

Efterforskere

  • Ledende efterforsker: Nancy Kassam-Adams, PhD, Center for Injury Research and Prevention, 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

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. april 2007

Primær færdiggørelse (Faktiske)

1. juni 2009

Studieafslutning (Faktiske)

1. juni 2009

Datoer for studieregistrering

Først indsendt

22. marts 2007

Først indsendt, der opfyldte QC-kriterier

22. marts 2007

Først opslået (Skøn)

23. marts 2007

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

20. april 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. april 2015

Sidst verificeret

1. april 2015

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2006-9-4974
  • R49CE000987-01 (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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Placeringer

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