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Combination Treatment for Augmenting Language in Children With ASD (PIII)

27. april 2020 opdateret af: James McCracken, University of California, Los Angeles

Augmenting Language Interventions in ASD: A Translational Approach (ACE Project 3)

The study will consist of two main elements: the enrollment of 72 children aged 6-11 years with ASD and low language competency to receive a thrice-weekly one hour language intervention for 12 weeks; and, beginning at the same time, subjects will be equally randomized to receive either aripiprazole (Abilify) (flexibly dosed from 2-10 mg per day) or placebo for 12 weeks.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Following screening for eligibility and baseline, study visits will be scheduled three times per week, with 2 sessions on-site at UCLA and one at home for parent training (allowing flexibility, as needed); study physician visits will occur once weekly for 6 weeks, then biweekly. Screening procedures may be completed in one or two visits, and measures obtained in other UCLA clinical or research setting may be used if assessments were done within one month of screening. Major outcome assessments will occur at baseline (Week 0), mid-point (Week 6), and final week (Week 12) by study personnel blind to visit number and drug group assignment; minor assessments will occur weekly along with study physician assessments occurring weekly for side effect and compliance checks. EEG will occur at or prior to baseline and at Visit 36 (Wk12). Arrangements will be made to transfer participants to standard clinical care following visit 36. Six months after visit 36, families will be seen for final follow-up assessments of language usage, social communication, overall functioning, health and ongoing treatment.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

58

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • California
      • Los Angeles, California, Forenede Stater, 90095
        • University of California

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

5 år til 11 år (Barn)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion criteria:

  • boys and girls ages 5-11 years;
  • criteria for autistic disorder or PDD-NOS as defined by DSM-IV-TR and confirmed by clinical examination and ADI-R, ADOS;
  • low language usage as defined by <30 functional words obtained from a natural language sample, parent report, and standardized tests;
  • present placement in a comprehensive educational/intervention setting.

Exclusion criteria:

  • any medical condition that would interfere with intervention outcomes during a 12 week study period (eg., active seizures within 3 months);
  • genetic disorders such as Fragile X, Down syndrome, or tuberous sclerosis;
  • sensory impairments such as deafness or blindness;
  • existing or anticipated need for concomitant psychotropic medication (specifically stimulants, atomoxetine) during study participation( allowed medication include: antidepressants, anticonvulsants, guanfacine, clonidine, supplements, melatonin, diphenhydramine);
  • severe aggression or self-injurious behavior;
  • DQ <18 months as assessed by the Leiter-Revised or Mullen.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Aripiprazole
Aripiprazole oral solution (1mg/mL) for 12 weeks. dosages range from 2-10mg per day.
Adfærdsmæssigt: Behavioral Therapy
Thrice-weekly individually based language JAE-EMT intervention will be provided by a trained therapist and taught to the child and their caregivers. A total of 36 sessions will be provided over 12 weeks, with 2 per week at UCLA, and one session per week in the home.
Andre navne:
  • language intervention
Medicin: Aripiprazole
50% of the subjects will be randomized to aripiprazole (active study medication)
Andre navne:
  • dygtiggøre
Aktiv komparator: Placebo
50% will be randomized to placebo.
Adfærdsmæssigt: Behavioral Therapy
Thrice-weekly individually based language JAE-EMT intervention will be provided by a trained therapist and taught to the child and their caregivers. A total of 36 sessions will be provided over 12 weeks, with 2 per week at UCLA, and one session per week in the home.
Andre navne:
  • language intervention
Medicin: Placebo
50% of the subjects will be randomized to placebo (inactive study medication).
Andre navne:
  • inactive study medication
Aktiv komparator: Behavioral Intervention
All subjects will receive behavioral therapy, in addition to either active study drug (aripiprazole) or placebo.
Adfærdsmæssigt: Behavioral Therapy
Thrice-weekly individually based language JAE-EMT intervention will be provided by a trained therapist and taught to the child and their caregivers. A total of 36 sessions will be provided over 12 weeks, with 2 per week at UCLA, and one session per week in the home.
Andre navne:
  • language intervention
Medicin: Aripiprazole
50% of the subjects will be randomized to aripiprazole (active study medication)
Andre navne:
  • dygtiggøre
Medicin: Placebo
50% of the subjects will be randomized to placebo (inactive study medication).
Andre navne:
  • inactive study medication

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of words as assessed in a naturalistic language assessment
Tidsramme: 12 weeks post baseline
word usage coded as assessed by a clinician-administered assessment
12 weeks post baseline

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of California, Los Angeles

Efterforskere

  • Ledende efterforsker: James McCracken, MD, University of California, Los Angeles

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juni 2012

Primær færdiggørelse (Faktiske)

1. december 2019

Studieafslutning (Faktiske)

1. december 2019

Datoer for studieregistrering

Først indsendt

6. oktober 2015

Først indsendt, der opfyldte QC-kriterier

9. oktober 2015

Først opslået (Skøn)

14. oktober 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

29. april 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

27. april 2020

Sidst verificeret

1. april 2020

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 12-000726

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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