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- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT00451282
Stepped Preventive Care to Reduce the Impact of Acute Pediatric Injury
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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 3
Contactos e Locais
Locais de estudo
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19104
- Children's Hospital of Philadelphia
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: 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.
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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.
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Sem intervenção: Treatment as usual
Medical and psychosocial care per usual hospital protocols, which may include social work support.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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PTSD Symptoms in Children 6 Weeks Post-injury
Prazo: 6 weeks
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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.
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6 weeks
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PTSD Symptoms in Children 6 Months Post-injury
Prazo: 6 months
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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.
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6 months
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Depression Symptoms in Children 6 Wks Post-injury
Prazo: 6 weeks
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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.
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6 weeks
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Depression Symptoms in Children 6 Mos Post-injury
Prazo: 6 months
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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.
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6 months
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Health-related Quality of Life 6 Weeks and 6 Months Post-injury
Prazo: 6 months
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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.
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6 months
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Adherence With Medical Discharge Instructions
Prazo: 6 months
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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.
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6 months
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Health Service Utilization Over the 6 Months Post-injury
Prazo: 6 months
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Medical records were used as the primary source of service utilization data; parent report supplemented this information if records were unavailable.
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6 months
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Nancy Kassam-Adams, PhD, Center for Injury Research and Prevention, Children's Hospital of Philadelphia
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2006-9-4974
- R49CE000987-01 (Concessão/Contrato do NIH dos EUA)
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
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Norwegian Center for Violence and Traumatic Stress...King's College London; University of Oslo; Ministry of Health and Care Services...RecrutamentoTEPT | Qualidade de vida | Distúrbio do sono | Sintomas DepressivosNoruega
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Silke Wiegand-Grefe, Prof. Dr.Charite University, Berlin, Germany; Hannover Medical School; University Hospital... e outros colaboradoresAtivo, não recrutando
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Weill Medical College of Cornell UniversityCornell UniversityAinda não está recrutandoSobrecarga do cuidadorEstados Unidos
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Barts & The London NHS TrustKing's College Hospital NHS TrustRetiradoDoenças Inflamatórias Intestinais
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Elizabeth Glaser Pediatric AIDS FoundationUnited States Agency for International Development (USAID); Ministry of Health...ConcluídoInfecções por HIVSuazilândia