Joint Attention Intervention and Young Children With Autism - Tabular View

Tracking Information

First Received Date ^ICMJE

September 18, 2006

Last Updated Date

October 1, 2009

Start Date ^ICMJE

September 2006

Estimated Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

childrens score on measures of joint attention [ Time Frame: pre, post, follow up 6 months and 1 year ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

childrens score on measures of language at 1 year
childrens score on measures of joint attention at 10 weeks, 6 months and 1 year
score on measures of joint engagement -child and mother- at 10 weeks, 6 months and 1 year

Change History

Complete list of historical versions of study NCT00378157 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

score on measures of joint engagement -child and mother [ Time Frame: pre, post, follow up 6 months and 1 year ] [ Designated as safety issue: No ]
childrens score on measures of language [ Time Frame: pre and follow up 1 year ] [ Designated as safety issue: No ]
parents and service providers perception of the intervention [ Time Frame: post, follow up 6 months and 1 year ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

childrens score on measures of play at 10 weeks, 6 months and 1 year
parents score on measures of stress at 1 year
parents and service providers rating of the intervention

Descriptive Information

Brief Title ^ICMJE

Joint Attention Intervention and Young Children With Autism

Official Title ^ICMJE

Effectiveness of Joint Attention Intervention in Young Children With Autism - a Randomized Study

Brief 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.

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 Phase

Phase I, Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Autism

Intervention ^ICMJE

Behavioral: Joint attention intervention

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Estimated Completion Date

December 2010

Estimated Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

diagnosis of autism
age 2-4 year old

Exclusion Criteria:

severe mental retardation
severe clinical CNS disorders

Gender

Both

Ages

24 Months to 60 Months

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Norway

Administrative Information

NCT ID ^ICMJE

NCT00378157

Responsible Party

Ullevaal University Hospital/Centre for Child and Adolescent Mental Health (PI: Anett Kaale, Research Fellow)

Study ID Numbers ^ICMJE

UUS 29560105

Study Sponsor ^ICMJE

Ullevaal University Hospital

Collaborators ^ICMJE

Centre for Child and Adolescent Mental Health

Investigators ^ICMJE

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)

Information Provided By

Ullevaal University Hospital

Verification Date

January 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP