Sleep Initiation and Maintenance DisordersSHIPNCT02255721
Sleep Health in Preschoolers: a Randomized Controlled Trial
A study testing SHIP (Sleep Health in Preschoolers) in people with Sleep Initiation and Maintenance Disorders, run by Seattle Children's Hospital at 1 site in United States.
Trial summary
The SHIP study is a randomized controlled trial of an intervention for preschool children with sleep problems, in which we aim to give parents the knowledge, motivation, and skills necessary to set goals, problem-solve, and improve their child's sleep. Read more about this study
- Who is it for?
- Ages 30 to 71 months
- Conditions the study is for
- Sleep Initiation and Maintenance Disorders
- What is being tested?
- SHIP (Sleep Health in Preschoolers)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to Dec 2020
- 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 30 to 71 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 30-71 months
- Child behavioral sleep problem, as demonstrated by a score on the Children's Sleep Habits Questionnaire (CSHQ) of at least 50, or a score of 41-49 and reported weeknight sleep of 9hrs or less per night
- English speaking parent or guardian
Who cannot join
- Sleep disordered breathing, as demonstrated by a score on the CSHQ of at least 5
- Currently taking prescribed sleep medications, psychostimulants, and/or systemic corticosteroids
- Serious medical conditions likely to affect sleep, including diabetes or cancer
- Major cognitive or developmental disorder, including autism spectrum disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
Seattle Children's Research Institute
Seattle, Washington, 98145-5005
About this study
Official title: Healthy Sleep Intervention For Preschool Children: A Randomized Controlled Trial of the SHIP Intervention
The SHIP study is a randomized controlled trial of an intervention for preschool children with sleep problems, in which we aim to give parents the knowledge, motivation, and skills necessary to set goals, problem-solve, and improve their child's sleep. In collecting three years of follow-up data, we will be able to determine the impact of the SHIP intervention on childhood sleep problems, obesity, academic achievement, and emotional and behavioral problems, as well as parental stress and daytime tiredness. This study has the dual potential to expand treatment resources for young children with behavioral sleep problems and to increase our scientific understanding of the long-term consequences of early childhood sleep problems.
- Being tested
- SHIP (Sleep Health in Preschoolers), SHIP Control Arm
- 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.
SHIP (Sleep Health in Preschoolers)Behavioural
SHIP (Sleep Health in Preschoolers) is a family-centered health behavior change intervention for child behavioral sleep problems delivered 1:1 to parents via a home visit and follow-up phone calls.
SHIP Control ArmBehavioural
Families will receive a family-centered health behavior change intervention for child health topics unrelated to sleep or outcome measures, delivered 1:1 to parents via a home visit and follow-up phone calls.
| Study group | Role | What they receive |
|---|---|---|
| SHIP Intervention | Experimental | SHIP is a health behavior change intervention to give parents the knowledge, motivation, and skills necessary to set goals, problem-solve, and improve their child's sleep. Receives: Behavioral: SHIP (Sleep Health in Preschoolers) |
| SHIP Control Arm | Active comparator | The active control arm uses the same strategies as the SHIP intervention arm, but for child health topics unrelated to sleep or outcome measures. Receives: Behavioral: SHIP Control Arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in actigraphic and diary measured sleep quantity and quality measures
Change in actigraphic and diary measured sleep quantity (total sleep time, nocturnal sleep time) and quality (percent wake after sleep onset) measures
Measured: Baseline, 3-month follow-up
Change in actigraphic and diary measured sleep quantity and quality measures
Change in actigraphic and diary measured sleep quantity (total sleep time, nocturnal sleep time) and quality (percent wake after sleep onset) measures
Measured: Baseline, 12-month follow-up
Change in actigraphic and diary measured sleep quantity and quality measures
Change in actigraphic and diary measured sleep quantity (total sleep time, nocturnal sleep time) and quality (percent wake after sleep onset) measure
Measured: Baseline, 24-month follow-up
Change in actigraphic and diary measured sleep quantity and quality measures
Change in actigraphic and diary measured sleep quantity (total sleep time, nocturnal sleep time) and quality (percent wake after sleep onset) measures
Measured: Baseline, 36-month follow-up
Change in actigraphic and parent report measures of sleep onset difficulties
