InsomniaNCT02780596
Infant Night Wakings in Pediatric Primary Care
A study testing Item1, Item2 and Item3 in people with Insomnia and Night Wakings, run by Indiana University at 1 site in United States.
Trial summary
This study aims to: 1. identify which single item or combination of two items perform best in identifying problematic infant night wakings and 2. describe current practices by pediatricians in addressing problematic infant night wakings. Read more about this study
- Who is it for?
- Ages 5 to 20 months
- Conditions the study is for
- Insomnia, Night Wakings
- What is being tested?
- Item1, Item2 and Item3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,501 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to Nov 2017
- 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 20 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infant between the ages of 5 and 20 months (at the time of the visit)
- Caregiver responds to questions on the prescreening form in the waiting room
- Infant is a patient at one of five participating primary care health clinics in Indianapolis Indiana.
- For participation in the phone interviews, caregiver speaks English.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University School of Medicine
Indianapolis, Indiana, 46202
About this study
Official title: Management of Infant Night Wakings in Pediatric Primary Care
This study aims to:
- identify which single item or combination of two items perform best in identifying problematic infant night wakings and
- describe current practices by pediatricians in addressing problematic infant night wakings.
Using a novel computer decision support system in several primary care clinics, caregivers accompanying their child to a health visit will be randomly assigned to receive two of five items assessing night wakings and/or sleep problems, followed by a validated questionnaire for infant night wakings. If caregiver responses to the items suggest a possible sleep problem, pediatricians will receive a prompt in the electronic health record identifying a possible infant sleep problem. A sub-sample of caregivers will then be interviewed regarding the content of the visit that day.
Read the detailed description
Study investigators have developed a novel decision support system for implementing clinical guidelines in pediatric practices. CHICA (Child Health Improvement through Computer Automation) combines three elements:
- pediatric guidelines encoded in Arden Syntax;
- a dynamic, scannable paper user interface; and
- an HL7-compliant interface to existing electronic medical record systems.
The result is a system that both delivers "just-in-time" patient-relevant guidelines to physicians during the clinical encounter and accurately captures structured data from all who interact with it. Preliminary work with CHICA has demonstrated the feasibility of using the system to implement and evaluate clinical guidelines.
Investigators propose to expand CHICA to include surveillance and screening algorithms for problematic infant night wakings. While an eventual aim is to create and test specific management tools for addressing sleep problems, aims of the current study focus on 1) testing items for the identification of sleep disruption, and 2) identifying current management practices in pediatric primary care.
All caregivers of children between the ages of 5 and 20 months presenting to one of five primary care health clinics will be randomly assigned to receive two of five items pertaining to sleep on the prescreening form (PSF) that is currently administered as part of standard clinical care. Parents will have the option to respond "yes" or "no." Regardless of their responses on the pre-screener form, each parent will then receive a form containing ten items from the Infant Sleep Questionnaire (ISQ). Two combinations of items that are similar (Items 1/2 and Items 3/4) will not be presented together, resulting in 8 possible arms or combinations of items.
If a child is identified as possibly having a sleep disturbance (e.g., caregiver answered yes to one or two items), CHICA will prominently display this information on the physician worksheet, viewed during the office visit. The PCP will receive feedback (e.g, "CHILD NAME may have problematic night wakings") via the electronic health record. At this time, providers will not be given additional guidance about how to proceed. At the end of the visit, the provider will be asked to indicate whether or not a sleep problem was confirmed based on their clinical judgment.
A sub-sample of caregivers whose primary care provider (PCP) confirmed a sleep problem will be contacted by phone within two weeks of the clinic visit and asked to complete an exit interview. Caregivers will be asked questions about their child's sleep, the content of the visit with their pediatrician that day (e.g., what the pediatrician recommended), their perceptions of those recommendations, and the outcome of those recommendations if they attempted them. Exit interviews will be conducted on an on-going basis until a sample of 100 has been completed. Up to 600 families may be contacted in order to complete 100 interviews.
