Down SyndromeNCT02996175
Treatment of Sleep Disturbances in School-age Children With Down Syndrome
A study testing Behavioral Sleep Treatment in people with Down Syndrome, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
The investigators long-term goal is to improve outcomes for children with Down syndrome (DS) and their caregivers. Towards that goal, the investigators propose a randomized clinical trial of a behavioral sleep treatment designed specifically for children with DS, documenting the impact not only on sleep, but also on… Read more about this study
- Who is it for?
- Ages 6 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Down Syndrome
- What is being tested?
- Behavioral Sleep Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to May 2018
- 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 6 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- diagnosis of Down Syndrome
- 6-17 years of age
- behavioral sleep problem (presence of 5 or more nights a week of: bedtime resistance, delayed sleep onset, problematic sleep associations, nighttime awakenings or morning awakenings)
- English as primary language
Who cannot join
- past diagnosis of Pervasive Developmental Disorder-Not Otherwise Specified/Autism Spectrum Disorder
- History of blindness,deafness,motor impairment
- nonverbal mental age below 36 months
- any medication change w/in past 2 months affecting sleep
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
The investigators long-term goal is to improve outcomes for children with Down syndrome (DS) and their caregivers. Towards that goal, the investigators propose a randomized clinical trial of a behavioral sleep treatment designed specifically for children with DS, documenting the impact not only on sleep, but also on the child's daytime inhibitory control and behavior problems, and the caregiver's sleep and stress levels. The investigators will randomize 80 families of children with DS ages 6-17 to receive either a 5-session behavioral sleep treatment (BST; targeting sleep education, behavioral principles and visual supports) or a general-education control condition (CON). The BST will cater to the unique needs of children with DS, adapting an intervention that successfully treats behavioral sleep disturbances in children with autism1. Pre- and post-intervention, children will undergo comprehensive assessments of cognitive, behavioral, and adaptive functioning involving direct testing and input from parents and teachers. Child and parent sleep will be monitored via actigraphy and parent-completed sleep diaries, and parents will report on their stress levels and mood.
Read the detailed description
The investigators long-term goal is to improve outcomes for children with DS and their caregivers. Towards that goal, the investigators propose a randomized clinical trial of a behavioral sleep treatment designed specifically for children with DS, documenting the impact not only on sleep, but also on the child's daytime inhibitory control and behavior problems, and the caregiver's sleep and stress levels. The investigators will randomize 80 families of children with DS ages 6-17 to receive either a 5-session behavioral sleep treatment (BST; targeting sleep education, behavioral principles and visual supports) or a general-education control condition (CON). The BST will catered to the unique needs of children with DS, adapting an intervention developed by a member of the investigators research team with NIH support (R34 MH082882) that successfully treats behavioral sleep disturbances in children with autism41. Pre- and post-intervention, children will undergo comprehensive assessments of cognitive, behavioral, and adaptive functioning involving direct testing and input from parents and teachers. Child and parent sleep will be monitored via actigraphy and parent-completed sleep diaries, and parents will report on their stress levels and mood. As a critical first step towards an effective treatment, this initial efficacy study will address 3 aims:
Aim #1: Test the efficacy of manualized BST for improving the sleep of children with DS.
Hypothesis 1: Sleep duration and quality will improve more in the BST condition than the CON condition.
Aim #2: Test the impact of the BST on the daytime functioning of children with DS.
Hypothesis 2: Children receiving BST will make greater gains in inhibitory control, general behavior problems and other measures of executive dysfunction than in the CON condition.
Aim #3: Test whether the BST, which focuses on the child's sleep, also impacts caregivers' sleep and stress.
Hypothesis 3: Parents of children receiving BST will have improved sleep duration and decreased stress.
