Attention Deficit Hyperactivity DisorderPhase 1/2NCT00867451
Improving Sleep and Daytime Functioning Among Children Diagnosed With Attention Deficit Hyperactivity Disorder (ADHD)
A Phase 1/2 study testing Sleep Intervention and Melatonin in people with Attention Deficit Hyperactivity Disorder, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
This study will test the efficacy of a systematic, multi-modal intervention protocol designed to improve sleep functioning and subsequent alleviation of daytime cognitive and behavioral difficulties among children diagnosed with ADHD. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- Sleep Intervention and Melatonin
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Jul 2011
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Consent: The family must provide signature of informed consent by parents or legal guardians
- Assent: Children must provide assent to participate in the study (via signature on assent form)
- Age at time of Screening: 6 years to 12 years, inclusive
- Gender: includes male and female children.
- ADHD Diagnostic Status: The primary criterion is that patients must meet DSM-IV criteria for ADHD.
- Presence of Significant Sleep Problems: Assessed through clinical history and a commonly used parent-report of children's sleep habits. A cut-off score of or greater than 41 on the Children's Sleep Habits Questionnaire (CSHQ) will be used.
- Functioning at appropriate grade level for age.
Who cannot join
- Understanding Level: The parent is not fluent in the language of the wording used in the consent form.
- Exclusionary Psychiatric Conditions or Current Significant Stressors: Children whose primary diagnosis is something other than ADHD will be excluded from participation (e.g., oppositional defiant disorder, anxiety). Further, events that have occurred over the past 6 months that could affect sleep (such as active grieving) will also be excluded from participation.
- Developmental Disabilities: Functioning below grade level for age; or as a result of scores on the IQ screening, additional assessments, or the judgment of the study clinicians, patients will be excluded if they are deemed to be significantly developmentally delayed. This includes clinically significant delays in cognitive function or the presence of other Pervasive Developmental Disorders (PDD).
- Organic Brain Injury: Children must not have a history of head trauma (requiring hospitalization), neurological disorder (such as Tourette syndrome, or restless leg movements), or any other organic disorder that could possibly affect brain function.
- Strong evidence of sleep apnea: As determined by cutoff scores on the sleep habits questionnaire. Raw scores of or greater than 6 on relevant items from the CHSQ are often used to indicate sleep apnea.
- Caffeine consumption: is greater than 3 cans per day
Show all 9Show fewer
- Stimulant or psychotropic medications: Children must be on a stable dose one week prior to the initiation of the study interventions and not require changes or addition of new medication during the intervention time.
- ADHD Medications:Children must be on a stable dose one week prior to the initiation of the study interventions and not require changes or addition of new medication during the intervention time.
- Child-bearing potential: Female subjects who are randomized to the treatment group and who are potentially able to become pregnant, must be willing to take adequate precautions to prevent pregnancy, as determined by the investigator.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
Official title: A Pilot Study Designed To Improve Sleep and Subsequent Daytime Functioning in Children Diagnosed With ADHD
This study will test the efficacy of a systematic, multi-modal intervention protocol designed to improve sleep functioning and subsequent alleviation of daytime cognitive and behavioral difficulties among children diagnosed with ADHD. It is hypothesized that children receiving behavioral and (if necessary) pharmacologic interventions targeting sleep will display improvement on objective and subjective sleep measures, neuropsychological tests, and teacher-, and parent-ratings of ADHD behaviors.
Read the detailed description
Parents, researchers, and clinicians have long suspected that inadequate sleep in many children diagnosed with Attention Deficit Hyperactivity Disorder (ADHD) can exacerbate symptoms of hyperactivity and inattentiveness, leading to further cognitive and behavioral disruptions. Extant sleep studies report that upwards of 50% of children diagnosed with ADHD display behaviors associated with chronic sleep disruption (in comparison to non-diagnosed youth). Although studies have attempted to alleviate sleep difficulties, most intervention studies have used only one treatment modality. This study will incorporate a systematic, multi-method treatment intervention protocol that will combine behavioral and pharmacologic strategies aimed to improve sleep functioning among children with ADHD.
The specific aims of this study are to (a) examine the effects of a structured sleep behavioral/pharmacologic intervention protocol on improved sleep onset and efficiency, and (b) examine how such improvements may alleviate daytime neuropsychological (i.e., response time) and behavioral deficits associated with ADHD. The study will take place at the ADHD Clinic. Twelve children (ages 6-12), following confirmed diagnosis of ADHD and who meet all criteria for evaluation, and who have signed parent/child consent/assent, will be randomly assigned to an immediate treatment or delayed treatment group (6 in each group). Children in the immediate treatment group will receive the sleep intervention protocol, while those in the delayed treatment group will initially only receive all of the sleep, activity, and daytime assessments on the same schedule as the treatment group without any of the treatment methods. They will be offered the same treatment methods as the immediate treatment group at week 5.