Collaborators on this study include the following individuals:
Stephen Downs, MD, Indiana University School of Medicine; Tamara Dugan MS, Indiana University School of Medicine; Amy Schwichtenberg, PhD, Purdue University; and Jodi Mindell, PhD; St. Joseph's University
- Conditions
- Insomnia, Night Wakings
- Being tested
- Item1, Item2, Item3, Item4, Item5
- Keywords
- Infant, Toddler, Primary Care
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Item1Other
Does CHILD NAME often wake one or more times during the night?
Item2Other
Does CHILD NAME often wake one or more times per night, and does and adult go to him/her?
Item3Other
Do you think CHILD'S SLEEP is a problem?
Item4Other
Do you think CHILD NAME has a sleep problem?
Item5Other
Do you have any concerns about CHILD NAME'S sleep?
| Study group | Role | What they receive |
|---|---|---|
| Items1;3 | Experimental | Caregiver is randomly assigned to receive screening items 1 and 3. Item 1: Does CHILD NAME often wake one or more times during the night? Item 3: Do you think CHILD NAME's sleep is a problem? Receives: Other: Item1; Other: Item3 |
| Items1;4 | Experimental | Caregiver is randomly assigned to receive screening items 1 and 4. Item 1: Does CHILD NAME often wake one or more times during the night? Item 4: Does you think CHILD NAME has a sleep problem? Receives: Other: Item1; Other: Item4 |
| Items1;5 | Experimental | Caregiver is randomly assigned to receive screening items 1 and 5. Item 1: Does CHILD NAME often wake one or more times during the night? Item 5: Do you have any concerns about CHILD NAME's sleep? Receives: Other: Item1; Other: Item5 |
| Items2;3 | Experimental | Caregiver is randomly assigned to receive screening items 2 and 3. Item 2: Does CHILD NAME often wake one or more times per night and does an adult go to him/her? Item 3: Do you think CHILD NAME's sleep is a problem? Receives: Other: Item2; Other: Item3 |
| Items2;4 | Experimental | Caregiver is randomly assigned to receive screening items 2 and 4. Item 2: Does CHILD NAME often wake one or more times per night and does an adult go to him/her? Item 4: Does you think CHILD NAME has a sleep problem? Receives: Other: Item2; Other: Item4 |
| Items2;5 | Experimental | Caregiver is randomly assigned to receive screening items 2 and 5. Item 2: Does CHILD NAME often wake one or more times per night and does an adult go to him/her? Item 5: Do you have any concerns about CHILD NAME's sleep? Receives: Other: Item2; Other: Item5 |
| Items3;5 | Experimental | Caregiver is randomly assigned to receive screening items 3 and 5. Item 3: Do you think CHILD NAME's sleep is a problem? Item 5: Do you have any concerns about CHILD NAME's sleep? Receives: Other: Item3; Other: Item5 |
| Items4;5 | Experimental | Caregiver is randomly assigned to receive screening items 4 and 5. Item 4: Does you think CHILD NAME has a sleep problem? Item 5: Do you have any concerns about CHILD NAME's sleep? Receives: Other: Item4; Other: Item5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Problematic infant night wakings (per validated questionnaire)
Identifying the individual item or combination of two items that most strongly predict a positive score on the Infant Sleep Questionnaire
Measured: On the day of each visit to the PCP for the duration of the study (18 months) or until patient no longer meets eligibility (e.g. ages out).
Secondary outcomes (2)
Problematic infant night wakings (per provider clinical judgment)
Identifying the individual item or combination of two items that most strongly predict a provider endorsement of a sleep problem
Measured: On the day of each visit to the PCP for the duration of the study (18 months) or until patient no longer meets eligibility (e.g. ages out).
Night wakings management (per caregiver report)
Descriptive and qualitative responses from the caregiver phone interview. Variables of interest include 1) caregiver description of provider recommendations to address night wakings; 2) caregiver perception of these recommendations; 3) outcome of the recommended action.
