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- Essai clinique NCT01352468
Development of a Multi-faceted Cognitive Training Program for Children With Attention Deficit Hyperactivity Disorder (ADHD)
19 juin 2017 mis à jour par: Children's Hospital Medical Center, Cincinnati
Development of a Multi-faceted Cognitive Training Program for Children With ADHD
After decades of Attention Deficit Hyperactivity Disorder (ADHD) intervention research, only two intervention approaches (i.e., psychopharmacology, behavioral treatment) have a "well-established" evidence-base supporting their efficacy for children with ADHD.
Both of these interventions have inherent limitations.
Recently multiple studies have demonstrated that cognitive training may improve neuropsychological and behavioral functioning in children with ADHD.
The magnitude of treatment effects for cognitive training has been comparable to treatment effects for behavioral treatment for ADHD (i.e., small to moderate effect sizes).
A limitation of existing cognitive training programs that may limit their efficacy is that each has employed a unifaceted approach.
Each intervention program has targeted a single cognitive domain (e.g., working memory).
This is problematic since as a group, children with ADHD have multiple areas of cognitive deficit (i.e., working memory, attention, response inhibition, delay aversion, intra-individual variability) and thus a unifaceted intervention does not address the multifaceted array of cognitive dysfunction in children with ADHD.
Also, because individuals with ADHD each have unique patterns of cognitive deficits, a unifaceted cognitive training approach may target areas which are non-deficient and miss areas of significant deficit in individual patients depending on their ideographic cognitive profile.
The primary goal of the proposed research is to develop and test a multifaceted cognitive training intervention that addresses a comprehensive array of ADHD-related cognitive deficits thereby ensuring that children's unique areas of cognitive deficit are targeted.
During Phase I (R21 grant), software and a manual will be developed consisting of four training tasks targeting response inhibition, verbal working memory, attention, and delay aversion.
Each task will possess advancing levels of difficulty.
On each task, children will receive feedback on performance accuracy as well as on intra-individual variability in reaction times.
The software will be pilot tested in Phase I to determine performance thresholds and intervention duration.
Also, focus groups will be conducted to obtain patient perceptions of each task's difficulty and interest level.
In Phase II (R33 grant), a preliminary randomized clinical trial will be conducted in order to obtain initial estimates of treatment efficacy.
Pre-, post-, and follow up outcomes will be collected on a wide range of neuropsychological, behavioral, and academic measures.
Effect size estimates across outcomes will be used to guide sample size determinations for future clinical trials of multifaceted cognitive training.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
44
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
-
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Ohio
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Cincinnati, Ohio, États-Unis, 45229
- Cincinnati Childrens Hospital Medical Center
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-
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
7 ans à 12 ans (Enfant)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- Consent: The family must provide signature of informed consent by parents or legal guardians.
- Age at time of Screening: 7 to 12 years of age, inclusive.
- Gender: includes male and female children.
- ADHD Diagnostic Status: ADHD patients must meet DSM-IV criteria for ADHD-PIT or ADHD-CT subtype. Section D.4 below describes in detail the diagnostic process for arriving at diagnosis.
- Cognitive Functioning: IQ of greater than 80 as estimated by the Wechsler Intelligence Scale for Children Fourth Edition.
- Learning Disability: Children must score 75 or above on two of the Wechsler Individual Achievement Test (WIAT) subtests (Reading & Numerical Operations).
- School: Children must be enrolled in a school setting from which teacher ratings can be obtained.
- History of Psychiatric Medications: Children may be taking psychiatric medications. However, they must present with significant ADHD inattention symptoms while on medication in order to be included in the study. We will ask that children on ADHD medications to refrain from altering the dosage for 10 weeks from study enrollment to after the immediate post-intervention follow-up. In order to screen for possible medication adjustments, all parents will be asked during the initial phone screen if their child is on an ADHD medication and if they anticipate a change in that medication dosage. If they answer that they anticipate a dosage change, they will be excluded from the study.
Exclusion Criteria:
- Understanding Level. The patient and parent cannot understand or follow instructions given in the study.
- Exclusionary Psychiatric Conditions: Children who meet diagnostic criteria on the K-SADS for OCD, any psychotic disorder, major depressive disorder or bipolar disorder will be excluded from participation.
- Developmental Disabilities. Patients will be excluded if they are deemed to be significantly developmentally delayed or have a pervasive developmental disorder. Developmental delay will be operationally defined as an IQ score below 80. Children scoring 80 or above will be included. A semi-structured interview, the CAARTE, will be used to screen for autism.
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: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Multifaceted Cognitive Training
Cognitive Training with 4 different tasks each of which gets progressively more difficult as children obtain proficiency.
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Four computerized training tasks
|
|
Comparateur factice: Sham Cognitive Training
Cognitive Training with 4 different tasks which does not get progressively more difficult throughout training
|
Four computerized training tasks
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Total ADHD Symptom Score From Vanderbilt ADHD Parent Rating Scale
Délai: 8 weeks
|
Total ADHD Symptom Score on the Parent Vanderbilt Rating Scales; range = 0-54; this score is computed by summing the 18 ADHD symptom items which are each rated on a 0-3 Likert scale (0="Never"; 1="Occasionally"; 2="Often"; 3="Very often"); higher scores indicate higher severity of ADHD symptoms.
|
8 weeks
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Reaction Time Variability on go/No-go Task
Délai: 8 weeks
|
Standard deviation of reaction times for correct responses to Go trials on a Go/No-Go Task
|
8 weeks
|
|
Proportion of Words Read Accurately Using the AIMSWEB
Délai: 8 weeks
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Number of words read correctly divided by number of words read
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8 weeks
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Collaborateurs
Les enquêteurs
- Chercheur principal: Jeffery N Epstein, Ph.D., Cincinnati Childrens Hospital Medical Center
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 avril 2011
Achèvement primaire (Réel)
1 décembre 2013
Achèvement de l'étude (Réel)
1 juin 2016
Dates d'inscription aux études
Première soumission
24 mars 2011
Première soumission répondant aux critères de contrôle qualité
11 mai 2011
Première publication (Estimation)
12 mai 2011
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
1 août 2017
Dernière mise à jour soumise répondant aux critères de contrôle qualité
19 juin 2017
Dernière vérification
1 juin 2017
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- R33MH085842 (Subvention/contrat des NIH des États-Unis)
- R21MH085842 (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 .