Sleep DisturbanceNCT04536766
Impact of Bed Provision and Sleep Education
A study testing Enhanced Sleep Health Education and Beds for Kids Standard Program in people with Sleep Disturbance and Sleep Deprivation, run by Saint Joseph's University, Philadelphia at 1 site in United States.
Trial summary
Investigators will recruit up to 100 families (children aged 8-12 years and their primary caregivers) from the Philadelphia-area Beds for Kids charity program, which provides beds, bedding, and sleep education to lower-socioeconomic status (SES) children. Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Sleep Disturbance, Sleep Deprivation, Sleep
- What is being tested?
- Enhanced Sleep Health Education and Beds for Kids Standard Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Oct 2020to 1 Jul 2023
- 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 8 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Caregiver participant is the parent or legal guardian of the child participant.
- Caregiver/legal guardian is 18 years of age.
- Child between 8 and 12 years of age.
- English-speaking
Who cannot join
- Caregiver is not parent or legal guardian of child participant.
- Presence of a diagnosed child neurodevelopmental (e.g., autism spectrum disorder, Trisomy 21) or chronic medical condition (e.g., sickle cell disease, cancer) in which the disorder or treatment of the disorder impact sleep.
- Caregivers/guardians or subjects who, in the opinion of the Investigator, may be non- compliant with study schedules or procedures.
Trial locations and contacts
1 site in 1 country.
United States1 site
Saint Joseph's University
Philadelphia, Pennsylvania, 19131
About this study
Official title: Impact of Bed Provision and Enhanced Sleep Health Education on Sleep in Socio-economically Disadvantaged Children
Investigators will recruit up to 100 families (children aged 8-12 years and their primary caregivers) from the Philadelphia-area Beds for Kids charity program, which provides beds, bedding, and sleep education to lower-socioeconomic status (SES) children. The primary objective of this randomized controlled trial is to determine whether bed provision combined with provider-delivered sleep health education can improve sleep in children participating in the Beds for Kids program.
Read the detailed description
Insufficient and poor-quality sleep impacts more than half of school-aged children, and is associated with significant impairments in child neurocognitive, academic, behavioral, and physical health functioning. Lower socioeconomic status (SES) children are at increased risk for poor sleep. Compared to their higher-SES peers, lower-SES youth tend to obtain less sleep overall and experience worse sleep quality. Many children of lower-SES also may live in noisy or high-violence neighborhoods and in overcrowded homes that lack a child bed or other designated child sleep space. These environmental factors may perpetuate SES-related health disparities in child sleep duration, quality, and poor sleep health behaviors (i.e., bedroom electronics). Although there is a robust evidence-base for treating childhood sleep problems, there is a paucity of sleep intervention research focused on lower-SES children.
Beds for Kids is a Philadelphia-area program that is part of the larger volunteer organization, One House at a Time, that provides lower-SES children with beds, bedding, and a sleep education brochure. To qualify for program participation, youth must be: (1) between the ages of 2 and 20 years, (2) living without an individual bed (e.g., sleeping on the floor, on a sofa, or crowded into one bed with family members), and (3) living in a household whose income is at or below 100 percent of the United States poverty threshold. The program accepts referrals from area social service agencies in the greater Philadelphia area.
- Conditions
- Sleep Disturbance, Sleep Deprivation, Sleep, Insomnia
- Being tested
- Enhanced Sleep Health Education, Beds for Kids Standard Program
- Medical subject headings
- Parasomnias, Sleep Deprivation, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced Sleep Health EducationBehavioural
The intervention comprehensively addresses poor sleep health behaviors. Personalized sleep health education will be delivered in two telephone sessions by Beds for Kids staff members. Sleep health information will consist of the following evidence-based pediatric sleep health behaviors: ensuring adequate sleep duration, developing a family bedtime routine, keeping a regular sleep schedule, avoiding caffeine, and eliminating electronics in the bedroom and at bedtime. The enhanced sleep health intervention sessions will also include individualized problem-solving and tailoring to meet the family's needs. Personalization will be accomplished via direct questions to families during the education phone call related to their own barriers to achieving healthy sleep habits and goals for optimal sleep.