- Conditions
- Down Syndrome
- Being tested
- Behavioral Sleep Treatment, Standard of care sleep treatment enhanced with psychoeducation
- Keywords
- Behavior, Sleep, Problems, Intervention
- Medical subject headings
- Down Syndrome, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral Sleep TreatmentBehavioural
- Introduction to the treatment program, an overview of common sleep problems in DS, and the basic principles of the behavioral approach as it relates to sleep problems
- Information on healthy sleep hygiene, preventative techniques, and use of visual supports
- Information on reinforcement and extinction procedures for bedtime struggles, codependence, night waking, early waking
- Information on procedures for delayed sleep onset and problematic sleep associations
- Feedback on implementation of behavioral sleep treatments and strategies for managing sleep hygiene in the future
Standard of care sleep treatment enhanced with psychoeducationBehavioural
- Introduction to the general-education program, build rapport with family, and review basic information on Down syndrome
- Introduction to understanding and interpreting results from clinical evaluations
- Introduction to educational planning, expectations, and transition planning
- Introduction to lifespan development and advocacy and support services available
- Feedback on current concerns and methods for obtaining services to manage concerns
| Study group | Role | What they receive |
|---|---|---|
| SMART | Experimental | Treatment group targeting behavioral sleep problems for 5 weeks.
1. Introduction to the treatment program, an overview of common sleep problems in DS, and the basic principles of the behavioral approach as it relates to sleep problems
2. Information on healthy sleep hygiene, preventative techniques, and use of visual supports
3. Information on reinforcement and extinction procedures for bedtime struggles, codependence, night waking, early waking
4. Information on procedures for delayed sleep onset and problematic sleep associations
5. Feedback on implementation of behavioral sleep treatments and strategies for managing sleep hygiene in the future Receives: Behavioral: Behavioral Sleep Treatment |
| WISE | Active comparator | Standard of care sleep treatment enhanced with psychoeducation. 1 Introduction to the general-education program, build rapport with family, and review basic information on Down syndrome 2 Introduction to understanding and interpreting results from clinical evaluations 3 Introduction to educational planning, expectations, and transition planning 4 Introduction to lifespan development and advocacy and support services available 5 Feedback on current concerns and methods for obtaining services to manage concerns Receives: Behavioral: Standard of care sleep treatment enhanced with psychoeducation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Longer child sleep duration as measured by actigraphy and Improved sleep quality for child measure by Children's Sleep Habits Questionnaire (CSHQ)
33-item Parent reported sleep quality for Child over past week. Each item is scored 1-3 (1 = Rarely, 0-1x/week; 2 = Sometimes, 2-4x/week; 3= Usually, 5-7x/week). There are 6 questions with reverse scoring. This will yield a total between 33 and 99.
This will be acquired from parent three times throughout study, data scored and entered into SPSS by coordinator using total score data for comparatives to actigraph results for total sleep.
Measured: Baseline, 6 Weeks, 19 Weeks
Secondary outcomes (2)
Improved child behaviors as measured by parent report on Child Behavior Checklist (CBCL)
113-Item parent report measure for child behavior now. Each item is scored 0-2 (0 = Not True (as far as you know); 1 = Somewhat or Sometimes True; 2 = Very True or Often True. Scoring is done through software giving T-scores for 8 subscales with borderline and clinical ranges identified. SPSS will be used for analysis to compare to parent report data from a daily behavior journal.
Measured: Baseline, 6 Weeks, 19 Weeks
Longer Parent sleep duration as measured by actigraphy and reduced parental stress as measured by the Family Impact Questionnaire (FIQ).
50-item parent report measure rating child's impact on family and different areas of family functioning. Each of the first 48 items are scored 1-4 (1 = Not at all; 2 = Somewhat; 3 = Much; 4 = Very Much) and items 48 \& 49 scored 1-7 (1 = Much Easier; 2 = Easier; 3 = Slightly Easier; 4 = About the Same; 5 = Slightly More Difficult; 6 = More Difficult; 7 = Much More Difficult). There are 5 items that are reverse scored. Scoring yields T-scores for 7 subscales.Data will be entered into SPSS and used as a parental stress scale for social impact.
