Joint Attention Intervention and Young Children With Autism - Full Text View

Sponsors and Collaborators:	Ullevaal University Hospital Regionsenter for barn og unges psykiske helse
Information provided by:	Ullevaal University Hospital
ClinicalTrials.gov Identifier:	NCT00378157

Purpose

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.

Condition	Intervention	Phase
Autism	Behavioral: Joint attention intervention	Phase I Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Effectiveness of Joint Attention Intervention in Young Children With Autism - a Randomized Study

Resource links provided by NLM:

MedlinePlus related topics: Autism

U.S. FDA Resources

Further study details as provided by Ullevaal University Hospital:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	60
Study Start Date:	September 2006
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	24 Months to 60 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

diagnosis of autism
age 2-4 year old

Exclusion Criteria:

severe mental retardation
severe clinical CNS disorders

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00378157

Contacts

Contact: Anett Kaale, PhD student	+4723492100	anett.kaale@r-bup.no
Contact: Eili Sponheim, PhD	+4723492100	eili.sponhei@medisin.no

Locations

Norway
Ullevaal University Hospital	Recruiting
Oslo, Norway, 0319
Contact: Anett Kaale, PhD student
Principal Investigator: Anett Kaale, PhD student

Sponsors and Collaborators

Ullevaal University Hospital

Regionsenter for barn og unges psykiske helse

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)

More Information

No publications provided

Study ID Numbers:	UUS 29560105
Study First Received:	September 18, 2006
Last Updated:	June 2, 2008
ClinicalTrials.gov Identifier:	NCT00378157 History of Changes
Health Authority:	Norway: The National Committees for Research Ethics in Norway

Keywords provided by Ullevaal University Hospital:

autism
joint attention
infants

intervention
joint engagement
language

Study placed in the following topic categories:

Child Development Disorders, Pervasive
Developmental Disabilities
Mental Disorders

Autistic Disorder
Mental Disorders Diagnosed in Childhood
Autism

Additional relevant MeSH terms:

Child Development Disorders, Pervasive
Mental Disorders
Autistic Disorder
Mental Disorders Diagnosed in Childhood

ClinicalTrials.gov processed this record on July 06, 2009