Beds for Kids Standard ProgramBehavioural
The Beds for Kids program provides beds, bedding, and written healthy sleep education to families living at or below 100% of the federal poverty line and without an individual child bed to sleep in.
| Study group | Role | What they receive |
|---|---|---|
| Enhanced Sleep Health Education | Experimental | 50 families will be randomly assigned to receive sleep health education delivered in two telephone sessions by Beds for Kids staff members, in addition to receiving the standard Beds for Kids program (bed, bedding, written sleep education materials). The first session will occur approximately 2-3 days before bed delivery. The second 15-20-minute session will occur approximately one week following bed delivery. Sleep health education training and supervision of Beds for Kids staff members will be provided by board-certified Behavioral Sleep Medicine providers. Sleep health information will be manualized and will consist of evidence-based pediatric sleep health behaviors: ensuring adequate sleep duration, developing a bedtime routine, keeping a regular sleep schedule, avoiding caffeine, and eliminating electronics in the bedroom and at bedtime. The enhanced sleep health intervention sessions will also include individualized problem-solving and tailoring to meet the family's needs. Receives: Behavioral: Enhanced Sleep Health Education |
| Beds for Kids Standard Program | Active comparator | 50 families will be randomly assigned to the standard Beds for Kids program, which includes a bed, bedding, and written sleep education materials. Receives: Behavioral: Beds for Kids Standard Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment acceptability: Treatment Evaluation Inventory-Short Form
Caregivers randomized to the enhanced sleep health education arm will complete the Treatment Evaluation Inventory-Short Form, a widely used measure of treatment acceptability that has been adapted for the purposes of the Beds for Kids intervention. Caregivers will complete an electronic survey with questions related to aspects of the intervention including perceived efficacy/helpfulness and acceptability of the intervention. Seven items will be rated on a 5-point Likert scale from 1 'strongly disagree' and to 5 'strongly agree' with total scores ranging from 1 to 35 (higher scores denoting higher acceptability). In addition, the percent of participants who indicate they "agree" or "strongly agree" for each of the 4 items (acceptability of measures) and 3 items (helpfulness) will be reported.
Measured: 2 months
Sleep health-related behaviors
The Pediatric Sleep Practices Questionnaire is a 7 item measure related to sleep health-related practices, including bedtime routine consistency, the use of electronics prior to bedtime, sleep schedule regularity, and parental presence at bedtime, resulting in three subscales: total sleep timing (range 0-4), total routines/consistency (range 0-6), and total sleep environment (range 0-6). Two additional subscales include technology usage before bed (range 0-4) and the child's need for someone to fall asleep with them (range 0-2). Total scores range from 0 to 22. Higher scores denote poorer sleep practices.
Measured: 2 months
Sleep outcomes
Children and their caregivers will report on child sleep disturbance and sleep-related impairments, using the reliable and valid Patient-Reported Outcomes Measurement Information System (PROMIS) self-and caregiver-proxy-report scales for pediatric sleep. To measure sleep disturbance, the PROMIS Parent Proxy Sleep Disturbance - Short Form 8a and the PROMIS Pediatric Sleep Disturbance - Short Form 8a will be completed. For the measurement of impairments of daily function related to lack of sleep, the PROMIS Parent Proxy Sleep-Related Impairment - Short Form 8a and the PROMIS Pediatric Sleep-Related Impairment - Short Form 8a will be completed.
Items on all four assessments are rated on a 5-point Likert scale from 1 'never' to 5 'always,' with total sum scores for each measure ranging from 1 to 40 (higher scores denoting greater sleep disturbance or impairment). Scores will be converted into normative-based T-scores.
