- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01822392
On-line Treatment for Conduct Problems
4 février 2015 mis à jour par: Alan E. Kazdin, Yale University
The research evaluates the use of online versions of delivering an effective psychological treatment for children clinically referred for serious oppositional, aggressive, and antisocial behavior.
The goal is to develop models of delivery that reach families in need that are not being served by in-person treatment.
The project has immediate implications for the treatment of children but more generally addresses several issues critical to treatments that are based on Internet, telepsychiatry, and related technologies.
Aperçu de l'étude
Statut
Complété
Les conditions
Type d'étude
Interventionnel
Inscription (Réel)
86
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
Connecticut
-
New Haven, Connecticut, États-Unis, 06511
- Yale Parenting Center
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
6 ans à 12 ans (Enfant)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- Diagnosis of Conduct Disorder of Oppositional Defiant Disorder (for the child)
- Residence in the state of CT
- Access to a computer and high-speed Internet access
- English fluency (at least one parent)
- No history of significant developmental delay (for the child)
- Parental consent
Exclusion Criteria:
- Participation in another form of psychotherapy or counseling that is directed toward the reduction of social, emotional, or behavioral problems
- Evidence of recent suicidality (for the child)
- Current or lifetime diagnosis of a Pervasive Developmental Disorder
- Primary diagnoses of a mood or anxiety disorder
- Acute family crisis
- Parent or guardian who can participate in treatment shows current psychosis or an uncontrolled medical condition
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Comparateur actif: Online treatment, High therapist contact
Participants receive online Parent Management Training (interactive).
|
|
Expérimental: Online treatment, Low therapist contact
Participants receive online Parent Management Training (recorded).
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Child Behavior Checklist
Délai: Change from pretreatment (Week 0; immediately before the start of treatment) to posttreatment (immediately after treatment is completed; Week 8)
|
Internalizing and externalizing behavior problems in children
|
Change from pretreatment (Week 0; immediately before the start of treatment) to posttreatment (immediately after treatment is completed; Week 8)
|
Child Global Assessment Scale
Délai: Change from pretreatment (Week 0; immediately before the start of treatment) to posttreatment (immediately after treatment is completed; Week 8)
|
Therapist-rated measure of overall child impairment and functioning
|
Change from pretreatment (Week 0; immediately before the start of treatment) to posttreatment (immediately after treatment is completed; Week 8)
|
Interview for Antisocial Behavior
Délai: Change from pretreatment (Week 0; immediately before the start of treatment) to posttreatment (immediately after treatment is completed; Week 8)
|
Presence of a broad range of overt and covert antisocial behaviors in children
|
Change from pretreatment (Week 0; immediately before the start of treatment) to posttreatment (immediately after treatment is completed; Week 8)
|
Research Diagnostic Interview
Délai: Change from pretreatment (Week 0; immediately before the start of treatment) to posttreatment (immediately after treatment is completed; Week 8)
|
Clinical symptoms and diagnoses based on the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) criteria
|
Change from pretreatment (Week 0; immediately before the start of treatment) to posttreatment (immediately after treatment is completed; Week 8)
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Parenting Stress Index
Délai: Change from pretreatment (Week 0; immediately before the start of treatment) to posttreatment (immediately after treatment is completed; Week 8)
|
Sources of stress for the parent
|
Change from pretreatment (Week 0; immediately before the start of treatment) to posttreatment (immediately after treatment is completed; Week 8)
|
Beck Depression Inventory
Délai: Change from pretreatment (Week 0; immediately before the start of treatment) to posttreatment (immediately after treatment is completed; Week 8)
|
Parental symptoms of depression
|
Change from pretreatment (Week 0; immediately before the start of treatment) to posttreatment (immediately after treatment is completed; Week 8)
|
Management of Child Behavior Scale
Délai: Change from pretreatment (Week 0; immediately before the start of treatment) to posttreatment (immediately after treatment is completed; Week 8)
|
Parenting practices
|
Change from pretreatment (Week 0; immediately before the start of treatment) to posttreatment (immediately after treatment is completed; Week 8)
|
Parent-Therapist Relationship Scale (Therapist version)
Délai: Midtreatment (Week 4 of treatment)
|
Characteristics of the therapeutic relationship according to therapist report
|
Midtreatment (Week 4 of treatment)
|
Parent-Therapist Relationship Scale (Therapist version)
Délai: Posttreatment (immediately after treatment is completed; Week 8)
|