Change in actigraphic and parent report measures of sleep onset difficulties (sleep onset latency, Child Sleep Wake Scale subscales for Going to Bed and Falling Asleep)
Measured: Baseline, 3-month follow-up
Change in actigraphic and parent report measures of sleep onset difficulties
Change in actigraphic and parent report measures of sleep onset difficulties (sleep onset latency, Child Sleep Wake Scale subscales for Going to Bed and Falling Asleep)
Measured: Baseline, 12-month follow-up
Change in actigraphic and parent report measures of sleep onset difficulties
Change in actigraphic and parent report measures of sleep onset difficulties (sleep onset latency, Child Sleep Wake Scale subscales for Going to Bed and Falling Asleep)
Measured: Baseline, 24-month follow-up
Change in actigraphic and parent report measures of sleep onset difficulties
Change in actigraphic and parent report measures of sleep onset difficulties (sleep onset latency, Child Sleep Wake Scale subscales for Going to Bed and Falling Asleep)
Measured: Baseline, 36-month follow-up
Secondary outcomes (12)
Change in child anthropometric measures
Change in child anthropometric measures (BMI z-score for age and gender, waist circumference)
Measured: Baseline, 24-month follow-up
Change in child anthropometric measures
Change in child anthropometric measures (BMI z-score for age and gender, waist circumference)
Measured: Baseline, 36-month follow-up
Trajectory in child anthropometric measures
Trajectory in child anthropometric measures (BMI z-score for age and gender, waist circumference)
Measured: Baseline, 12-month follow-up, 24-month follow-up, 36-month follow-up
Change in parent-reported child behavioral and emotional symptoms and executive function
Change in parent-reported child behavioral and emotional symptoms (CBCL subscores for anxious/depressed, attention, somatic complaints, and aggressive behavior) and executive function (BRIEF subscores for inhibit, shift, and emotional control)
Measured: Baseline, 3-month follow-up
Change in parent-reported child behavioral and emotional symptoms and executive function
Change in parent-reported child behavioral and emotional symptoms (CBCL subscores for anxious/depressed, attention, somatic complaints, and aggressive behavior) and executive function (BRIEF subscores for inhibit, shift, and emotional control)
Measured: Baseline, 12-month follow-up
Change in parent & teacher-reported child behavioral and emotional symptoms (CBCL subscores for anxious/depressed, attention, somatic complaints, and aggressive behavior) and executive function (BRIEF subscores for inhibit, shift, and emotional control)
Measured: Baseline, 24-month follow-up
Change in parent & teacher-reported child behavioral and emotional symptoms and executive function
Change in parent \& teacher-reported child behavioral and emotional symptoms (CBCL subscores for anxious/depressed, attention, somatic complaints, and aggressive behavior) and executive function (BRIEF subscores for inhibit, shift, and emotional control)
Measured: Baseline, 36-month follow-up
Change in directly assessed performance on WJIII NU achievement battery and executive function
Change in directly assessed performance on WJIII NU achievement battery (extended pre-academic battery plus oral language and basic reading skills) and executive function (iPad-based testing).
Measured: Baseline, 12-month follow-up
Change in directly assessed performance on WJIII NU achievement battery and executive function
Change in directly assessed performance on WJIII NU achievement battery (extended pre-academic battery plus oral language, basic reading skills, math, and written expression) and executive function (iPad-based testing)
Measured: Baseline, 24-month follow-up
Change in directly assessed performance on WJIII NU achievement battery and executive function
Change in directly assessed performance on WJIII NU achievement battery (extended pre-academic battery plus oral language, basic reading skills, math, and written expression) and executive function (iPad-based testing)
Measured: Baseline, 36-month follow-up
Trajectory in actigraphic and diary measured sleep quantity and quality measures
Trajectory in actigraphic and diary measured sleep quantity (total sleep time, nocturnal sleep time) and quality (percent wake after sleep onset) measures
Measured: Baseline, 3-month follow-up, 12-month follow-up, 24-month follow-up, 36-month follow-up
Trajectory in actigraphic and parent report measures of sleep onset difficulties
Trajectory in actigraphic and parent report measures of sleep onset difficulties (sleep onset latency, Child Sleep Wake Scale subscales for Going to Bed and Falling Asleep)
Measured: Baseline, 3-month follow-up, 12-month follow-up, 24-month follow-up, 36-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 posted2 Oct 2014 (estimated)
- Study startNov 2013
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Initiation and Maintenance DisordersStudies of the same condition, open and under way.