Measured: 2 months
Secondary outcomes (1)
Family engagement
Family engagement will be based on percent completion of sleep education phone calls (possible range = 0-100%) for the intervention group.
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 posted3 Sep 2020
- Study start24 Oct 2020
- Primary completion1 Jul 2023
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Sleep DisturbanceStudies of the same condition, open and under way.
- 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
- Model description
- 100 Caregiver-child dyads (children ages 8-12 years) will be recruited from the Beds for Kids program.
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saint Joseph's University, Philadelphia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04536766
- Sponsor's protocol ID
- 2020-01
- Status last verified
- Apr 2023
- First submitted
- 16 Aug 2020
- Last updated
- 16 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Allen SL, Howlett MD, Coulombe JA, Corkum PV. ABCs of SLEEPING: A review of the evidence behind pediatric sleep practice recommendations. Sleep Med Rev. 2016 Oct;29:1-14. doi: 10.1016/j.smrv.2015.08.006. Epub 2015 Sep 1.
PubMed 26551999Astill RG, Van der Heijden KB, Van Ijzendoorn MH, Van Someren EJ. Sleep, cognition, and behavioral problems in school-age children: a century of research meta-analyzed. Psychol Bull. 2012 Nov;138(6):1109-38. doi: 10.1037/a0028204. Epub 2012 Apr 30.
PubMed 22545685Buxton OM, Chang AM, Spilsbury JC, Bos T, Emsellem H, Knutson KL. Sleep in the modern family: protective family routines for child and adolescent sleep. Sleep Health. 2015 May 1;1(1):15-27. doi: 10.1016/j.sleh.2014.12.002.
PubMed 26779564Bagley EJ, Kelly RJ, Buckhalt JA, El-Sheikh M. What keeps low-SES children from sleeping well: the role of presleep worries and sleep environment. Sleep Med. 2015 Apr;16(4):496-502. doi: 10.1016/j.sleep.2014.10.008. Epub 2014 Dec 16.
PubMed 25701537Dewald JF, Meijer AM, Oort FJ, Kerkhof GA, Bogels SM. The influence of sleep quality, sleep duration and sleepiness on school performance in children and adolescents: A meta-analytic review. Sleep Med Rev. 2010 Jun;14(3):179-89. doi: 10.1016/j.smrv.2009.10.004. Epub 2010 Jan 21.
PubMed 20093054El-Sheikh M, Bagley EJ, Keiley M, Elmore-Staton L, Chen E, Buckhalt JA. Economic adversity and children's sleep problems: multiple indicators and moderation of effects. Health Psychol. 2013 Aug;32(8):849-59. doi: 10.1037/a0030413. Epub 2012 Nov 12.
PubMed 23148451Forrest CB, Meltzer LJ, Marcus CL, de la Motte A, Kratchman A, Buysse DJ, Pilkonis PA, Becker BD, Bevans KB. Development and validation of the PROMIS Pediatric Sleep Disturbance and Sleep-Related Impairment item banks. Sleep. 2018 Jun 1;41(6). doi: 10.1093/sleep/zsy054.
PubMed 29546286Jarrin DC, McGrath JJ, Quon EC. Objective and subjective socioeconomic gradients exist for sleep in children and adolescents. Health Psychol. 2014 Mar;33(3):301-5. doi: 10.1037/a0032924. Epub 2013 Jun 3.
PubMed 23730721Kelley ML, Heffer RW, Gresham FM, Elliott SN. Development of a modified treatment evaluation inventory. Journal of Psychopathology and Behavioral Assessment. 1989;11(3):235-247.
Miller MA, Kruisbrink M, Wallace J, Ji C, Cappuccio FP. Sleep duration and incidence of obesity in infants, children, and adolescents: a systematic review and meta-analysis of prospective studies. Sleep. 2018 Apr 1;41(4). doi: 10.1093/sleep/zsy018.
