AutismPhase 1/2NCT00065910
Improving Attention Skills of Children With Autism
A Phase 1/2 study testing Caregiver joint attention intervention in people with Autism, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
Trial summary
Toddlers with autism have poor joint attention skills. Joint attention skills include pointing to objects, following another person's gaze, and responding to invitations to join in a social interaction. Improved joint attention skills may lead to better verbal ability as the child ages. Read more about this study
- Who is it for?
- Ages 12 to 36 months
- Conditions the study is for
- Autism
- What is being tested?
- Caregiver joint attention intervention
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2001to Jan 2006
- 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 12 to 36 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosis of autism based on Autism Diagnostic Interview-Revised (ADI-R) and Autism Diagnostic Observation Schedule (ADOS) criteria
Who cannot join
- Seizures
- Medical or psychiatric diagnoses other than autism that potentially contribute to developmental delay (e.g., genetic syndromes)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Los Angeles
Los Angeles, California, 90095
About this study
Official title: A Joint Attention Intervention With Caregivers and Their Children With Autism
Toddlers with autism have poor joint attention skills. Joint attention skills include pointing to objects, following another person's gaze, and responding to invitations to join in a social interaction. Improved joint attention skills may lead to better verbal ability as the child ages. This study teaches caregivers how to help their toddlers with autism develop joint attention skills.
Read the detailed description
Young children with autism show impairment in joint attention. The impairment affects their ability to sustain a shared interest in social interaction and to use specific joint attention skills, such as pointing and showing. The importance of joint attention is underscored by data suggesting these skills are important to later language skills. Targeting joint attention deficits in developmentally young children using familiar caregivers may result in better child language outcomes. This study will teach caregivers how to initiate and maintain episodes of joint engagement with their children.
Participants will be randomized to either the intervention group or to a wait list control group. Each caregiver and child in the intervention group will participate in 24 1-hour sessions, 3 times a week for 8 weeks. In these sessions, caregivers will be taught 10 different modules for teaching joint attention skills to their children. Outcome measures will include language and joint attention skills in the child and caregiver adherence to the intervention protocols. Children and caregivers will be assessed at baseline, during the course of the 8-week intervention, and 10 weeks after the end of the intervention. Participants assigned to the wait list group will begin the intervention at Week 12.
- Conditions
- Autism
- Being tested
- Caregiver joint attention intervention
- Keywords
- Joint attention, Developmental delay, Caregiver interaction
- Medical subject headings
- Autistic Disorder, Learning Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caregiver joint attention interventionBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2003 (estimated)
- Study startSep 2001
- Study completionJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
- Collaborators
- National Institute of Mental Health (NIMH)
- Investigators
- Connie Kasari, PhD, Principal investigator, University of California, Los Angelos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00065910
- Sponsor's protocol ID
- R21MH064927
- Status last verified
- Jun 2003
- First submitted
- 1 Aug 2003
- Last updated
- 2 Jul 2007
- Results posted
- No
Publications
Kasari C, Gulsrud AC, Wong C, Kwon S, Locke J. Randomized controlled caregiver mediated joint engagement intervention for toddlers with autism. J Autism Dev Disord. 2010 Sep;40(9):1045-56. doi: 10.1007/s10803-010-0955-5.
PubMed 20145986
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Joint Attention Intervention With Caregivers and Their Children With Autism
- ClinicalTrials.gov ID
- NCT00065910
- Acronym / sponsor ID
- R21MH064927
- Conditions
- Autism
- Keywords
- Joint attention, Developmental delay, Caregiver interaction
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Sep 2001
- Study completion
- Jan 2006
- First posted
- 5 Aug 2003 (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.
Toddlers with autism have poor joint attention skills. Joint attention skills include pointing to objects, following another person's gaze, and responding to invitations to join in a social interaction. Improved joint attention skills may lead to better verbal ability as the child ages. This study teaches caregivers how to help their toddlers with autism develop joint attention skills.
Detailed description
Young children with autism show impairment in joint attention. The impairment affects their ability to sustain a shared interest in social interaction and to use specific joint attention skills, such as pointing and showing. The importance of joint attention is underscored by data suggesting these skills are important to later language skills. Targeting joint attention deficits in developmentally young children using familiar caregivers may result in better child language outcomes. This study will teach caregivers how to initiate and maintain episodes of joint engagement with their children.
Participants will be randomized to either the intervention group or to a wait list control group. Each caregiver and child in the intervention group will participate in 24 1-hour sessions, 3 times a week for 8 weeks. In these sessions, caregivers will be taught 10 different modules for teaching joint attention skills to their children. Outcome measures will include language and joint attention skills in the child and caregiver adherence to the intervention protocols. Children and caregivers will be assessed at baseline, during the course of the 8-week intervention, and 10 weeks after the end of the intervention. Participants assigned to the wait list group will begin the intervention at Week 12.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 12 to 36 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Diagnosis of autism based on Autism Diagnostic Interview-Revised (ADI-R) and Autism Diagnostic Observation Schedule (ADOS) criteria
Key exclusion criteria (2 listed)
- Seizures
- Medical or psychiatric diagnoses other than autism that potentially contribute to developmental delay (e.g., genetic syndromes)
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 |
|---|---|---|
| Caregiver joint attention intervention | Behavioural | – |
Primary outcome
Not reported in the source record.
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 2 Jul 2007.
- Derived from this study: PubMed 20145986Kasari C, Gulsrud AC, Wong C, Kwon S, Locke J. Randomized controlled caregiver mediated joint engagement intervention for toddlers with autism. J Autism Dev Disord. 2010 Sep;40(9):1045-56. doi: 10.1007/s10803-010-0955-5.
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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.
Connie Kasari, PhD principal investigator
University of California, Los Angelos
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 Caregiver joint attention intervention in people with Autism, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
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 1 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 2 Jul 2007. 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 United States. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00065910, which also lists 1 linked publication.
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 2 Jul 2007.