School-Age Children With Autism With Limited Expressive Language Skills
9 mars 2021 mis à jour par: Rebecca Landa, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
School-Age Children With Autism With Limited Expressive Language Skills: An Intervention Study
This project will address a major challenge to the field of autism research: improving expressive communication in children with autism who have reached school age but have not acquired functional spoken language (non-verbal school aged children with autism; NVSACA).
Fifteen children who completed the RO1 ICAN intervention (NCT01018407) at the Kennedy Krieger site and follow-up testing but continue to have minimal functional spoken language will be participants in this study. After eligibility is established, participants will be randomly assigned to a baseline duration of one week, two weeks or three weeks before the start of active treatment. Once the baseline duration is completed, participants begin active treatment one hour of intervention three days per week in the participants' school setting. In month 2, weekly teacher trainings begin. In month 5, weekly parent trainings begin to improve the child's generalization of skills and teach parents the strategies implemented in their child's treatment. Post-baseline and post-treatment assessments will be completed in the lab at a time that is convenient for the participants' families.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
13
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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Maryland
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Baltimore, Maryland, États-Unis, 21211
- Kennedy Krieger Institute
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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
4 ans à 7 ans (Enfant)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- Diagnosis of autism by a licensed psychologist or board certified developmental pediatrician, or child and adolescent psychiatrist, confirmed by the Autism Diagnostic Observation Schedule (ADOS; Lord, Rutter, DiLavore, & Risi, 1999)
- Chronological age between 4.0 years and 7 years, 11 months
- Reynell developmental score ≤ 24 months, ADOS A1 score of 2, 3 or 8
- Nonverbal IQ of ≥ 40 (Leiter International Performance Scale-Revised (Leiter-R), Roid & Miller, 2007)
- Children have participated in and completed follow-up testing for the ICAN study.
Exclusion Criteria:
- Major medical conditions other than autism (e.g., genetic disorders [e.g., Fragile X, Down syndrome, tuberous sclerosis], blindness or deafness, and motor disabilities such as cerebral palsy;
- Uncontrolled seizures;
- Self-injurious behavior or moderate to severe aggression.
- Children in foster care.
- Children who are exposed to < 50% English throughout their typical day.
- Children currently participating in another intervention/treatment study.
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 à un seul groupe
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 1 Week Basline Prior to Intervention
If eligible, you will be randomly assigned- as if by flipping a coin- to one of three baseline durations, during which your child will engage in daily interactions with their interventionist to determine if skills targeted by this intervention are improving naturally as your child matures, without active treatment from the study's interventionist.
In this case, the duration is 1 week before your child begins active treatment with their interventionist.
|
The intervention has 3 components:
|
|
Expérimental: 2 Week Basline Prior to Intervention
If eligible, you will be randomly assigned- as if by flipping a coin- to one of three baseline durations, during which your child will engage in daily interactions with their interventionist to determine if skills targeted by this intervention are improving naturally as your child matures, without active treatment from the study's interventionist.
In this case, the duration is 2 weeks before your child begins active treatment with their interventionist.
|
The intervention has 3 components:
|
|
Expérimental: 3 Week Basline Prior to Intervention
If eligible, you will be randomly assigned- as if by flipping a coin- to one of three baseline durations, during which your child will engage in daily interactions with their interventionist to determine if skills targeted by this intervention are improving naturally as your child matures, without active treatment from the study's interventionist.
In this case, the duration is 3 weeks before your child begins active treatment with their interventionist.
|
The intervention has 3 components:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in Baseline Spontaneous Language
Délai: Weekly throughout the 5 month intervention (baseline and 5 months)
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The number of unprompted spontaneous language during a 15min play sample.
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Weekly throughout the 5 month intervention (baseline and 5 months)
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
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Change in Baseline Autism Diagnostic Observation Schedule
Délai: 5 months into treatment (at completion of intervention)
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5 months into treatment (at completion of intervention)
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Change in Baseline Reynell
Délai: 5 months into treatment (at completion of intervention)
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5 months into treatment (at completion of intervention)
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Changes in Baseline Early Social Communication Scales (ESCS)
Délai: 5 months into treatment (at completion of intervention) and 6 months following the completion of the intervention
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5 months into treatment (at completion of intervention) and 6 months following the completion of the intervention
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Changes in Baseline Structured Play Assessment
Délai: 5 months into treatment (at completion of intervention) and 6 months following the completion of the intervention
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5 months into treatment (at completion of intervention) and 6 months following the completion of the intervention
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Collaborateurs
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 janvier 2012
Achèvement primaire (Réel)
1 décembre 2013
Achèvement de l'étude (Réel)
1 décembre 2013
Dates d'inscription aux études
Première soumission
6 février 2012
Première soumission répondant aux critères de contrôle qualité
8 février 2012
Première publication (Estimation)
9 février 2012
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
10 mars 2021
Dernière mise à jour soumise répondant aux critères de contrôle qualité
9 mars 2021
Dernière vérification
1 mars 2021
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- NA_00049467
- 3R01MH085048-03S1 (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 .