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View Clinical Trial (Medical Research Study)
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Improving Sleep and Daytime Functioning Among Children Diagnosed With Attention Deficit Hyperactivity Disorder (ADHD) - NCT00867451-45229 (Clinical Trial 364514)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy364514.aspx
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| City: |
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Cincinnati |
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State:
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OH |
| Zip Code: |
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45229 |
| Conditions: |
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Attention Deficit Hyperactivity Disorder |
| Purpose: |
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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 a greater improvement on objective and subjective sleep measures,
neuropsychological tests, and teacher-, and parent-ratings of ADHD behaviors than a
no-treatment control group over the course of the study.
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| Study summary: |
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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 and will consist of parents on the wait list. 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 a treatment or intervention group
(6 in each group, with participants matched on age). Children in the treatment group will
receive the sleep intervention protocol, while those in the control group will receive all
of the sleep, activity, and daytime assessments on the same schedule as the treatment group,
but they will not receive any of the treatment methods.
The study will occur in four 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 control group 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. A repeated measure ANOVA using group status (control 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. |
| Criteria: |
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Inclusion Criteria:
- 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.
- Cognitive Functioning: IQ of greater than 80 as estimate by Vocabulary and Block
Design subtests of the Wechsler Abbreviated Scale of Intelligence (WASI)(to be used
if IQ has not been assessed previously within the past 3 years).
Exclusion Criteria:
- 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: 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
- Stimulant or psychotropic medications: Children must not have been taking within the
past 4 weeks
- ADHD Medications: Children must not be taking medication prescribed clinically for
symptoms of ADHD for one week prior to initiation of study interventions.
- 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. |
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| Study is available at: |
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Cincinnati Children's Hospital Medical Center
Cincinnati, OH 45229
United States
Primary Contact:
Richard Gilman, Ph.D.
Email: richard.gilman@ccchme.org
Phone: 513-636-8172
Secondary Contact:
Richard Gilman, Ph.D.
Email: richard.gilman@cchmc.org
Phone: 513-636-8172 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 16, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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