- More trials run by Seattle 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seattle Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Michelle Garrison, Seattle Children's Hospital
- Investigators
- Michelle Garrison, PhD, Principal investigator, Seattle Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02255721
- Sponsor's protocol ID
- 416530030101
- Other IDs
- R01HD071937
- Acronym
- SHIP
- Status last verified
- Aug 2020
- First submitted
- 30 Sep 2014
- Last updated
- 12 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthy Sleep Intervention For Preschool Children: A Randomized Controlled Trial of the SHIP Intervention
- ClinicalTrials.gov ID
- NCT02255721
- Acronym / sponsor ID
- SHIP / 416530030101
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Seattle Children's HospitalUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Nov 2013 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 2 Oct 2014 (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 SHIP study is a randomized controlled trial of an intervention for preschool children with sleep problems, in which we aim to give parents the knowledge, motivation, and skills necessary to set goals, problem-solve, and improve their child's sleep. In collecting three years of follow-up data, we will be able to determine the impact of the SHIP intervention on childhood sleep problems, obesity, academic achievement, and emotional and behavioral problems, as well as parental stress and daytime tiredness. This study has the dual potential to expand treatment resources for young children with behavioral sleep problems and to increase our scientific understanding of the long-term consequences of early childhood sleep problems.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SHIP Intervention | Experimental | Behavioral: SHIP (Sleep Health in Preschoolers)SHIP is a health behavior change intervention to give parents the knowledge, motivation, and skills necessary to set goals, problem-solve, and improve their child's sleep. |
| SHIP Control Arm | Active comparator | Behavioral: SHIP Control ArmThe active control arm uses the same strategies as the SHIP intervention arm, but for child health topics unrelated to sleep or outcome measures. |
Who may qualify
- Ages
- 30 to 71 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age 30-71 months
- Child behavioral sleep problem, as demonstrated by a score on the Children's Sleep Habits Questionnaire (CSHQ) of at least 50, or a score of 41-49 and reported weeknight sleep of 9hrs or less per night
- English speaking parent or guardian
Key exclusion criteria (4 listed)
- Sleep disordered breathing, as demonstrated by a score on the CSHQ of at least 5
- Currently taking prescribed sleep medications, psychostimulants, and/or systemic corticosteroids
- Serious medical conditions likely to affect sleep, including diabetes or cancer
- Major cognitive or developmental disorder, including autism spectrum disorder
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 |
|---|---|---|
| SHIP (Sleep Health in Preschoolers)SHIP (Sleep Health in Preschoolers) is a family-centered health behavior change intervention for child behavioral sleep problems delivered 1:1 to parents via a home visit and follow-up phone calls. | Behavioural | SHIP Intervention |
| SHIP Control ArmFamilies will receive a family-centered health behavior change intervention for child health topics unrelated to sleep or outcome measures, delivered 1:1 to parents via a home visit and follow-up phone calls. | Behavioural | SHIP Control Arm |
Primary outcome
Change in actigraphic and diary measured sleep quantity and quality measures
Time frame: Baseline, 3-month follow-up
Change in actigraphic and diary measured sleep quantity (total sleep time, nocturnal sleep time) and quality (percent wake after sleep onset) measures
Change in actigraphic and diary measured sleep quantity and quality measures
Time frame: Baseline, 12-month follow-up
Change in actigraphic and diary measured sleep quantity (total sleep time, nocturnal sleep time) and quality (percent wake after sleep onset) measures
Change in actigraphic and diary measured sleep quantity and quality measures
Time frame: Baseline, 24-month follow-up
Change in actigraphic and diary measured sleep quantity (total sleep time, nocturnal sleep time) and quality (percent wake after sleep onset) measure
Change in actigraphic and diary measured sleep quantity and quality measures
Time frame: Baseline, 36-month follow-up
