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Intervention for Toddlers at Risk for Autism Spectrum Disorders (ASD)

9 mars 2021 mis à jour par: Rebecca Landa, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

A Comprehensive Approach to Intervention for Toddlers at Risk for ASD

This research is being done to test the effectiveness of an early intervention model for very young children at high risk for autism spectrum disorders (ASD) and their families. If children show improvement in this intervention, the investigators hope that the availability of public services of this type will be increased. Children between 11 months and 21 months old with Autism Spectrum Disorders, or with social and communication delays that indicate high risk for Autism Spectrum Disorders, and their parents may join the study. Treatment must start prior to the second birthday.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Réel)

49

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

  • États-Unis
    • Maryland
      • Baltimore, Maryland, États-Unis, 21211
        • Kennedy Krieger Institute

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

11 mois à 1 an (Enfant)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  • Children will be ascertained between 11 months and 21 months of age
  • Must be able to enter the study prior to their second birthday
  • Must then pass an eligibility assessment to determine whether the child meets criteria for ASD and thus qualifies for the study. This assessment will consist of the Baby ADOS and the Mullen Scales of Early Learning. Children must meet criteria for ASD or autism on the ADOS, score more than one standard deviation below the mean on the Receptive or Expressive Language scale of the MSEL, and have a clinical judgment of ASD to be eligible for enrollment into treatment.
  • Parents must agree to participate in the study and commit to having their child participate in the intervention to which they are randomized for 6 months
  • The parent (or other primary caregiver, such as grandparent) in the Parent Enrichment/Training condition must agree to attend the training sessions

Exclusion Criteria:

  • Fail hearing or vision screening (by pediatrician's office, audiologist, or ophthalmologist)
  • Family's first language being other than English (language measures are normed on English speakers, putting non-English speakers at a disadvantage. In addition, the treatment is delivered in English. Children from non-English speaking homes may not make progress, but for reasons other than the efficacy of the intervention.)
  • Head injury (because this may cause some of the symptoms, which may not be due to autism and therefore we would not be able to assess the effects of the intervention on autism)
  • Identified reason for the autism (e.g., fragile X syndrome, Rett syndrome, Tuberous Sclerosis)
  • Inability of the family to attend the playgroup sessions and parent trainings
  • Parents whose hearing or vision is not within normal limits after correction (e.g., hearing aid, glasses)
  • Parents with developmental delays, language or learning impairments, or a psychiatric diagnosis IF the impairment would interfere with parent training (PI will assess on a case by case basis by talking to the parent)
  • Foster children
  • Refusal to allow videotaping of the children's assessments or intervention or to allow videotaped footage to be used for teaching purposes.

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
Expérimental: Playgroup and Parent Training
  1. One to two-hour individual therapeutic sessions with parent training in the home or clinic, 1x every week over six months;
  2. parent training/enrichment once a week in our clinic for 20 sessions at 1-2 hours;
  3. a playgroup session for 1-2 hours 2x week for 6 months in our clinic and
  4. Community treatment as usual.
Comportemental: Playgroup
The playgroup will be conducted at our center and focuses on providing an invigorating learning environment in which emerging skills/knowledge are skillfully brought to a higher level of maturity, integrated with existing abilities, and used functionally. Learning with and through peers, provides the opportunity to address abnormal peer relationships for developmental level. Providing an enriched environment with toys, structured learning, and opportunities for ongoing engagement we offer the children experiences that they would not otherwise have. Parent training sessions will focus on strategies aimed at improving child social engagement and communication. Parent education sessions will focus on topics related to autism, learning styles, interventions, and resources.
Comportemental: Parent Training
The 1-2 hour individual therapeutic sessions with parent training in the home or clinic (1x every week over six months) are based on our own program which is in development. This program focuses on teaching parents how to encourage social and communication skills in their toddlers and also provides comprehensive information about development. Sessions will focus on knowledge of autism, current access to services, general knowledge of strategies used to facilitate child development, advocacy, knowledge of how to access services, and coping strategies.
Autres noms:
  • Enrichment Sessions
Comportemental: Parent Training
In the once-a-week 1 to 2 hour parent training/enrichment, we will ask parents to target specific play and care routines in which they may stimulate their child's development in the ways identified by the therapist. These stimulation times may be provided by the parents, other family members, friends, volunteers or hired assistants. Parents will be encouraged to have their child in direct skill-enhancing engagement for 1-2 hour per day. The therapist will work with the family to identify times during the day that best lend themselves to accomplishing this goal.
Autres noms:
  • Individual Therapeutic Sessions
Comparateur actif: Parent Training
  1. Parent enrichment sessions once a week for 20 sessions (for 1-2 hours)
  2. Community treatment as usual.
Comportemental: Parent Training
The 1-2 hour individual therapeutic sessions with parent training in the home or clinic (1x every week over six months) are based on our own program which is in development. This program focuses on teaching parents how to encourage social and communication skills in their toddlers and also provides comprehensive information about development. Sessions will focus on knowledge of autism, current access to services, general knowledge of strategies used to facilitate child development, advocacy, knowledge of how to access services, and coping strategies.
Autres noms:
  • Enrichment Sessions
Comportemental: Parent Training
In the once-a-week 1 to 2 hour parent training/enrichment, we will ask parents to target specific play and care routines in which they may stimulate their child's development in the ways identified by the therapist. These stimulation times may be provided by the parents, other family members, friends, volunteers or hired assistants. Parents will be encouraged to have their child in direct skill-enhancing engagement for 1-2 hour per day. The therapist will work with the family to identify times during the day that best lend themselves to accomplishing this goal.
Autres noms:
  • Individual Therapeutic Sessions

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Developmental Level
Délai: 3 months into treatment, 6 months into treatment, and 6 months after treatment ends
Using the Mullen Scales of Early Learning to assess.
3 months into treatment, 6 months into treatment, and 6 months after treatment ends

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Communication
Délai: 3 months after treatment starts
Using Communication and Symbolic Behavior Scales to assess.
3 months after treatment starts
Communication
Délai: 6 months into treatment
Using Communication and Symbolic Behavior Scales to assess.
6 months into treatment
Communication
Délai: 6 months after treatment ends
Using Communication and Symbolic Behavior Scales to assess.
6 months after treatment ends
Presence and Severity of Autism
Délai: 3 months after treatment starts
Using Autism Diagnostic Observation Schedule to assess.
3 months after treatment starts
Presence and Severity of Autism
Délai: 6 months into treatment
Using Autism Diagnostic Observation Schedule to assess.
6 months into treatment
Presence and Severity of Autism
Délai: 6 months after treatment ends
Using Autism Diagnostic Observation Schedule to assess.
6 months after treatment ends

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Collaborateurs

Autism Speaks

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

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 2008

Achèvement primaire (Réel)

1 décembre 2011

Achèvement de l'étude (Réel)

1 décembre 2011

Dates d'inscription aux études

Première soumission

21 juillet 2010

Première soumission répondant aux critères de contrôle qualité

10 août 2010

Première publication (Estimation)

11 août 2010

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

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • NA_00006553

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 .

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