PubMed 29401314Mindell JA, Sedmak R, Boyle JT, Butler R, Williamson AA. Sleep Well!: A Pilot Study of an Education Campaign to Improve Sleep of Socioeconomically Disadvantaged Children. J Clin Sleep Med. 2016 Dec 15;12(12):1593-1599. doi: 10.5664/jcsm.6338.
PubMed 27655459
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Bed Provision and Enhanced Sleep Health Education on Sleep in Socio-economically Disadvantaged Children
- ClinicalTrials.gov ID
- NCT04536766
- Acronym / sponsor ID
- 2020-01
- Conditions
- Sleep Disturbance, Sleep Deprivation, Sleep, Insomnia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Saint Joseph's University, PhiladelphiaUniversity, hospital or other
- Study start
- 24 Oct 2020 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 3 Sep 2020 (actual)
- 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.
Investigators will recruit up to 100 families (children aged 8-12 years and their primary caregivers) from the Philadelphia-area Beds for Kids charity program, which provides beds, bedding, and sleep education to lower-socioeconomic status (SES) children. The primary objective of this randomized controlled trial is to determine whether bed provision combined with provider-delivered sleep health education can improve sleep in children participating in the Beds for Kids program.
Detailed description
Insufficient and poor-quality sleep impacts more than half of school-aged children, and is associated with significant impairments in child neurocognitive, academic, behavioral, and physical health functioning. Lower socioeconomic status (SES) children are at increased risk for poor sleep. Compared to their higher-SES peers, lower-SES youth tend to obtain less sleep overall and experience worse sleep quality. Many children of lower-SES also may live in noisy or high-violence neighborhoods and in overcrowded homes that lack a child bed or other designated child sleep space. These environmental factors may perpetuate SES-related health disparities in child sleep duration, quality, and poor sleep health behaviors (i.e., bedroom electronics). Although there is a robust evidence-base for treating childhood sleep problems, there is a paucity of sleep intervention research focused on lower-SES children.
Beds for Kids is a Philadelphia-area program that is part of the larger volunteer organization, One House at a Time, that provides lower-SES children with beds, bedding, and a sleep education brochure. To qualify for program participation, youth must be: (1) between the ages of 2 and 20 years, (2) living without an individual bed (e.g., sleeping on the floor, on a sofa, or crowded into one bed with family members), and (3) living in a household whose income is at or below 100 percent of the United States poverty threshold. The program accepts referrals from area social service agencies in the greater Philadelphia area.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 100 Caregiver-child dyads (children ages 8-12 years) will be recruited from the Beds for Kids program.
| Arm | Type | Receives |
|---|---|---|
| Enhanced Sleep Health Education | Experimental | Behavioral: Enhanced Sleep Health Education50 families will be randomly assigned to receive sleep health education delivered in two telephone sessions by Beds for Kids staff members, in addition to receiving the standard Beds for Kids program (bed, bedding, written sleep education materials). The first session will occur approximately 2-3 days before bed delivery. The second 15-20-minute session will occur approximately one week following bed delivery. Sleep health education training and supervision of Beds for Kids staff members will be provided by board-certified Behavioral Sleep Medicine providers. Sleep health information will be manualized and will consist of evidence-based pediatric sleep health behaviors: ensuring adequate sleep duration, developing a bedtime routine, keeping a regular sleep schedule, avoiding caffeine, and eliminating electronics in the bedroom and at bedtime. The enhanced sleep health intervention sessions will also include individualized problem-solving and tailoring to meet the family's needs. |
| Beds for Kids Standard Program | Active comparator | Behavioral: Beds for Kids Standard Program50 families will be randomly assigned to the standard Beds for Kids program, which includes a bed, bedding, and written sleep education materials. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Caregiver participant is the parent or legal guardian of the child participant.
- Caregiver/legal guardian is 18 years of age.
- Child between 8 and 12 years of age.
- English-speaking
Key exclusion criteria (3 listed)
- Caregiver is not parent or legal guardian of child participant.
