Autism Spectrum DisorderNCT00947700
Early Connections, Early Detection and Intervention in Infants at Risk for Autism
A study testing Assessment, Monitoring & Intervention in people with Autism Spectrum Disorder, run by University of Washington at 1 site in United States.
Trial summary
Early connections has two broad goals: to identify risk indices for autism spectrum disorder (ASD) in 6 to 24 month old infants who have an older sibling with ASD or infants who have an older neurotypical sibling. Read more about this study
- Who is it for?
- Ages 5 to 12 monthsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Assessment, Monitoring & Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Jun 2013
- Phase
- Interventional
- 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 5 to 12 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Older sibling with ASD (biologically related to participant)
- Participant 12 months of age or younger
- Within 1 hour of University of Washington
- Interested in participating in Intervention
Who cannot join
- Out of study area
- Serious parent substance abuse or psychiatric history
- Diagnosis of known genetic syndromes or neurological conditions (infant participant or older sibling)
- Serious motor impairment (infant participant)
- Significant prematurity (infant participant)
Trial locations and contacts
1 site in 1 country.
United States1 site
Center on Human Development and Disabilities, University of Washington
Seattle, Washington, 98195
About this study
Official title: UW ACE Project II, Early Detection and Intervention in Infants at Risk for Autism
Early connections has two broad goals:
- to identify risk indices for autism spectrum disorder (ASD) in 6 to 24 month old infants who have an older sibling with ASD or infants who have an older neurotypical sibling.
- to assess whether it is possible to alter risk processes through early intervention with high-risk infants, thereby reducing social-communication delays or the severity of autism symptoms.
Read the detailed description
Researchers at the University of Washington want to learn more about the benefits of early monitoring and intervention for younger siblings of children with autism spectrum disorders (ASD). The information gained in this study may improve methods of early detection and intervention for infants who may be at risk for developing autism and lead to better outcome for these young children and their families.
Participants include families with a child who has been diagnosed with an autism spectrum disorder or typical development and a younger sibling 12 months old or younger. The study protocol includes: (1) comprehensive infant evaluations at the University of Washington Autism Center at 6-months, 12-months, 18-months and 24-months of age. (2) Developmental screening for the older sibling. (3) Questionnaires and phone interviews for parents. (4) Random assignment to an assessment and monitoring intervention group or a University of Washington intervention group. All families will receive advice regarding appropriate intervention services. Families who are assigned to the UW intervention will take part in a parent delivered intervention.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Assessment, Monitoring & Intervention
- Keywords
- Infants, Risk markers, ERP, Parent child interaction, Promoting First Relations, Social Communication
- Medical subject headings
- Autism Spectrum Disorder, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment, Monitoring & InterventionBehavioural
Also called Promoting First Relationships
Assessment and monitoring at 6, 12, 18 and 24 months; Parent delivered intervention provided between 6 and 12 months.
| Study group | Role | What they receive |
|---|---|---|
| Assessment & Monitoring | No intervention | No Intervention. Parent-Child participants in assessment and monitoring visits but does not receive any study provided treatment. |
| Assessment, Monitoring + Intervention | Experimental | Parent-Child participants in assessment and monitoring visits but also the Promoting First Relationships PFR intervention (http://pfrprogram. Org). PFR is a 10 weekly 60-85 minute in-home visits by a masters level mental health provider trained in the PFR curriculum. The PFR curriculum focuses on increasing parenting sensitivity using attachment theory-informed, strength-based consultation strategies. The curriculum is fully manualized and fidelity was assessed according to the manual. Receives: Behavioral: Assessment, Monitoring & Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Autism Symptoms
AOSI
Measured: 12 months
Mullen Receptive Language Scale
Mullen Receptive Language Scale SS
Measured: 12 months
Communication and Symbolic Behavior Scale
CSBS Total Composite Score
Measured: 12 months
Secondary outcomes (2)
Parent Child Interaction
NCAST Caregiver Total
Measured: 12 months
Parent quality of life
Questionnaire on Resources and Stress Total Score
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2009 (estimated)
- Study startJan 2008
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of Environmental Health Sciences (NIEHS), Autism Speaks, Washington State Department of Social and Health Services, Autism Science Foundation
- Responsible party
- Principal investigator, Sara Jane Webb, University of Washington
- Investigators
- Bryan King, MD, Principal investigator, University of WashingtonSara J Webb, PhD, Principal investigator, University of WashingtonAnnette Estes, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00947700
- Sponsor's protocol ID
- 32400
- Other IDs
- P50HD055782, P30ES007033
- Status last verified
- Apr 2017
- First submitted
- 24 Jul 2009
- Last updated
- 20 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Participant level data was submitted to NDAR.