Measured: Baseline, 6 Weeks, 19 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2016 (estimated)
- Study startJul 2015
- Primary completionMay 2018
- Study completionMay 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Down SyndromeStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe 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
- Investigator
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02996175
- Sponsor's protocol ID
- 1R21HD082307-01A1
- Status last verified
- Jun 2018
- First submitted
- 30 Nov 2015
- Last updated
- 4 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Sleep Disturbances in School-age Children With Down Syndrome
- ClinicalTrials.gov ID
- NCT02996175
- Acronym / sponsor ID
- 1R21HD082307-01A1
- Conditions
- Down Syndrome
- Keywords
- Behavior, Sleep, Problems, Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- May 2018 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 19 Dec 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.
The investigators long-term goal is to improve outcomes for children with Down syndrome (DS) and their caregivers. Towards that goal, the investigators propose a randomized clinical trial of a behavioral sleep treatment designed specifically for children with DS, documenting the impact not only on sleep, but also on the child's daytime inhibitory control and behavior problems, and the caregiver's sleep and stress levels. The investigators will randomize 80 families of children with DS ages 6-17 to receive either a 5-session behavioral sleep treatment (BST; targeting sleep education, behavioral principles and visual supports) or a general-education control condition (CON). The BST will cater to the unique needs of children with DS, adapting an intervention that successfully treats behavioral sleep disturbances in children with autism1. Pre- and post-intervention, children will undergo comprehensive assessments of cognitive, behavioral, and adaptive functioning involving direct testing and input from parents and teachers. Child and parent sleep will be monitored via actigraphy and parent-completed sleep diaries, and parents will report on their stress levels and mood.
Detailed description
The investigators long-term goal is to improve outcomes for children with DS and their caregivers. Towards that goal, the investigators propose a randomized clinical trial of a behavioral sleep treatment designed specifically for children with DS, documenting the impact not only on sleep, but also on the child's daytime inhibitory control and behavior problems, and the caregiver's sleep and stress levels. The investigators will randomize 80 families of children with DS ages 6-17 to receive either a 5-session behavioral sleep treatment (BST; targeting sleep education, behavioral principles and visual supports) or a general-education control condition (CON). The BST will catered to the unique needs of children with DS, adapting an intervention developed by a member of the investigators research team with NIH support (R34 MH082882) that successfully treats behavioral sleep disturbances in children with autism41. Pre- and post-intervention, children will undergo comprehensive assessments of cognitive, behavioral, and adaptive functioning involving direct testing and input from parents and teachers. Child and parent sleep will be monitored via actigraphy and parent-completed sleep diaries, and parents will report on their stress levels and mood. As a critical first step towards an effective treatment, this initial efficacy study will address 3 aims:
Aim #1: Test the efficacy of manualized BST for improving the sleep of children with DS.
Hypothesis 1: Sleep duration and quality will improve more in the BST condition than the CON condition.
Aim #2: Test the impact of the BST on the daytime functioning of children with DS.
Hypothesis 2: Children receiving BST will make greater gains in inhibitory control, general behavior problems and other measures of executive dysfunction than in the CON condition.
Aim #3: Test whether the BST, which focuses on the child's sleep, also impacts caregivers' sleep and stress.
