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School-Age Children With Autism With Limited Expressive Language Skills

9 marca 2021 zaktualizowane przez: 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.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

13

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Stany Zjednoczone
    • Maryland
      • Baltimore, Maryland, Stany Zjednoczone, 21211
        • Kennedy Krieger Institute

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

4 lata do 7 lat (Dziecko)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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 studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Zadanie dla jednej grupy
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.
Behawioralne: Non-Verbal School Aged Children with Autism (NVSACA) Intervention

The intervention has 3 components:

  1. One-on-one play based intervention: administered by the interventionist at the school for 1 hour, three times a week, each week for the 5 month duration of the intervention.
  2. Parent training: at the beginning of the 5th month of intervention, parents will receive training once a week for an hour during the remaining four weeks of intervention.
  3. Teacher training: in month 2 of the intervention, the teacher will receive 2 1.5 hour training sessions along with a weekly in-class coaching given as needed following completion of the second session of training.
Eksperymentalny: 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.
Behawioralne: Non-Verbal School Aged Children with Autism (NVSACA) Intervention

The intervention has 3 components:

  1. One-on-one play based intervention: administered by the interventionist at the school for 1 hour, three times a week, each week for the 5 month duration of the intervention.
  2. Parent training: at the beginning of the 5th month of intervention, parents will receive training once a week for an hour during the remaining four weeks of intervention.
  3. Teacher training: in month 2 of the intervention, the teacher will receive 2 1.5 hour training sessions along with a weekly in-class coaching given as needed following completion of the second session of training.
Eksperymentalny: 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.
Behawioralne: Non-Verbal School Aged Children with Autism (NVSACA) Intervention

The intervention has 3 components:

  1. One-on-one play based intervention: administered by the interventionist at the school for 1 hour, three times a week, each week for the 5 month duration of the intervention.
  2. Parent training: at the beginning of the 5th month of intervention, parents will receive training once a week for an hour during the remaining four weeks of intervention.
  3. Teacher training: in month 2 of the intervention, the teacher will receive 2 1.5 hour training sessions along with a weekly in-class coaching given as needed following completion of the second session of training.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Change in Baseline Spontaneous Language
Ramy czasowe: Weekly throughout the 5 month intervention (baseline and 5 months)
The number of unprompted spontaneous language during a 15min play sample.
Weekly throughout the 5 month intervention (baseline and 5 months)

Miary wyników drugorzędnych

Miara wyniku
Ramy czasowe
Change in Baseline Autism Diagnostic Observation Schedule
Ramy czasowe: 5 months into treatment (at completion of intervention)
5 months into treatment (at completion of intervention)
Change in Baseline Reynell
Ramy czasowe: 5 months into treatment (at completion of intervention)
5 months into treatment (at completion of intervention)
Changes in Baseline Early Social Communication Scales (ESCS)
Ramy czasowe: 5 months into treatment (at completion of intervention) and 6 months following the completion of the intervention
5 months into treatment (at completion of intervention) and 6 months following the completion of the intervention
Changes in Baseline Structured Play Assessment
Ramy czasowe: 5 months into treatment (at completion of intervention) and 6 months following the completion of the intervention
5 months into treatment (at completion of intervention) and 6 months following the completion of the intervention

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

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

Współpracownicy

National Institute of Mental Health (NIMH)

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów

1 stycznia 2012

Zakończenie podstawowe (Rzeczywisty)

1 grudnia 2013

Ukończenie studiów (Rzeczywisty)

1 grudnia 2013

Daty rejestracji na studia

Pierwszy przesłany

6 lutego 2012

Pierwszy przesłany, który spełnia kryteria kontroli jakości

8 lutego 2012

Pierwszy wysłany (Oszacować)

9 lutego 2012

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

10 marca 2021

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

9 marca 2021

Ostatnia weryfikacja

1 marca 2021

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • NA_00049467
  • 3R01MH085048-03S1 (Grant/umowa NIH USA)

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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