The study will occur in separate phases. Phase one will consist of an intake session at the ADHD Clinic to determine eligibility for the study. Phase two will immediately follow (for eligible participants) and will consist of a one-week baseline to gather sleep, neuropsychological functioning and daytime behavior data. Sleep functioning will be measured using both subjective (i.e., parent sleep logs) and objective measures (i.e., actigraphy), while response time will be assessed using a device that measures continuous reaction-time performance. Attention and other ADHD-related behaviors will be collected using parent- and teacher rating scales during baseline. Phase three, which will last 4 weeks, consists of parents of each child in the treatment group coming to the Clinic to learn a specific sequence of interventions, first beginning with behavioral methods, followed by melatonin (if necessary) to improve sleep functioning (80% above baseline). Parents of children in the delayed treatment phase will not come to the Clinic during phase three, but will be contacted for a brief phone interview once per week. They will be asked questions pertaining to any changes in sleep and daytime behaviors. Finally, Phase 4 consists of having all parents return to the ADHD Clinic, where measures administered at the end of Baseline will be repeated. At that time, those in the delayed treatment group may enter the treatment phase. A repeated measure ANOVA using group status (no treatment vs. treatment) across two time points (baseline, post-sleep intervention) will assess changes in sleep and daytime functioning over time. Although a group-by-time interaction will indicate treatment efficacy, this is a small pilot study; the small number of participants in each group likely precludes the power to determine this statistically. Instead, effect sizes and subjective measures will be used to describe and justify, if appropriate, an expansion of this study for a subsequent grant application.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- Sleep Intervention, Melatonin
- Keywords
- Attention Deficit Hyperactivity Disorder (ADHD)
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep InterventionBehavioural
A structured sleep protocol is taught to parents, use of a white noise generator
MelatoninDrug
Body Weight <40mg will be given 3mg at bedtime for two weeks Body Weight >40mg will be given 6 mg at bedtime for two weeks
| Study group | Role | What they receive |
|---|---|---|
| Immediate Treatment | Experimental | Children will receive behavioral sleep interventions and, if needed, melatonin, to improve sleep functions. Receives: Behavioral: Sleep Intervention; Drug: Melatonin |
| Delayed Treatment | Experimental | Children will only receive sleep behavior interventions for the first four weeks of the trial. Treatment with study drug will be delayed to the 5th week. Receives: Behavioral: Sleep Intervention; Drug: Melatonin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep Duration
Data was gathered via actigraphy. Data was gathered on a nightly basis for one week at baseline and at week five. Data presented is the mean nightly value (in minutes) for that week.
Measured: Baseline; Week 5
Sleep Activity (i.e., Average Amount of Time That the Participant Moved During Sleep)
Data was gathered via actigraphy. Data was gathered on a nightly basis for one week at baseline and at week five. Data presented is the mean nightly value (in minutes) of movement during sleep, for that respective week.
Measured: Baseline; Week 5
Length of Awake Time
Data was gathered via actigraphy. Data was gathered on a nightly basis for one week at baseline and at week five. Data presented is the mean nightly value (in minutes) for that respective week.
Measured: Baseline; Week 5
Percent Total Sleep
Data was gathered via actigraphy. Data on percentage of time individual was immobile during sleep was gathered on a nightly basis for one week at baseline and at week five. Data presented is the mean nightly percentage of immobility for that respective week.
Measured: Baseline, Week 5
Vanderbilt ADHD Rating Scales - Teacher (VADTRS): Inattention
35-item measure to assess behaviors consistent with ADHD. Nine items reflected the Inattention scale. Range of scores for the Attention Problems domain was 0-27. Higher scores are indicative of higher levels of inattention.
Measured: Baseline, Week 5
Vanderbilt ADHD Rating Scales - Parent (VADPRS): Inattention
35-item measure to assess behaviors consistent with ADHD. Nine items reflected the Inattention scale. Range of scores for the Attention Problems domain was 0-27. Higher scores are indicative of higher levels of inattention.
Measured: Baseline, Week 5
Vanderbilt ADHD Rating Scales - Teacher (VADTRS): Hyperactivity/Impulsivity
35-item measure to assess behaviors consistent with ADHD. Nine items reflected the Inattention scale. Range of scores for the Hyperactivity/Impulsivity domain was 0-27. Higher scores are indicative of higher levels of hyperactive/impulsive behaviors.
