Improving Sleep and Daytime Functioning Among Children Diagnosed With Attention Deficit Hyperactivity Disorder (ADHD)

• Status: Completed
• Trial end date: 2011-07-01
• Target enrollment: 0
• Participant gender: All

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. 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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Hospital Medical Center, Cincinnati
• Treatments: Melatonin

Criteria

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.

• Functioning at appropriate grade level for age.

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: 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

• 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.