Autism Spectrum DisordersPhase 2NCT01558180
Telephone Care Management to Address Sleep Problems in Young Children With Autism
A Phase 2 study testing Telephone Care Management in people with Autism Spectrum Disorders and Insomnia, run by Nationwide Children's Hospital at 1 site in United States.
Trial summary
The investigators will conduct a randomized controlled trial comparing a telephone based intervention (TCM) to usual care (UC). TCM will feature a registered nurse providing a series of phone calls to assist caregivers in learning and modifying behavioral strategies that may help young children with autism to sleep… Read more about this study
- Who is it for?
- Ages 3 to 6 years
- Conditions the study is for
- Autism Spectrum Disorders, Insomnia
- What is being tested?
- Telephone Care Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to Dec 2013
- Phase
- Phase 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 3 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Insomnia
- Autism Spectrum Disorder
- Regular telephone service for caregiver
- Stable dose of medication
Who cannot join
- Signs of obstructive sleep apnea (e.g., turning blue or stop breathing at night, recurrent snoring)
- Receptive language skills under 18 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
The investigators will conduct a randomized controlled trial comparing a telephone based intervention (TCM) to usual care (UC). TCM will feature a registered nurse providing a series of phone calls to assist caregivers in learning and modifying behavioral strategies that may help young children with autism to sleep better. Objective (activity monitors) and subjective (rating scales) data will be collected by an independent research assistant at the end of the project. The investigators hypothesize that TCM improves sleep duration and decreases sleep problems relative to a usual care control condition (UC).
Read the detailed description
Please see brief summary.
- Conditions
- Autism Spectrum Disorders, Insomnia
- Being tested
- Telephone Care Management, Usual Care
- Medical subject headings
- Autism Spectrum Disorder, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephone Care ManagementBehavioural
Also called TCM
series of phone calls from registered nurse to discuss behavioral suggestions for pediatric insomnia
Usual CareBehavioural
Also called UC
educational handouts on pediatric insomnia
| Study group | Role | What they receive |
|---|---|---|
| Telephone Care Management | Experimental | calls from a registered nurse to educate caregivers about behavioral sleep strategies Receives: Behavioral: Telephone Care Management |
| Usual Care | Placebo comparator | It's a placebo comparator because individuals in this group will receive an educational handout on behavioral sleep strategies. This handout approximates standard of care. Receives: Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Children's Sleep Habits Questionnaire
Measured: 2 month follow-up
Secondary outcomes (1)
Actigraphy (Activity Monitoring)
Measured: 2 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2012 (estimated)
- Study startApr 2012
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisordersStudies of the same condition, open and under way.
- More trials run by Nationwide Children's HospitalThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nationwide Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Ingram Foundation is funding this work.
- Responsible party
- Principal investigator, Jack Stevens, Nationwide Children's Hospital
- Investigators
- Jack Stevens, Ph.D., Principal investigator, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01558180
- Sponsor's protocol ID
- IRB11-00719
- Status last verified
- Feb 2015
- First submitted
- 16 Mar 2012
- Last updated
- 3 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telephone Care Management to Address Sleep Problems in Young Children With Autism
- ClinicalTrials.gov ID
- NCT01558180
- Acronym / sponsor ID
- IRB11-00719
- Conditions
- Autism Spectrum Disorders, Insomnia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Nationwide Children's HospitalUniversity, hospital or other
- Collaborators
- The Ingram Foundation is funding this work.
- Study start
- Apr 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 20 Mar 2012 (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 investigators will conduct a randomized controlled trial comparing a telephone based intervention (TCM) to usual care (UC). TCM will feature a registered nurse providing a series of phone calls to assist caregivers in learning and modifying behavioral strategies that may help young children with autism to sleep better. Objective (activity monitors) and subjective (rating scales) data will be collected by an independent research assistant at the end of the project. The investigators hypothesize that TCM improves sleep duration and decreases sleep problems relative to a usual care control condition (UC).
Detailed description
Please see brief summary.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telephone Care Management | Experimental | Behavioral: Telephone Care Managementcalls from a registered nurse to educate caregivers about behavioral sleep strategies |
| Usual Care | Placebo comparator | Behavioral: Usual CareIt's a placebo comparator because individuals in this group will receive an educational handout on behavioral sleep strategies. This handout approximates standard of care. |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Insomnia
- Autism Spectrum Disorder
- Regular telephone service for caregiver
- Stable dose of medication
Key exclusion criteria (2 listed)
- Signs of obstructive sleep apnea (e.g., turning blue or stop breathing at night, recurrent snoring)
- Receptive language skills under 18 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 |
|---|---|---|
| Telephone Care ManagementAlso: TCMseries of phone calls from registered nurse to discuss behavioral suggestions for pediatric insomnia | Behavioural | Telephone Care Management |
| Usual CareAlso: UCeducational handouts on pediatric insomnia | Behavioural | Usual Care |
Primary outcome
Children's Sleep Habits Questionnaire
Time frame: 2 month follow-up
1 secondary outcome
Actigraphy (Activity Monitoring)
Time frame: 2 month follow up
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 3 Feb 2015.
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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.
Jack Stevens, Ph.D. principal investigator
Nationwide Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Telephone Care Management in people with Autism Spectrum Disorders and Insomnia, run by Nationwide Children's Hospital 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 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 3 Feb 2015. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
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?
Children's Sleep Habits Questionnaire (time frame: 2 month follow-up). 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 3 Feb 2015.