- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01979263
Attention Bias Modification Treatment for Anxious Youth (ABMT)
Studieöversikt
Status
Intervention / Behandling
Detaljerad beskrivning
The purpose of this study is to determine whether or not ABMT computer-based interventions can be used successfully to help reduce anxiety disorder symptoms in children ages 7 to 17. ABMT is different from most other treatments for anxiety because it is not medication or talk therapy. ABMT is a computerized attention training program designed to change how we direct our attention. The purpose of ABMT is to set in place attentional patterns that do not lead to excessive anxiety. Research has shown that it may be highly effective in reducing anxiety. The Intervention will be composed of your child engaging in 6 brief weekly ABMT sessions. The sessions seem like a repetitive computer game.
This study is appropriate for children who may have symptoms of an anxiety disorder, like Generalized Anxiety Disorder, Separation anxiety Disorder, Social Anxiety Disorder, Specific Phobia, or Obsessive-Compulsive Disorder." Children who appear eligible for the study may attend a diagnostic evaluation and assessment if they meet study criteria.
If a child is eligible for the study, he or she will be randomly assigned to either get an "active" form of the computer program or a "placebo" or inactive form of the computer program. The child will come to six weekly appointments at our clinic that are quite brief, about a half hour. Then the child will have an evaluation after the last of the six appointments to see if the computer intervention was helpful in reducing his or her anxiety. We'd then wait a month and then have a final evaluation to see if the child's anxiety has changed over that period of time.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
New York
-
New York, New York, Förenta staterna, 10065
- Payne Whitney Manhattan Child Division
-
White Plains, New York, Förenta staterna, 10605
- New York Presbyterian Hospital--Westchester Division
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Diagnosis on Anxiety Disorders Interview Schedule for Diagnostic and Statistical Manual-IV Child and Parent versions of Separation Anxiety Disorder, Social Phobia, Specific Phobia, Obsessive-Compulsive Disorder, or Generalized Anxiety Disorder
- Age 7 to 17
Exclusion Criteria:
- Posttraumatic stress disorder or primary diagnosis of major depressive disorder
- Seizure disorder
- Current treatment with psychotropic medication
- Multiple chronic learning disabilities and/or conduct problems
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Attention Bias Modification
Attention Bias Modification computer task
|
Computer task aimed at actively modifying attention bias
|
|
Placebo-jämförare: Placebo Computer Task
Placebo computer task
|
Computer task that does not actively modify attention bias
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Change in clinical severity ratings on Anxiety Disorder Interview Schedule-Child and Parent Version
Tidsram: after a 6-week intervention and 4-week no-treatment follow-up
|
after a 6-week intervention and 4-week no-treatment follow-up
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Variation in genes associated with treatment response
Tidsram: week 1
|
We will study allelic variation in a gene that has been associated with treatment response to anxiety interventions, the serotonin-transporter-linked promoter region (5-HTTLPR)
|
week 1
|
Samarbetspartners och utredare
Utredare
- Huvudutredare: Megan H Feltenberger, PhD, Weill Medical College of Cornell University
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 1207012686R001-IRB
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
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