Autistic DisorderNCT01340092
Use of a Family Navigator in Families With Children Newly Diagnosed With Autism Spectrum Disorder
A study testing Family Navigator in people with Autistic Disorder, run by Boston Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to see whether or not Family Navigators, who 1 ) help families after their child is diagnosed with autism and help them get autism specific services for their child 2) help families identify barriers to obtaining these services and 3) help families problem solve to overcome these barrier… Read more about this study
- Who is it for?
- Ages 15 to 64 years
- Conditions the study is for
- Autistic Disorder
- What is being tested?
- Family Navigator
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to May 2014
- 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 15 to 64 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Child with a new confirmed diagnosis of Autism Spectrum Disorder
- Child is under 8 years of age
- Parent is the mother, father and/or legal guardian of the child and identifies themselves as the primary caregiver
- Primary caregiver speaks English, Spanish, Haitian Creole, Somali, Vietnamese, Portuguese or Chinese
Who cannot join
- Parent or legal guardian has psychosis
- Parent or legal guardian endorses suicidal ideation
- Parent or legal guardian actively using illicit drugs
- Parent or legal guardian expected to leave area within 6 months
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to see whether or not Family Navigators, who 1 ) help families after their child is diagnosed with autism and help them get autism specific services for their child 2) help families identify barriers to obtaining these services and 3) help families problem solve to overcome these barrier, are helpful to parents of a child newly diagnosed with an Autism Spectrum Disorder.
- Conditions
- Autistic Disorder
- Being tested
- Family Navigator
- Keywords
- Family Navigator, Autistic Disorder, Early Intervention, Developmental Disabilities, Child Development Disorders
- Medical subject headings
- Autistic Disorder, Developmental Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family NavigatorOther
Families in the intervention group will receive approximately six sessions with a Family Navigator. The Family Navigator will:
- Help family identify key issues they need to address to get their child autism-specific services
- Help family address barriers to obtaining these services and strategize approaches to overcome them.
| Study group | Role | What they receive |
|---|---|---|
| Family Navigator | Active comparator | Family navigation Receives: Other: Family Navigator |
| Standard Care | No intervention | standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hours of Services
Mean number of autism-specific service hours received per week
Measured: 6 months after enrollment
Receipt of adequate services
As defined by 25 hours/week
Measured: 6 months after enrollment
Time to Receipt of Services
Difference between the date of the IEP/IFPS and date the child first received services
Measured: 6 months after enrollment
Secondary outcomes (2)
Family Psychological Functioning
- Quick Inventory of Depressive Symptomatology-Self Rated (QIDS-SR).
- Parenting Stress - Short Form (PSI)
- Perceived Stress Scale- Self-Report (PSS)
- Medical Outcomes Study Social Support (MOS-SS)
Measured: 6 months after enrollment
Family Psychological Functioning
- Quick Inventory of Depressive Symptomatology-Self Rated (QIDS-SR).
- Parenting Stress - Short Form (PSI)
- Perceived Stress Scale- Self-Report (PSS)
- Medical Outcomes Study Social Support (MOS-SS)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2011 (estimated)
- Study startApr 2011
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autistic DisorderStudies of the same condition, open and under way.
- More trials run by Boston Medical CenterThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marilyn Augustyn, Boston Medical Center
- Investigators
- Marilyn Augustyn, MD, Principal investigator, Boston Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01340092
- Sponsor's protocol ID
- 29964
- Other IDs
- HRSA R40MC19928-01-00
- Status last verified
- Apr 2016
- First submitted
- 20 Apr 2011
- Last updated
- 25 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of a Family Navigator in Families With Children Newly Diagnosed With Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT01340092
- Acronym / sponsor ID
- 29964
- Conditions
- Autistic Disorder
- Keywords
- Family Navigator, Autistic Disorder, Early Intervention, Developmental Disabilities, Child Development Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 22 Apr 2011 (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 see whether or not Family Navigators, who 1 ) help families after their child is diagnosed with autism and help them get autism specific services for their child 2) help families identify barriers to obtaining these services and 3) help families problem solve to overcome these barrier, are helpful to parents of a child newly diagnosed with an Autism Spectrum Disorder.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Family Navigator | Active comparator | Other: Family NavigatorFamily navigation |
| Standard Care | No intervention | –standard care |
Who may qualify
- Ages
- 15 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Child with a new confirmed diagnosis of Autism Spectrum Disorder
- Child is under 8 years of age
- Parent is the mother, father and/or legal guardian of the child and identifies themselves as the primary caregiver
- Primary caregiver speaks English, Spanish, Haitian Creole, Somali, Vietnamese, Portuguese or Chinese
Key exclusion criteria (4 listed)
- Parent or legal guardian has psychosis
- Parent or legal guardian endorses suicidal ideation
- Parent or legal guardian actively using illicit drugs
- Parent or legal guardian expected to leave area within 6 months
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 |
|---|---|---|
| Family NavigatorFamilies in the intervention group will receive approximately six sessions with a Family Navigator. The Family Navigator will: 1. Help family identify key issues they need to address to get their child autism-specific services 2. Help family address barriers to obtaining these services and strategize approaches to overcome them. | Other | Family Navigator |
Primary outcome
Hours of Services
Time frame: 6 months after enrollment
Mean number of autism-specific service hours received per week
Receipt of adequate services
Time frame: 6 months after enrollment
As defined by 25 hours/week
Time to Receipt of Services
Time frame: 6 months after enrollment
Difference between the date of the IEP/IFPS and date the child first received services
2 secondary outcomes
Family Psychological Functioning
Time frame: 6 months after enrollment
Family Psychological Functioning
Time frame: Baseline
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 25 Apr 2016.
- Individual participant dataSharing planned: No
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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.
Marilyn Augustyn, MD principal investigator
Boston Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family Navigator in people with Autistic Disorder, run by Boston Medical Center 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 4 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 25 Apr 2016. 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?
Hours of Services (time frame: 6 months after enrollment). 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 25 Apr 2016.