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- UW ACE Project II, Early Detection and Intervention in Infants at Risk for Autism
- ClinicalTrials.gov ID
- NCT00947700
- Acronym / sponsor ID
- 32400
- Conditions
- Autism Spectrum Disorder
- Keywords
- Infants, Risk markers, ERP, Parent child interaction, Promoting First Relations, Social Communication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of Environmental Health Sciences (NIEHS), Autism Speaks, Washington State Department of Social and Health Services, Autism Science Foundation
- Study start
- Jan 2008
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 28 Jul 2009 (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.
Early connections has two broad goals:
- to identify risk indices for autism spectrum disorder (ASD) in 6 to 24 month old infants who have an older sibling with ASD or infants who have an older neurotypical sibling.
- to assess whether it is possible to alter risk processes through early intervention with high-risk infants, thereby reducing social-communication delays or the severity of autism symptoms.
Detailed description
Researchers at the University of Washington want to learn more about the benefits of early monitoring and intervention for younger siblings of children with autism spectrum disorders (ASD). The information gained in this study may improve methods of early detection and intervention for infants who may be at risk for developing autism and lead to better outcome for these young children and their families.
Participants include families with a child who has been diagnosed with an autism spectrum disorder or typical development and a younger sibling 12 months old or younger. The study protocol includes: (1) comprehensive infant evaluations at the University of Washington Autism Center at 6-months, 12-months, 18-months and 24-months of age. (2) Developmental screening for the older sibling. (3) Questionnaires and phone interviews for parents. (4) Random assignment to an assessment and monitoring intervention group or a University of Washington intervention group. All families will receive advice regarding appropriate intervention services. Families who are assigned to the UW intervention will take part in a parent delivered intervention.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Assessment & Monitoring | No intervention | –No Intervention. Parent-Child participants in assessment and monitoring visits but does not receive any study provided treatment. |
| Assessment, Monitoring + Intervention | Experimental | Behavioral: Assessment, Monitoring & InterventionParent-Child participants in assessment and monitoring visits but also the Promoting First Relationships PFR intervention (http://pfrprogram. Org). PFR is a 10 weekly 60-85 minute in-home visits by a masters level mental health provider trained in the PFR curriculum. The PFR curriculum focuses on increasing parenting sensitivity using attachment theory-informed, strength-based consultation strategies. The curriculum is fully manualized and fidelity was assessed according to the manual. |
Who may qualify
- Ages
- 5 to 12 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Older sibling with ASD (biologically related to participant)
- Participant 12 months of age or younger
- Within 1 hour of University of Washington
- Interested in participating in Intervention
Key exclusion criteria (5 listed)
- Out of study area
- Serious parent substance abuse or psychiatric history
- Diagnosis of known genetic syndromes or neurological conditions (infant participant or older sibling)
- Serious motor impairment (infant participant)
- Significant prematurity (infant participant)
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 |
|---|---|---|
| Assessment, Monitoring & InterventionAlso: Promoting First RelationshipsAssessment and monitoring at 6, 12, 18 and 24 months; Parent delivered intervention provided between 6 and 12 months. | Behavioural | Assessment, Monitoring + Intervention |
Primary outcome
Autism Symptoms
Time frame: 12 months
AOSI
Mullen Receptive Language Scale
Time frame: 12 months
Mullen Receptive Language Scale SS
Communication and Symbolic Behavior Scale
Time frame: 12 months
CSBS Total Composite Score
2 secondary outcomes
Parent Child Interaction
Time frame: 12 months
Parent quality of life
Time frame: 12 months
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 20 Apr 2017.
- Individual participant dataSharing planned: No. Participant level data was submitted to NDAR.
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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.
Bryan King, MD principal investigator
University of Washington
Sara J Webb, PhD principal investigator
University of Washington
Annette Estes, PhD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Assessment, Monitoring & Intervention in people with Autism Spectrum Disorder, run by University of Washington 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 4 inclusion and 5 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 20 Apr 2017. 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.
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?
Autism Symptoms (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Apr 2017.