Measured: Within two weeks after the visit to the primary care provider
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2016 (estimated)
- Study startFeb 2016
- Primary completionNov 2017
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3,501 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Indiana University Health
- Responsible party
- Principal investigator, Sarah Honaker, Indiana University
- Investigators
- Sarah M Honaker, PhD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02780596
- Sponsor's protocol ID
- 1506090982
- Other IDs
- N109471
- Status last verified
- Feb 2018
- First submitted
- 16 May 2016
- Last updated
- 22 Feb 2018
- 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 22 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Infant Night Wakings in Pediatric Primary Care
- ClinicalTrials.gov ID
- NCT02780596
- Acronym / sponsor ID
- 1506090982
- Conditions
- Insomnia, Night Wakings
- Keywords
- Infant, Toddler, Primary Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,501 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Indiana University Health
- Study start
- Feb 2016 (actual)
- Primary completion
- Nov 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 23 May 2016 (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.
This study aims to:
- identify which single item or combination of two items perform best in identifying problematic infant night wakings and
- describe current practices by pediatricians in addressing problematic infant night wakings.
Using a novel computer decision support system in several primary care clinics, caregivers accompanying their child to a health visit will be randomly assigned to receive two of five items assessing night wakings and/or sleep problems, followed by a validated questionnaire for infant night wakings. If caregiver responses to the items suggest a possible sleep problem, pediatricians will receive a prompt in the electronic health record identifying a possible infant sleep problem. A sub-sample of caregivers will then be interviewed regarding the content of the visit that day.
Detailed description
Study investigators have developed a novel decision support system for implementing clinical guidelines in pediatric practices. CHICA (Child Health Improvement through Computer Automation) combines three elements:
- pediatric guidelines encoded in Arden Syntax;
- a dynamic, scannable paper user interface; and
- an HL7-compliant interface to existing electronic medical record systems.
The result is a system that both delivers "just-in-time" patient-relevant guidelines to physicians during the clinical encounter and accurately captures structured data from all who interact with it. Preliminary work with CHICA has demonstrated the feasibility of using the system to implement and evaluate clinical guidelines.
Investigators propose to expand CHICA to include surveillance and screening algorithms for problematic infant night wakings. While an eventual aim is to create and test specific management tools for addressing sleep problems, aims of the current study focus on 1) testing items for the identification of sleep disruption, and 2) identifying current management practices in pediatric primary care.
All caregivers of children between the ages of 5 and 20 months presenting to one of five primary care health clinics will be randomly assigned to receive two of five items pertaining to sleep on the prescreening form (PSF) that is currently administered as part of standard clinical care. Parents will have the option to respond "yes" or "no." Regardless of their responses on the pre-screener form, each parent will then receive a form containing ten items from the Infant Sleep Questionnaire (ISQ). Two combinations of items that are similar (Items 1/2 and Items 3/4) will not be presented together, resulting in 8 possible arms or combinations of items.
If a child is identified as possibly having a sleep disturbance (e.g., caregiver answered yes to one or two items), CHICA will prominently display this information on the physician worksheet, viewed during the office visit. The PCP will receive feedback (e.g, "CHILD NAME may have problematic night wakings") via the electronic health record. At this time, providers will not be given additional guidance about how to proceed. At the end of the visit, the provider will be asked to indicate whether or not a sleep problem was confirmed based on their clinical judgment.
A sub-sample of caregivers whose primary care provider (PCP) confirmed a sleep problem will be contacted by phone within two weeks of the clinic visit and asked to complete an exit interview. Caregivers will be asked questions about their child's sleep, the content of the visit with their pediatrician that day (e.g., what the pediatrician recommended), their perceptions of those recommendations, and the outcome of those recommendations if they attempted them. Exit interviews will be conducted on an on-going basis until a sample of 100 has been completed. Up to 600 families may be contacted in order to complete 100 interviews.