Measured: Baseline, Week 5
Vanderbilt ADHD Rating Scales - Parent (VADPRS): Hyperactivity/Impulsivity
35-item measure to assess behaviors consistent with ADHD. Nine items reflected the Inattention scale. Range of scores for the Hyperactivity/Impulsivity domain was 0-27. Higher scores are indicative of higher levels of hyperactive/impulsive behaviors.
Measured: Baseline, Week 35
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2009 (estimated)
- Study startJan 2010
- Primary completionJun 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Attention Deficit Hyperactivity DisorderStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard Gilman, Ph.D., Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00867451
- Sponsor's protocol ID
- CCHMC IRB# 2008-1287
- Status last verified
- Mar 2012
- First submitted
- 20 Mar 2009
- Last updated
- 16 Mar 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Designed To Improve Sleep and Subsequent Daytime Functioning in Children Diagnosed With ADHD
- ClinicalTrials.gov ID
- NCT00867451
- Acronym / sponsor ID
- CCHMC IRB# 2008-1287
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- Attention Deficit Hyperactivity Disorder (ADHD)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 23 Mar 2009 (estimated)
- Results
- Posted 16 Mar 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will test the efficacy of a systematic, multi-modal intervention protocol designed to improve sleep functioning and subsequent alleviation of daytime cognitive and behavioral difficulties among children diagnosed with ADHD. It is hypothesized that children receiving behavioral and (if necessary) pharmacologic interventions targeting sleep will display improvement on objective and subjective sleep measures, neuropsychological tests, and teacher-, and parent-ratings of ADHD behaviors.
Detailed description
Parents, researchers, and clinicians have long suspected that inadequate sleep in many children diagnosed with Attention Deficit Hyperactivity Disorder (ADHD) can exacerbate symptoms of hyperactivity and inattentiveness, leading to further cognitive and behavioral disruptions. Extant sleep studies report that upwards of 50% of children diagnosed with ADHD display behaviors associated with chronic sleep disruption (in comparison to non-diagnosed youth). Although studies have attempted to alleviate sleep difficulties, most intervention studies have used only one treatment modality. This study will incorporate a systematic, multi-method treatment intervention protocol that will combine behavioral and pharmacologic strategies aimed to improve sleep functioning among children with ADHD.
The specific aims of this study are to (a) examine the effects of a structured sleep behavioral/pharmacologic intervention protocol on improved sleep onset and efficiency, and (b) examine how such improvements may alleviate daytime neuropsychological (i.e., response time) and behavioral deficits associated with ADHD. The study will take place at the ADHD Clinic. Twelve children (ages 6-12), following confirmed diagnosis of ADHD and who meet all criteria for evaluation, and who have signed parent/child consent/assent, will be randomly assigned to an immediate treatment or delayed treatment group (6 in each group). Children in the immediate treatment group will receive the sleep intervention protocol, while those in the delayed treatment group will initially only receive all of the sleep, activity, and daytime assessments on the same schedule as the treatment group without any of the treatment methods. They will be offered the same treatment methods as the immediate treatment group at week 5.
The study will occur in separate phases. Phase one will consist of an intake session at the ADHD Clinic to determine eligibility for the study. Phase two will immediately follow (for eligible participants) and will consist of a one-week baseline to gather sleep, neuropsychological functioning and daytime behavior data. Sleep functioning will be measured using both subjective (i.e., parent sleep logs) and objective measures (i.e., actigraphy), while response time will be assessed using a device that measures continuous reaction-time performance. Attention and other ADHD-related behaviors will be collected using parent- and teacher rating scales during baseline. Phase three, which will last 4 weeks, consists of parents of each child in the treatment group coming to the Clinic to learn a specific sequence of interventions, first beginning with behavioral methods, followed by melatonin (if necessary) to improve sleep functioning (80% above baseline). Parents of children in the delayed treatment phase will not come to the Clinic during phase three, but will be contacted for a brief phone interview once per week. They will be asked questions pertaining to any changes in sleep and daytime behaviors. Finally, Phase 4 consists of having all parents return to the ADHD Clinic, where measures administered at the end of Baseline will be repeated. At that time, those in the delayed treatment group may enter the treatment phase. A repeated measure ANOVA using group status (no treatment vs. treatment) across two time points (baseline, post-sleep intervention) will assess changes in sleep and daytime functioning over time. Although a group-by-time interaction will indicate treatment efficacy, this is a small pilot study; the small number of participants in each group likely precludes the power to determine this statistically. Instead, effect sizes and subjective measures will be used to describe and justify, if appropriate, an expansion of this study for a subsequent grant application.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate Treatment | Experimental | Behavioral: Sleep Intervention, Drug: MelatoninChildren will receive behavioral sleep interventions and, if needed, melatonin, to improve sleep functions. |
| Delayed Treatment | Experimental | Behavioral: Sleep Intervention, Drug: MelatoninChildren will only receive sleep behavior interventions for the first four weeks of the trial. Treatment with study drug will be delayed to the 5th week. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Consent: The family must provide signature of informed consent by parents or legal guardians
- Assent: Children must provide assent to participate in the study (via signature on assent form)
- Age at time of Screening: 6 years to 12 years, inclusive
- Gender: includes male and female children.