Characteristics of the therapeutic relationship according to therapist report
|
Posttreatment (immediately after treatment is completed; Week 8)
|
Parent-Therapist Relationship Scale (Parent version)
Délai: Midtreatment (Week 4 of treatment)
|
Characteristics of the therapeutic relationship according to parent report
|
Midtreatment (Week 4 of treatment)
|
Parent-Therapist Relationship Scale (Parent version)
Délai: Posttreatment (immediately after treatment is completed; Week 8)
|
Characteristics of the therapeutic relationship according to parent report
|
Posttreatment (immediately after treatment is completed; Week 8)
|
Barriers to Participation in Treatment (Therapist version)
Délai: Midtreatment (Week 4 of treatment)
|
Stressors and obstacles that interfere with treatment
|
Midtreatment (Week 4 of treatment)
|
Barriers to Participation in Treatment (Therapist version)
Délai: Posttreatment (immediately after treatment is completed; Week 8)
|
Stressors and obstacles that interfere with treatment
|
Posttreatment (immediately after treatment is completed; Week 8)
|
Barriers to Participation in Treatment (Parent version)
Délai: Midtreatment (Week 4 of treatment)
|
Stressors and obstacles that interfere with treatment
|
Midtreatment (Week 4 of treatment)
|
Barriers to Participation in Treatment (Parent version)
Délai: Posttreatment (immediately after treatment is completed; Week 8)
|
Stressors and obstacles that interfere with treatment
|
Posttreatment (immediately after treatment is completed; Week 8)
|
Weekly Participation in Treatment
Délai: Weekly (during treatment)
|
Attendance and participation in treatment sessions
|
Weekly (during treatment)
|
Treatment Adherence Inventory (Therapist version)
Délai: Midtreatment (Week 4 of treatment)
|
Parental compliance with specific treatment techniques
|
Midtreatment (Week 4 of treatment)
|
Treatment Adherence Inventory (Therapist version)
Délai: Posttreatment (immediately after treatment is completed; Week 8)
|
Parental compliance with specific treatment techniques
|
Posttreatment (immediately after treatment is completed; Week 8)
|
Treatment Adherence Inventory (Parent version)
Délai: Midtreatment (Week 4 of treatment)
|
Parental compliance with specific treatment techniques
|
Midtreatment (Week 4 of treatment)
|
Treatment Adherence Inventory (Parent version)
Délai: Posttreatment (immediately after treatment is completed; Week 8)
|
Parental compliance with specific treatment techniques
|
Posttreatment (immediately after treatment is completed; Week 8)
|
Therapist Evaluation Inventory
Délai: Midtreatment (Week 4 of treatment)
|
Acceptability of treatment based on therapist report
|
Midtreatment (Week 4 of treatment)
|
Therapist Evaluation Inventory
Délai: Posttreatment (immediately after treatment is completed; Week 8)
|
Acceptability of treatment based on therapist report
|
Posttreatment (immediately after treatment is completed; Week 8)
|
Parent Evaluation Inventory
Délai: Midtreatment (Week 4 of treatment)
|
Acceptability of treatment based on parent report
|
Midtreatment (Week 4 of treatment)
|
Parent Evaluation Inventory
Délai: Posttreatment (immediately after treatment is completed; Week 8)
|
Acceptability of treatment based on parent report
|
Posttreatment (immediately after treatment is completed; Week 8)
|
Acceptability of Treatment Modality
Délai: Midtreatment (Week 4 of treatment)
|
Parent-report measure rating the acceptability of online treatment and barriers that may affect participants receiving online treatment specifically
|
Midtreatment (Week 4 of treatment)
|
Acceptability of Treatment Modality
Délai: Posttreatment (immediately after treatment is completed; Week 8)
|
Parent-report measure rating the acceptability of online treatment and barriers that may affect participants receiving online treatment specifically
|
Posttreatment (immediately after treatment is completed; Week 8)
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Perspectives on Treatment Interview
Délai: Posttreatment (immediately after treatment is completed; Week 8)
|
Open-ended interview questions about parents' experiences in treatment and their impressions of different aspects of online treatment delivery
|
Posttreatment (immediately after treatment is completed; Week 8)
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Alan E. Kazdin, Ph.D., Yale University
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 novembre 2012
Achèvement primaire (Réel)
1 décembre 2014
Achèvement de l'étude (Réel)
1 décembre 2014
Dates d'inscription aux études
Première soumission
22 mars 2013
Première soumission répondant aux critères de contrôle qualité
27 mars 2013
Première publication (Estimation)
2 avril 2013
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
6 février 2015
Dernière mise à jour soumise répondant aux critères de contrôle qualité
4 février 2015
Dernière vérification
1 février 2015
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 1108008914
- 1R34MH093326-01A1 (Subvention/contrat des NIH des États-Unis)
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
Essais cliniques sur Online Parent Management Training (Interactive)
-
Taipei Medical UniversityComplété
-
The Hong Kong Polytechnic UniversityRecrutement
-
Hebrew University of JerusalemInconnueTroubles du spectre autistiqueIsraël