- Presence of a diagnosed child neurodevelopmental (e.g., autism spectrum disorder, Trisomy 21) or chronic medical condition (e.g., sickle cell disease, cancer) in which the disorder or treatment of the disorder impact sleep.
- Caregivers/guardians or subjects who, in the opinion of the Investigator, may be non- compliant with study schedules or procedures.
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 |
|---|---|---|
| Enhanced Sleep Health EducationThe intervention comprehensively addresses poor sleep health behaviors. Personalized sleep health education will be delivered in two telephone sessions by Beds for Kids staff members. Sleep health information will consist of the following evidence-based pediatric sleep health behaviors: ensuring adequate sleep duration, developing a family bedtime routine, keeping a regular sleep schedule, avoiding caffeine, and eliminating electronics in the bedroom and at bedtime. The enhanced sleep health intervention sessions will also include individualized problem-solving and tailoring to meet the family's needs. Personalization will be accomplished via direct questions to families during the education phone call related to their own barriers to achieving healthy sleep habits and goals for optimal sleep. | Behavioural | Enhanced Sleep Health Education |
| Beds for Kids Standard ProgramThe Beds for Kids program provides beds, bedding, and written healthy sleep education to families living at or below 100% of the federal poverty line and without an individual child bed to sleep in. | Behavioural | Beds for Kids Standard Program |
Primary outcome
Treatment acceptability: Treatment Evaluation Inventory-Short Form
Time frame: 2 months
Caregivers randomized to the enhanced sleep health education arm will complete the Treatment Evaluation Inventory-Short Form, a widely used measure of treatment acceptability that has been adapted for the purposes of the Beds for Kids intervention. Caregivers will complete an electronic survey with questions related to aspects of the intervention including perceived efficacy/helpfulness and acceptability of the intervention. Seven items will be rated on a 5-point Likert scale from 1 'strongly disagree' and to 5 'strongly agree' with total scores ranging from 1 to 35 (higher scores denoting higher acceptability). In addition, the percent of participants who indicate they "agree" or "strongly agree" for each of the 4 items (acceptability of measures) and 3 items (helpfulness) will be reported.
Sleep health-related behaviors
Time frame: 2 months
The Pediatric Sleep Practices Questionnaire is a 7 item measure related to sleep health-related practices, including bedtime routine consistency, the use of electronics prior to bedtime, sleep schedule regularity, and parental presence at bedtime, resulting in three subscales: total sleep timing (range 0-4), total routines/consistency (range 0-6), and total sleep environment (range 0-6). Two additional subscales include technology usage before bed (range 0-4) and the child's need for someone to fall asleep with them (range 0-2). Total scores range from 0 to 22. Higher scores denote poorer sleep practices.
Sleep outcomes
Time frame: 2 months
Children and their caregivers will report on child sleep disturbance and sleep-related impairments, using the reliable and valid Patient-Reported Outcomes Measurement Information System (PROMIS) self-and caregiver-proxy-report scales for pediatric sleep. To measure sleep disturbance, the PROMIS Parent Proxy Sleep Disturbance - Short Form 8a and the PROMIS Pediatric Sleep Disturbance - Short Form 8a will be completed. For the measurement of impairments of daily function related to lack of sleep, the PROMIS Parent Proxy Sleep-Related Impairment - Short Form 8a and the PROMIS Pediatric Sleep-Related Impairment - Short Form 8a will be completed. Items on all four assessments are rated on a 5-point Likert scale from 1 'never' to 5 'always,' with total sum scores for each measure ranging from 1 to 40 (higher scores denoting greater sleep disturbance or impairment). Scores will be converted into normative-based T-scores.
1 secondary outcome
Family engagement
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 16 Apr 2024.
- Background: PubMed 26551999Allen SL, Howlett MD, Coulombe JA, Corkum PV. ABCs of SLEEPING: A review of the evidence behind pediatric sleep practice recommendations. Sleep Med Rev. 2016 Oct;29:1-14. doi: 10.1016/j.smrv.2015.08.006. Epub 2015 Sep 1.