Collaborators on this study include the following individuals:
Stephen Downs, MD, Indiana University School of Medicine; Tamara Dugan MS, Indiana University School of Medicine; Amy Schwichtenberg, PhD, Purdue University; and Jodi Mindell, PhD; St. Joseph's University
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Items1;3 | Experimental | Other: Item1, Other: Item3Caregiver is randomly assigned to receive screening items 1 and 3. Item 1: Does CHILD NAME often wake one or more times during the night? Item 3: Do you think CHILD NAME's sleep is a problem? |
| Items1;4 | Experimental | Other: Item1, Other: Item4Caregiver is randomly assigned to receive screening items 1 and 4. Item 1: Does CHILD NAME often wake one or more times during the night? Item 4: Does you think CHILD NAME has a sleep problem? |
| Items1;5 | Experimental | Other: Item1, Other: Item5Caregiver is randomly assigned to receive screening items 1 and 5. Item 1: Does CHILD NAME often wake one or more times during the night? Item 5: Do you have any concerns about CHILD NAME's sleep? |
| Items2;3 | Experimental | Other: Item2, Other: Item3Caregiver is randomly assigned to receive screening items 2 and 3. Item 2: Does CHILD NAME often wake one or more times per night and does an adult go to him/her? Item 3: Do you think CHILD NAME's sleep is a problem? |
| Items2;4 | Experimental | Other: Item2, Other: Item4Caregiver is randomly assigned to receive screening items 2 and 4. Item 2: Does CHILD NAME often wake one or more times per night and does an adult go to him/her? Item 4: Does you think CHILD NAME has a sleep problem? |
| Items2;5 | Experimental | Other: Item2, Other: Item5Caregiver is randomly assigned to receive screening items 2 and 5. Item 2: Does CHILD NAME often wake one or more times per night and does an adult go to him/her? Item 5: Do you have any concerns about CHILD NAME's sleep? |
| Items3;5 | Experimental | Other: Item3, Other: Item5Caregiver is randomly assigned to receive screening items 3 and 5. Item 3: Do you think CHILD NAME's sleep is a problem? Item 5: Do you have any concerns about CHILD NAME's sleep? |
| Items4;5 | Experimental | Other: Item4, Other: Item5Caregiver is randomly assigned to receive screening items 4 and 5. Item 4: Does you think CHILD NAME has a sleep problem? Item 5: Do you have any concerns about CHILD NAME's sleep? |
Who may qualify
- Ages
- 5 to 20 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Infant between the ages of 5 and 20 months (at the time of the visit)
- Caregiver responds to questions on the prescreening form in the waiting room
- Infant is a patient at one of five participating primary care health clinics in Indianapolis Indiana.
- For participation in the phone interviews, caregiver speaks English.
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Item1Does CHILD NAME often wake one or more times during the night? | Other | Items1;3, Items1;4, Items1;5 |
| Item2Does CHILD NAME often wake one or more times per night, and does and adult go to him/her? | Other | Items2;3, Items2;4, Items2;5 |
| Item3Do you think CHILD'S SLEEP is a problem? | Other | Items1;3, Items2;3, Items3;5 |
| Item4Do you think CHILD NAME has a sleep problem? | Other | Items1;4, Items2;4, Items4;5 |
| Item5Do you have any concerns about CHILD NAME'S sleep? | Other | Items1;5, Items2;5, Items3;5, Items4;5 |
Primary outcome
Problematic infant night wakings (per validated questionnaire)
Time frame: On the day of each visit to the PCP for the duration of the study (18 months) or until patient no longer meets eligibility (e.g. ages out).
Identifying the individual item or combination of two items that most strongly predict a positive score on the Infant Sleep Questionnaire
2 secondary outcomes
Problematic infant night wakings (per provider clinical judgment)
Time frame: On the day of each visit to the PCP for the duration of the study (18 months) or until patient no longer meets eligibility (e.g. ages out).
Night wakings management (per caregiver report)
Time frame: Within two weeks after the visit to the primary care provider
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 22 Feb 2018.
- 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.
Sarah M Honaker, PhD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Item1, Item2 and Item3 in people with Insomnia and Night Wakings, run by Indiana University 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 1 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 22 Feb 2018. 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?
Problematic infant night wakings (per validated questionnaire) (time frame: On the day of each visit to the PCP for the duration of the study (18 months) or until patient no longer meets eligibility (e.g. ages out).). 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 22 Feb 2018.