Hypothesis 3: Parents of children receiving BST will have improved sleep duration and decreased stress.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SMART | Experimental | Behavioral: Behavioral Sleep TreatmentTreatment group targeting behavioral sleep problems for 5 weeks. 1. Introduction to the treatment program, an overview of common sleep problems in DS, and the basic principles of the behavioral approach as it relates to sleep problems 2. Information on healthy sleep hygiene, preventative techniques, and use of visual supports 3. Information on reinforcement and extinction procedures for bedtime struggles, codependence, night waking, early waking 4. Information on procedures for delayed sleep onset and problematic sleep associations 5. Feedback on implementation of behavioral sleep treatments and strategies for managing sleep hygiene in the future |
| WISE | Active comparator | Behavioral: Standard of care sleep treatment enhanced with psychoeducationStandard of care sleep treatment enhanced with psychoeducation. 1 Introduction to the general-education program, build rapport with family, and review basic information on Down syndrome 2 Introduction to understanding and interpreting results from clinical evaluations 3 Introduction to educational planning, expectations, and transition planning 4 Introduction to lifespan development and advocacy and support services available 5 Feedback on current concerns and methods for obtaining services to manage concerns |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- diagnosis of Down Syndrome
- 6-17 years of age
- behavioral sleep problem (presence of 5 or more nights a week of: bedtime resistance, delayed sleep onset, problematic sleep associations, nighttime awakenings or morning awakenings)
- English as primary language
Key exclusion criteria (4 listed)
- past diagnosis of Pervasive Developmental Disorder-Not Otherwise Specified/Autism Spectrum Disorder
- History of blindness,deafness,motor impairment
- nonverbal mental age below 36 months
- any medication change w/in past 2 months affecting sleep
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 |
|---|---|---|
| Behavioral Sleep Treatment1. Introduction to the treatment program, an overview of common sleep problems in DS, and the basic principles of the behavioral approach as it relates to sleep problems 2. Information on healthy sleep hygiene, preventative techniques, and use of visual supports 3. Information on reinforcement and extinction procedures for bedtime struggles, codependence, night waking, early waking 4. Information on procedures for delayed sleep onset and problematic sleep associations 5. Feedback on implementation of behavioral sleep treatments and strategies for managing sleep hygiene in the future | Behavioural | SMART |
| Standard of care sleep treatment enhanced with psychoeducation1. Introduction to the general-education program, build rapport with family, and review basic information on Down syndrome 2. Introduction to understanding and interpreting results from clinical evaluations 3. Introduction to educational planning, expectations, and transition planning 4. Introduction to lifespan development and advocacy and support services available 5. Feedback on current concerns and methods for obtaining services to manage concerns | Behavioural | WISE |
Primary outcome
Longer child sleep duration as measured by actigraphy and Improved sleep quality for child measure by Children's Sleep Habits Questionnaire (CSHQ)
Time frame: Baseline, 6 Weeks, 19 Weeks
33-item Parent reported sleep quality for Child over past week. Each item is scored 1-3 (1 = Rarely, 0-1x/week; 2 = Sometimes, 2-4x/week; 3= Usually, 5-7x/week). There are 6 questions with reverse scoring. This will yield a total between 33 and 99. This will be acquired from parent three times throughout study, data scored and entered into SPSS by coordinator using total score data for comparatives to actigraph results for total sleep.
2 secondary outcomes
Improved child behaviors as measured by parent report on Child Behavior Checklist (CBCL)
Time frame: Baseline, 6 Weeks, 19 Weeks
Longer Parent sleep duration as measured by actigraphy and reduced parental stress as measured by the Family Impact Questionnaire (FIQ).
Time frame: Baseline, 6 Weeks, 19 Weeks
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 4 Jun 2018.
Related trials for Down Syndrome
Not yet recruitingPhase 4
Oral Switch in Bloodstream Infections in Immunocompromised Children
Bloodstream Infection, Bloodstream Infection Due to Central Venous Catheter
Not yet recruiting
Fecal Microbiota Transplantation (FMT) to Slow Biological Aging
Aging, Healthy, Aging and Cognitive Health
Active, not recruitingPhase 3
A Study to Investigate Blinatumomab in Combination With Chemotherapy in Patients With Newly Diagnosed B-Lymphoblastic Leukemia
B Acute Lymphoblastic Leukemia, B Lymphoblastic Lymphoma
Not yet recruiting
Executive Function Play Opportunities for Children With Down Syndrome
Down Syndrome, Trisomy 21
RecruitingObservational study
Natural History of Dysregulation and Aging of the Immune System in People With Trisomy 21 With and Without Thymectomy
Down Syndrome
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 Behavioral Sleep Treatment in people with Down Syndrome, run by Children's Hospital Medical Center, Cincinnati 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 4 Jun 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?
Longer child sleep duration as measured by actigraphy and Improved sleep quality for child measure by Children's Sleep Habits Questionnaire (CSHQ) (time frame: Baseline, 6 Weeks, 19 Weeks). 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 4 Jun 2018.