Intervention for Toddlers at Risk for Autism Spectrum Disorders (ASD)
9 marzo 2021 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Effettivo)
49
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
-
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Maryland
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Baltimore, Maryland, Stati Uniti, 21211
- Kennedy Krieger Institute
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-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 11 mesi a 1 anno (Bambino)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Playgroup and Parent Training
|
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.
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.
Altri nomi:
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.
Altri nomi:
|
|
Comparatore attivo: 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.
Altri nomi:
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.
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Developmental Level
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Communication
Lasso di tempo: 3 months after treatment starts
|
Using Communication and Symbolic Behavior Scales to assess.
|
3 months after treatment starts
|
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Communication
Lasso di tempo: 6 months into treatment
|
Using Communication and Symbolic Behavior Scales to assess.
|
6 months into treatment
|
|
Communication
Lasso di tempo: 6 months after treatment ends
|
Using Communication and Symbolic Behavior Scales to assess.
|
6 months after treatment ends
|
|
Presence and Severity of Autism
Lasso di tempo: 3 months after treatment starts
|
Using Autism Diagnostic Observation Schedule to assess.
|
3 months after treatment starts
|
|
Presence and Severity of Autism
Lasso di tempo: 6 months into treatment
|
Using Autism Diagnostic Observation Schedule to assess.
|
6 months into treatment
|
|
Presence and Severity of Autism
Lasso di tempo: 6 months after treatment ends
|
Using Autism Diagnostic Observation Schedule to assess.
|
6 months after treatment ends
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Collaboratori
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- Keen D, Rodger S, Doussin K, Braithwaite M. A pilot study of the effects of a social-pragmatic intervention on the communication and symbolic play of children with autism. Autism. 2007 Jan;11(1):63-71. doi: 10.1177/1362361307070901.
- Solomon R, Necheles J, Ferch C, Bruckman D. Pilot study of a parent training program for young children with autism: the PLAY Project Home Consultation program. Autism. 2007 May;11(3):205-24. doi: 10.1177/1362361307076842.
- Howlin P, Gordon RK, Pasco G, Wade A, Charman T. The effectiveness of Picture Exchange Communication System (PECS) training for teachers of children with autism: a pragmatic, group randomised controlled trial. J Child Psychol Psychiatry. 2007 May;48(5):473-81. doi: 10.1111/j.1469-7610.2006.01707.x.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 gennaio 2008
Completamento primario (Effettivo)
1 dicembre 2011
Completamento dello studio (Effettivo)
1 dicembre 2011
Date di iscrizione allo studio
Primo inviato
21 luglio 2010
Primo inviato che soddisfa i criteri di controllo qualità
10 agosto 2010
Primo Inserito (Stima)
11 agosto 2010
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
10 marzo 2021
Ultimo aggiornamento inviato che soddisfa i criteri QC
9 marzo 2021
Ultimo verificato
1 marzo 2021
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- NA_00006553
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .