- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT00536094
School-based Treatment for Anxious Children
School-Based CBT for Anxious African-American Children
Přehled studie
Postavení
Podmínky
Detailní popis
Anxiety disorders are among the most common childhood disorders. Although anxiety is a normal part of life and growing up, for some children this anxiety becomes chronic, relentless, and progressively worse if left untreated. Physical symptoms typically accompany the intense anxiety caused by the disorder and may include blushing, profuse sweating, trembling, nausea, and difficulty talking. Anxiety disorders among children have become increasingly prevalent, indicating that excessive fear, worry, and anxiety in children are emerging public health issues. Recent studies have shown that CBT is an effective form of treatment for childhood anxiety disorders; however, it often requires the use of expert CBT clinicians. The purpose of this study is to deliver a school-based version of CBT to predominantly low-income, inner-city, African-American children with anxiety disorders. Clinicians within the school will undergo CBT training and adapt the treatment program to fit the needs of the participating children.
All participants in this study will undergo an initial evaluation to assess anxiety symptoms, disorders, and associated impairments. The children will then be randomly assigned to receive 12 weekly sessions of school-based CBT or treatment as usual, which will involve 12 weekly sessions of psychosocial treatment. Three parent sessions will be offered for families in both groups at Weeks 2, 6, and 10. All treatment sessions will occur at school during the day and will be led by school-based clinicians. A follow-up session will be conducted at post-treatment and 1 month after the last session to assess anxiety symptoms and disorders. Parent, teacher, and clinician ratings will also be used to assess the treatment outcomes of each child.
Typ studie
Zápis (Aktuální)
Fáze
- Fáze 3
Kontakty a umístění
Studijní místa
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Maryland
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Baltimore, Maryland, Spojené státy, 21287
- Johns Hopkins School of Medicine
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- Meets DSM-IV criteria for primary diagnosis of generalized anxiety disorder (GAD), social anxiety disorder (SAD), specific phobia (SP), or social phobia (SOP)
- Received a score of at least 4 on the ADIS for DSM-IV:C's Clinician's Severity Rating Scale (CSR) for GAD, SAD, SP, and/or SOP
- Received a minimum 1 point difference in ADIS for DSM-IV:C severity scores between the primary disorder and other disorders (e.g., depressive disorders, disruptive behavior disorders, attention deficit hyperactive disorder [ADHD], and other anxiety disorders such as obsessive compulsive disorder [OCD], post-traumatic stress disorder [PTSD], acute stress disorder)
Exclusion Criteria:
- Diagnosed with a pervasive developmental disorder, mental retardation, organic mental disorders, schizophrenia, or other psychotic disorders
- Psychotic or suicidal
- Currently receiving treatment for anxiety
- Requires immediate or alternative treatment
- Previously failed a trial of at least 10 sessions for anxiety within 2 years of study entry
- Absent 50% of school days in the 2 months preceding random assignment to treatment groups
- History of child abuse and requires ongoing Department of Social Services supervision
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Trojnásobný
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: 1
Participants will receive cognitive behavioral therapy for anxiety that includes exposure
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CBT includes 45-minute psychotherapy sessions once a week for a period of approximately 12 weeks.
Ostatní jména:
|
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Aktivní komparátor: 2
Participants will receive treatment as usual as delivered by school-based clinicians
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TAU includes 45-minute psychosocial treatment sessions once a week for a period of approximately 12 weeks.
Ostatní jména:
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Časové okno |
|---|---|
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Anxiety Disorders Interview Schedule for DSM-IV: Child Version
Časové okno: Measured at pre-treatment, post-treatment, and one month follow-up
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Measured at pre-treatment, post-treatment, and one month follow-up
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Sekundární výstupní opatření
Měření výsledku |
Časové okno |
|---|---|
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Screen for Child Anxiety Related Disorders (SCARED) - Child Version
Časové okno: Measured at pre-treatment, post-treatment, and one month follow-up
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Measured at pre-treatment, post-treatment, and one month follow-up
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Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Golda Ginsburg, PhD, Johns Hopkins School of Medicine
Publikace a užitečné odkazy
Obecné publikace
- Ginsburg, G. S., Becker, K. D., Kingery, J.,and Nichols, T. (2008). Transporting CBT for childhood anxiety disorders into inner city school-based mental health clinics. Cognitive and Behavioral Practice, 15, 148-158.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- R34MH074552 (Grant/smlouva NIH USA)
- DSIR 84-CTS (Division of Services and Intervention Research)
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