- ADHD Diagnostic Status: The primary criterion is that patients must meet DSM-IV criteria for ADHD.
Key exclusion criteria (9 listed)
- Understanding Level: The parent is not fluent in the language of the wording used in the consent form.
- Exclusionary Psychiatric Conditions or Current Significant Stressors: Children whose primary diagnosis is something other than ADHD will be excluded from participation (e.g., oppositional defiant disorder, anxiety). Further, events that have occurred over the past 6 months that could affect sleep (such as active grieving) will also be excluded from participation.
- Developmental Disabilities: Functioning below grade level for age; or as a result of scores on the IQ screening, additional assessments, or the judgment of the study clinicians, patients will be excluded if they are deemed to be significantly developmentally delayed. This includes clinically significant delays in cognitive function or the presence of other Pervasive Developmental Disorders (PDD).
- Organic Brain Injury: Children must not have a history of head trauma (requiring hospitalization), neurological disorder (such as Tourette syndrome, or restless leg movements), or any other organic disorder that could possibly affect brain function.
- Strong evidence of sleep apnea: As determined by cutoff scores on the sleep habits questionnaire. Raw scores of or greater than 6 on relevant items from the CHSQ are often used to indicate sleep apnea.
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 |
|---|---|---|
| Sleep InterventionA structured sleep protocol is taught to parents, use of a white noise generator | Behavioural | Delayed Treatment, Immediate Treatment |
| MelatoninBody Weight <40mg will be given 3mg at bedtime for two weeks Body Weight >40mg will be given 6 mg at bedtime for two weeks | Drug | Delayed Treatment, Immediate Treatment |
Primary outcome
Sleep Duration
Time frame: Baseline; Week 5
Data was gathered via actigraphy. Data was gathered on a nightly basis for one week at baseline and at week five. Data presented is the mean nightly value (in minutes) for that week.
Sleep Activity (i.e., Average Amount of Time That the Participant Moved During Sleep)
Time frame: Baseline; Week 5
Data was gathered via actigraphy. Data was gathered on a nightly basis for one week at baseline and at week five. Data presented is the mean nightly value (in minutes) of movement during sleep, for that respective week.
Length of Awake Time
Time frame: Baseline; Week 5
Data was gathered via actigraphy. Data was gathered on a nightly basis for one week at baseline and at week five. Data presented is the mean nightly value (in minutes) for that respective week.
Percent Total Sleep
Time frame: Baseline, Week 5
Data was gathered via actigraphy. Data on percentage of time individual was immobile during sleep was gathered on a nightly basis for one week at baseline and at week five. Data presented is the mean nightly percentage of immobility for that respective week.
Vanderbilt ADHD Rating Scales - Teacher (VADTRS): Inattention
Time frame: Baseline, Week 5
35-item measure to assess behaviors consistent with ADHD. Nine items reflected the Inattention scale. Range of scores for the Attention Problems domain was 0-27. Higher scores are indicative of higher levels of inattention.
Vanderbilt ADHD Rating Scales - Parent (VADPRS): Inattention
Time frame: Baseline, Week 5
35-item measure to assess behaviors consistent with ADHD. Nine items reflected the Inattention scale. Range of scores for the Attention Problems domain was 0-27. Higher scores are indicative of higher levels of inattention.
Vanderbilt ADHD Rating Scales - Teacher (VADTRS): Hyperactivity/Impulsivity
Time frame: Baseline, Week 5
35-item measure to assess behaviors consistent with ADHD. Nine items reflected the Inattention scale. Range of scores for the Hyperactivity/Impulsivity domain was 0-27. Higher scores are indicative of higher levels of hyperactive/impulsive behaviors.
Vanderbilt ADHD Rating Scales - Parent (VADPRS): Hyperactivity/Impulsivity
Time frame: Baseline, Week 35
35-item measure to assess behaviors consistent with ADHD. Nine items reflected the Inattention scale. Range of scores for the Hyperactivity/Impulsivity domain was 0-27. Higher scores are indicative of higher levels of hyperactive/impulsive behaviors.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Richard Gilman, Ph.D. principal investigator
Children's Hospital Medical Center, Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Sleep Intervention and Melatonin in people with Attention Deficit Hyperactivity Disorder, 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 7 inclusion and 9 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 Mar 2012. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Mar 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Sleep Duration (time frame: Baseline; Week 5). 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 16 Mar 2012.