Promoting Development in Toddlers With Communication Delays
13 juni 2012 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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).
Studietyp
Interventionell
Inskrivning (Faktisk)
60
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
California
-
Los Angeles, California, Förenta staterna
- University of California, Los Angeles
-
-
New York
-
New York, New York, Förenta staterna
- Hunter College
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
1 år till 2 år (Barn)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: 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.
|
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.
|
|
Experimentell: 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.
|
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Maternal Synchronization
Tidsram: 3 months
|
Maternal Synchronization will be measured at exit of study.
|
3 months
|
|
Maternal Synchronization
Tidsram: 6 months
|
Maternal Synchronization will be measured at 6 month follow up of study.
|
6 months
|
|
Maternal Synchronization
Tidsram: 12 months
|
Maternal Synchronization will be measured at 12 month follow up of study.
|
12 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Early Social Communication Scale
Tidsram: 3 months
|
Early Social Communication Scale will be used to measure joint attention behaviors at exit of study.
|
3 months
|
|
Early Social Communication Scale
Tidsram: 6 months
|
Early Social Communication Scale will be used to measure joint attention at 6 month follow up.
|
6 months
|
|
Early Social Communication Scale
Tidsram: 12 months
|
Early Social Communication Scale will be used to measure joint attention at 12 month follow up.
|
12 months
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Connie Kasari, Ph.D., University of California, Los Angeles
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- 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.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 april 2007
Primärt slutförande (Faktisk)
1 oktober 2011
Avslutad studie (Faktisk)
1 oktober 2011
Studieregistreringsdatum
Först inskickad
10 november 2009
Först inskickad som uppfyllde QC-kriterierna
10 november 2009
Första postat (Uppskatta)
11 november 2009
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
14 juni 2012
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
13 juni 2012
Senast verifierad
1 juni 2012
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- G07-02-055-03
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .