- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00378157
Joint Attention Intervention and Young Children With Autism
Effectiveness of Joint Attention Intervention in Young Children With Autism - a Randomized Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Young children with autism experience severe deficit in joint attention skills (e.g. pointing to objects, showing, following another person's gaze, responding to invitations to social interaction). Ability to initiate and respond to joint attention is linked to children's later language abilities. As a mean to improve language outcome in children with autism, it is important to target joint attention in early intervention programs.
This study investigates the effectiveness of a joint attention intervention. Sixty 2-4 year old children with autism will be randomized to an intervention group or a control group. Children in both groups will continue their ordinary preschool program. However, the children in the intervention group will also participate in 80 joint attention intervention sessions. The sessions (20 minutes each) will be conducted twice a day for 8 weeks by preschool teachers or paraprofessionals working in the preschools. Before starting the intervention preschool teachers and paraprofessionals will be taught how to teach joint attention skills and how to initiate and maintain episodes of joint engagement. During the course of intervention they will be supervised by trained counselors.
Outcome measures will include joint attention skills, language skills and joint engagement. Children will be assessed at baseline, after 10 weeks and at follow up 6 months and 1 year after the end of the intervention. The measures are based on direct testing of the children, video observations and questionnaires to parent and professionals.
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
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Oslo, Norway, 0319
- Ullevaal University Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- diagnosis of autism
- age 2-4 year old
Exclusion Criteria:
- severe mental retardation
- severe clinical CNS disorders
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
childrens score on measures of joint attention
Time Frame: pre, post, follow up 6 months and 1 year
|
pre, post, follow up 6 months and 1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
score on measures of joint engagement -child and mother
Time Frame: pre, post, follow up 6 months and 1 year
|
pre, post, follow up 6 months and 1 year
|
childrens score on measures of language
Time Frame: pre and follow up 1 year
|
pre and follow up 1 year
|
parents and service providers perception of the intervention
Time Frame: post, follow up 6 months and 1 year
|
post, follow up 6 months and 1 year
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Eili Sponheim, PhD, Ullevaal University Hospital
- Study Chair: Lars Smith, PhD, University of Oslo (UiO)
- Study Chair: Berit Grøholt, PhD, University of Oslo (UiO)
- Principal Investigator: Anett Kaale, PhD student, Ullevaal University Hospital and Centre for Child and Adolecent Mental Health (R-BUP)
Publications and helpful links
General Publications
- Kaale A, Fagerland MW, Martinsen EW, Smith L. Preschool-based social communication treatment for children with autism: 12-month follow-up of a randomized trial. J Am Acad Child Adolesc Psychiatry. 2014 Feb;53(2):188-98. doi: 10.1016/j.jaac.2013.09.019. Epub 2013 Oct 17.
- Kaale A, Smith L, Sponheim E. A randomized controlled trial of preschool-based joint attention intervention for children with autism. J Child Psychol Psychiatry. 2012 Jan;53(1):97-105. doi: 10.1111/j.1469-7610.2011.02450.x. Epub 2011 Aug 30.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UUS 29560105
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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