Change in actigraphic and diary measured sleep quantity (total sleep time, nocturnal sleep time) and quality (percent wake after sleep onset) measures
Change in actigraphic and parent report measures of sleep onset difficulties
Time frame: Baseline, 3-month follow-up
Change in actigraphic and parent report measures of sleep onset difficulties (sleep onset latency, Child Sleep Wake Scale subscales for Going to Bed and Falling Asleep)
Change in actigraphic and parent report measures of sleep onset difficulties
Time frame: Baseline, 12-month follow-up
Change in actigraphic and parent report measures of sleep onset difficulties (sleep onset latency, Child Sleep Wake Scale subscales for Going to Bed and Falling Asleep)
Change in actigraphic and parent report measures of sleep onset difficulties
Time frame: Baseline, 24-month follow-up
Change in actigraphic and parent report measures of sleep onset difficulties (sleep onset latency, Child Sleep Wake Scale subscales for Going to Bed and Falling Asleep)
Change in actigraphic and parent report measures of sleep onset difficulties
Time frame: Baseline, 36-month follow-up
Change in actigraphic and parent report measures of sleep onset difficulties (sleep onset latency, Child Sleep Wake Scale subscales for Going to Bed and Falling Asleep)
12 secondary outcomes
Change in child anthropometric measures
Time frame: Baseline, 24-month follow-up
Change in child anthropometric measures
Time frame: Baseline, 36-month follow-up
Trajectory in child anthropometric measures
Time frame: Baseline, 12-month follow-up, 24-month follow-up, 36-month follow-up
Change in parent-reported child behavioral and emotional symptoms and executive function
Time frame: Baseline, 3-month follow-up
Change in parent-reported child behavioral and emotional symptoms and executive function
Time frame: Baseline, 12-month follow-up
Change in parent & teacher-reported child behavioral and emotional symptoms (CBCL subscores for anxious/depressed, attention, somatic complaints, and aggressive behavior) and executive function (BRIEF subscores for inhibit, shift, and emotional control)
Time frame: Baseline, 24-month follow-up
Change in parent & teacher-reported child behavioral and emotional symptoms and executive function
Time frame: Baseline, 36-month follow-up
Change in directly assessed performance on WJIII NU achievement battery and executive function
Time frame: Baseline, 12-month follow-up
Change in directly assessed performance on WJIII NU achievement battery and executive function
Time frame: Baseline, 24-month follow-up
Change in directly assessed performance on WJIII NU achievement battery and executive function
Time frame: Baseline, 36-month follow-up
Trajectory in actigraphic and diary measured sleep quantity and quality measures
Time frame: Baseline, 3-month follow-up, 12-month follow-up, 24-month follow-up, 36-month follow-up
Trajectory in actigraphic and parent report measures of sleep onset difficulties
Time frame: Baseline, 3-month follow-up, 12-month follow-up, 24-month follow-up, 36-month follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2020.
Related trials for Sleep Initiation and Maintenance Disorders
Recruiting
Addressing Nocturia in Older Women Utilizing Behavioral Sleep Intervention and Brief Mindfulness
Nocturia, Insomnia
Not yet recruiting
A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders
Recruiting
Effect of Cyclic Sighing Breathing Exercise on CRBD, Pain, and Sleep Quality in Patients Undergoing TUR
Transurethral Resection of Bladder Tumor, Transurethral Resection of the Prostate (TURP)
Recruiting
Treating Insomnia in Mild Cognitive Impairment
Mild Cognitive Impairment (MCI), Insomnia
RecruitingPhase 4
The Effects of Orexin Antagonism on Fear Extinction in PTSD
Insomnia, PTSD
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.
Michelle Garrison, PhD principal investigator
Seattle 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 study testing SHIP (Sleep Health in Preschoolers) in people with Sleep Initiation and Maintenance Disorders, run by Seattle 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 3 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: status not confirmed, as of the sponsor's last update on 12 Aug 2020. 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?
Results are not available in the source record.
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?
Change in actigraphic and diary measured sleep quantity and quality measures (time frame: Baseline, 3-month follow-up). The study lists 8 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 12 Aug 2020.