Promoting Development in Toddlers With Communication Delays
13 juni 2012 bijgewerkt door: Autism Speaks
Eighty parent-child dyads will be recruited and randomly assigned to either the experimental intervention or an active control condition.
Subjects assigned to the experimental group will participate in 12 home-based intervention sessions.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
The experimental intervention is manualized, follows an illustrated workbook for parents, and uses individualized video-feedback, modeling, and coaching strategies to help parents establish play interactions that promote communication. All participants take part in comprehensive baseline and post-intervention/post-active control assessments, as well as 6- and 12-month follow up assessments. Families in the active control group will also be invited to participate in an oral feedback session to discuss the results from these assessments. Children's involvement in other forms of intervention will be monitored using a validated intervention log so that the moderating effects of these treatments can be examined.
By targeting parent-child interactions, the current intervention ensures that new child behaviors generalize beyond the immediate context of the intervention and are maintained over time (Schreibman, 2000). In addition, by involving parents in the treatment of their children (e.g., by establishing a daily playtime routine), the current intervention ensures that the intervention strategies are implemented with sufficient intensity for causing developmental change (National Research Council, 2001).
Studietype
Ingrijpend
Inschrijving (Werkelijk)
60
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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California
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Los Angeles, California, Verenigde Staten
- University of California, Los Angeles
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New York
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New York, New York, Verenigde Staten
- Hunter College
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
1 jaar tot 2 jaar (Kind)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
Inclusion Criteria:
- The child is between 15 and 30 months of age;
- The child scores at least one standard deviation below average on the Social Composite Score of the CSBS DP.
Exclusion Criteria:
- The child has been diagnosed with a known medical condition that has been linked to either autism or mental retardation (e.g., Fragile X, Tuberous Sclerosis, Cerebral Palsy, Hydrocephalus).
- The child has a severe visual, hearing, or motor impairment or fragile health condition that would prevent him/her from validly participating in the assessment procedures.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Actieve vergelijker: Active Control
The active control involves three 90 minute in-home training sessions.
These training sessions will be administered by trained graduate students or a postdoctoral student in a developmental psychology or related field.
The active control will follow a standardized treatment manual (Kasari, 2008).
This treatment manual was based upon the teacher training workshops created by the Center on the Social and Emotional Foundations for Early Learning.
Over the course of the intervention, parent and interventionist cover a hierarchy of intervention topics, aiming to improve the parent's ability to successfully promote the child's social and emotional competency.
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The parent education program involves 12 in-home training sessions (90 minutes each), is administered by trained graduate and postdoctoral students in developmental psychology or a related field, and follows a standardized treatment manual (Siller, 2005).
The active control involves three 90 minute in-home training sessions.
These training sessions will be administered by trained graduate students or a postdoctoral student in a developmental psychology or related field.
The active control will follow a standardized treatment manual (Kasari, 2008).
This treatment manual was based upon the teacher training workshops created by the Center on the Social and Emotional Foundations for Early Learning.
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Experimenteel: Experimental Treatment
The parent education program involves 12 in-home training sessions (90 minutes each), is administered by trained graduate and postdoctoral students in developmental psychology or a related field, and follows a standardized treatment manual (Siller, 2005).
Over the course of the intervention, parent and interventionist cover a hierarchy of intervention topics, aiming to promote the ability of the parent-child dyad to successfully manage shared toy play.
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The parent education program involves 12 in-home training sessions (90 minutes each), is administered by trained graduate and postdoctoral students in developmental psychology or a related field, and follows a standardized treatment manual (Siller, 2005).
The active control involves three 90 minute in-home training sessions.
These training sessions will be administered by trained graduate students or a postdoctoral student in a developmental psychology or related field.
The active control will follow a standardized treatment manual (Kasari, 2008).
This treatment manual was based upon the teacher training workshops created by the Center on the Social and Emotional Foundations for Early Learning.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Maternal Synchronization
Tijdsspanne: 3 months
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Maternal Synchronization will be measured at exit of study.
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3 months
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Maternal Synchronization
Tijdsspanne: 6 months
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Maternal Synchronization will be measured at 6 month follow up of study.
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6 months
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Maternal Synchronization
Tijdsspanne: 12 months
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Maternal Synchronization will be measured at 12 month follow up of study.
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12 months
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Early Social Communication Scale
Tijdsspanne: 3 months
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Early Social Communication Scale will be used to measure joint attention behaviors at exit of study.
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3 months
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Early Social Communication Scale
Tijdsspanne: 6 months
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Early Social Communication Scale will be used to measure joint attention at 6 month follow up.
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6 months
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Early Social Communication Scale
Tijdsspanne: 12 months
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Early Social Communication Scale will be used to measure joint attention at 12 month follow up.
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12 months
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Hoofdonderzoeker: Connie Kasari, Ph.D., University of California, Los Angeles
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- Siller M, Sigman M. The behaviors of parents of children with autism predict the subsequent development of their children's communication. J Autism Dev Disord. 2002 Apr;32(2):77-89. doi: 10.1023/a:1014884404276.
- Tomasello M, Carpenter M, Call J, Behne T, Moll H. Understanding and sharing intentions: the origins of cultural cognition. Behav Brain Sci. 2005 Oct;28(5):675-91; discussion 691-735. doi: 10.1017/S0140525X05000129.
- Siller M, Sigman M. Modeling longitudinal change in the language abilities of children with autism: parent behaviors and child characteristics as predictors of change. Dev Psychol. 2008 Nov;44(6):1691-704. doi: 10.1037/a0013771.
- Kasari C, Siller M, Huynh LN, Shih W, Swanson M, Hellemann GS, Sugar CA. Randomized controlled trial of parental responsiveness intervention for toddlers at high risk for autism. Infant Behav Dev. 2014 Nov;37(4):711-21. doi: 10.1016/j.infbeh.2014.08.007. Epub 2014 Sep 26.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 april 2007
Primaire voltooiing (Werkelijk)
1 oktober 2011
Studie voltooiing (Werkelijk)
1 oktober 2011
Studieregistratiedata
Eerst ingediend
10 november 2009
Eerst ingediend dat voldeed aan de QC-criteria
10 november 2009
Eerst geplaatst (Schatting)
11 november 2009
Updates van studierecords
Laatste update geplaatst (Schatting)
14 juni 2012
Laatste update ingediend die voldeed aan QC-criteria
13 juni 2012
Laatst geverifieerd
1 juni 2012
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- G07-02-055-03
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