- Background: PubMed 22545685Astill RG, Van der Heijden KB, Van Ijzendoorn MH, Van Someren EJ. Sleep, cognition, and behavioral problems in school-age children: a century of research meta-analyzed. Psychol Bull. 2012 Nov;138(6):1109-38. doi: 10.1037/a0028204. Epub 2012 Apr 30.
- Background: PubMed 26779564Buxton OM, Chang AM, Spilsbury JC, Bos T, Emsellem H, Knutson KL. Sleep in the modern family: protective family routines for child and adolescent sleep. Sleep Health. 2015 May 1;1(1):15-27. doi: 10.1016/j.sleh.2014.12.002.
- Background: PubMed 25701537Bagley EJ, Kelly RJ, Buckhalt JA, El-Sheikh M. What keeps low-SES children from sleeping well: the role of presleep worries and sleep environment. Sleep Med. 2015 Apr;16(4):496-502. doi: 10.1016/j.sleep.2014.10.008. Epub 2014 Dec 16.
- Background: PubMed 20093054Dewald JF, Meijer AM, Oort FJ, Kerkhof GA, Bogels SM. The influence of sleep quality, sleep duration and sleepiness on school performance in children and adolescents: A meta-analytic review. Sleep Med Rev. 2010 Jun;14(3):179-89. doi: 10.1016/j.smrv.2009.10.004. Epub 2010 Jan 21.
- Background: PubMed 23148451El-Sheikh M, Bagley EJ, Keiley M, Elmore-Staton L, Chen E, Buckhalt JA. Economic adversity and children's sleep problems: multiple indicators and moderation of effects. Health Psychol. 2013 Aug;32(8):849-59. doi: 10.1037/a0030413. Epub 2012 Nov 12.
- Background: PubMed 29546286Forrest CB, Meltzer LJ, Marcus CL, de la Motte A, Kratchman A, Buysse DJ, Pilkonis PA, Becker BD, Bevans KB. Development and validation of the PROMIS Pediatric Sleep Disturbance and Sleep-Related Impairment item banks. Sleep. 2018 Jun 1;41(6). doi: 10.1093/sleep/zsy054.
- Background: PubMed 23730721Jarrin DC, McGrath JJ, Quon EC. Objective and subjective socioeconomic gradients exist for sleep in children and adolescents. Health Psychol. 2014 Mar;33(3):301-5. doi: 10.1037/a0032924. Epub 2013 Jun 3.
- BackgroundKelley ML, Heffer RW, Gresham FM, Elliott SN. Development of a modified treatment evaluation inventory. Journal of Psychopathology and Behavioral Assessment. 1989;11(3):235-247.
- Background: PubMed 29401314Miller MA, Kruisbrink M, Wallace J, Ji C, Cappuccio FP. Sleep duration and incidence of obesity in infants, children, and adolescents: a systematic review and meta-analysis of prospective studies. Sleep. 2018 Apr 1;41(4). doi: 10.1093/sleep/zsy018.
- Background: PubMed 27655459Mindell JA, Sedmak R, Boyle JT, Butler R, Williamson AA. Sleep Well!: A Pilot Study of an Education Campaign to Improve Sleep of Socioeconomically Disadvantaged Children. J Clin Sleep Med. 2016 Dec 15;12(12):1593-1599. doi: 10.5664/jcsm.6338.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced Sleep Health Education and Beds for Kids Standard Program in people with Sleep Disturbance and Sleep Deprivation, run by Saint Joseph's University, Philadelphia 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 3 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 16 Apr 2024. 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?
Treatment acceptability: Treatment Evaluation Inventory-Short Form (time frame: 2 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?
On the ClinicalTrials.gov record for NCT04536766, which also lists 11 linked publications.
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 16 Apr 2024.