AutismPhase 1/2NCT00378157
Joint Attention Intervention and Young Children With Autism
A Phase 1/2 study testing Joint attention intervention in people with Autism, run by Ullevaal University Hospital at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 24 to 60 months
- Conditions the study is for
- Autism
- What is being tested?
- Joint attention intervention
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 61 participants
- Where
- 1 siteNorway
- Study dates
- Sep 2006to Jan 2010
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 60 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- diagnosis of autism
- age 2-4 year old
Who cannot join
- severe mental retardation
- severe clinical CNS disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Joint Attention Intervention in Young Children With Autism - a Randomized Study
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.
Read the 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.
- Conditions
- Autism
- Being tested
- Joint attention intervention
- Keywords
- autism, joint attention, intervention, joint engagement, language
- Medical subject headings
- Autistic Disorder, Language
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Joint attention interventionBehavioural
Eight weeks with two daily sessions (20 minutes) with joint attention intervention in the pre-school.
What is being measured
The primary outcome is the main question the study is designed to answer.
childrens score on measures of joint attention
Measured: pre, post, follow up 6 months and 1 year
Secondary outcomes (3)
score on measures of joint engagement -child and mother
Measured: pre, post, follow up 6 months and 1 year
childrens score on measures of language
Measured: pre and follow up 1 year
parents and service providers perception of the intervention
Measured: post, follow up 6 months and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2006 (estimated)
- Study startSep 2006
- Primary completionDec 2009
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AutismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ullevaal University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Centre for Child and Adolescent Mental Health
- Investigators
- Eili Sponheim, PhD, Study chair, Ullevaal University HospitalLars Smith, PhD, Study chair, University of Oslo (UiO)Berit Grøholt, PhD, Study chair, University of Oslo (UiO)Anett Kaale, PhD student, Principal investigator, Ullevaal University Hospital and Centre for Child and Adolecent Mental Health (R-BUP)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00378157
- Sponsor's protocol ID
- UUS 29560105
- Status last verified
- Feb 2011
- First submitted
- 18 Sep 2006
- Last updated
- 23 Feb 2011
- Results posted
- No
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.
PubMed 24472253Kaale 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.
PubMed 21883204
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Joint Attention Intervention in Young Children With Autism - a Randomized Study
- ClinicalTrials.gov ID
- NCT00378157
- Acronym / sponsor ID
- UUS 29560105
- Conditions
- Autism
- Keywords
- autism, joint attention, intervention, joint engagement, language
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Ullevaal University HospitalUniversity, hospital or other
- Collaborators
- Centre for Child and Adolescent Mental Health
- Study start
- Sep 2006
- Primary completion
- Dec 2009 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 19 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 24 to 60 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- diagnosis of autism
- age 2-4 year old
Key exclusion criteria (2 listed)
- severe mental retardation
- severe clinical CNS disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Joint attention interventionEight weeks with two daily sessions (20 minutes) with joint attention intervention in the pre-school. | Behavioural | – |
Primary outcome
childrens score on measures of joint attention
Time frame: pre, post, follow up 6 months and 1 year
3 secondary outcomes
score on measures of joint engagement -child and mother
Time frame: pre, post, follow up 6 months and 1 year
childrens score on measures of language
Time frame: pre and follow up 1 year
parents and service providers perception of the intervention
Time frame: post, follow up 6 months and 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2011.
- Derived from this study: PubMed 24472253Kaale 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.
- Derived from this study: PubMed 21883204Kaale 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eili Sponheim, PhD study chair
Ullevaal University Hospital
Lars Smith, PhD study chair
University of Oslo (UiO)
Berit Grøholt, PhD study chair
University of Oslo (UiO)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Joint attention intervention in people with Autism, run by Ullevaal University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
childrens score on measures of joint attention (time frame: pre, post, follow up 6 months and 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00378157, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2011.