NCT00378157

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Sep 2006

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

September 18, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 19, 2006

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

February 23, 2011

Status Verified

February 1, 2011

Enrollment Period

3.3 years

First QC Date

September 18, 2006

Last Update Submit

February 21, 2011

Conditions

Keywords

autismjoint attentioninterventionjoint engagementlanguage

Outcome Measures

Primary Outcomes (1)

  • childrens score on measures of joint attention

    pre, post, follow up 6 months and 1 year

Secondary Outcomes (3)

  • score on measures of joint engagement -child and mother

    pre, post, follow up 6 months and 1 year

  • childrens score on measures of language

    pre and follow up 1 year

  • parents and service providers perception of the intervention

    post, follow up 6 months and 1 year

Interventions

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

Eligibility Criteria

Age24 Months - 60 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • diagnosis of autism
  • age 2-4 year old

You may not qualify if:

  • severe mental retardation
  • severe clinical CNS disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ullevaal University Hospital

Oslo, 0319, Norway

Location

Related Publications (2)

  • 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.

MeSH Terms

Conditions

Autistic DisorderLanguage

Condition Hierarchy (Ancestors)

Autism Spectrum DisorderChild Development Disorders, PervasiveNeurodevelopmental DisordersMental DisordersCommunicationBehavior

Study Officials

  • Eili Sponheim, PhD

    Ullevaal University Hospital

    STUDY CHAIR
  • Lars Smith, PhD

    University of Oslo (UiO)

    STUDY CHAIR
  • Berit Grøholt, PhD

    University of Oslo (UiO)

    STUDY CHAIR
  • Anett Kaale, PhD student

    Ullevaal University Hospital and Centre for Child and Adolecent Mental Health (R-BUP)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 18, 2006

First Posted

September 19, 2006

Study Start

September 1, 2006

Primary Completion

December 1, 2009

Study Completion

January 1, 2010

Last Updated

February 23, 2011

Record last verified: 2011-02

Locations