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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00378157
Other study ID # UUS 29560105
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received September 18, 2006
Last updated February 21, 2011
Start date September 2006
Est. completion date January 2010

Study information

Verified date February 2011
Source Oslo University Hospital
Contact n/a
Is FDA regulated No
Health authority Norway:National Committee for Medical and Health Research Ethics
Study type Interventional

Clinical Trial Summary

The purpose of this study is to investigate the effectiveness of an intervention aimed to increase joint attention in 2-4 year old children with autism. The study will be conducted in mainstream preschools in Norway. The intervention will be implemented by preschool teachers and paraprofessionals supervised by trained counselors.


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.


Recruitment information / eligibility

Status Completed
Enrollment 61
Est. completion date January 2010
Est. primary completion date December 2009
Accepts healthy volunteers No
Gender Both
Age group 24 Months to 60 Months
Eligibility Inclusion Criteria:

- diagnosis of autism

- age 2-4 year old

Exclusion Criteria:

- severe mental retardation

- severe clinical CNS disorders

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Joint attention intervention
Eight weeks with two daily sessions (20 minutes) with joint attention intervention in the pre-school.

Locations

Country Name City State
Norway Ullevaal University Hospital Oslo

Sponsors (2)

Lead Sponsor Collaborator
Ullevaal University Hospital Centre for Child and Adolescent Mental Health

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary childrens score on measures of joint attention pre, post, follow up 6 months and 1 year No
Secondary score on measures of joint engagement -child and mother pre, post, follow up 6 months and 1 year No
Secondary childrens score on measures of language pre and follow up 1 year No
Secondary parents and service providers perception of the intervention post, follow up 6 months and 1 year No
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