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

NCT00867451 | Completed Phase 1 Results

• 1 other identifier: CCHMC IRB# 2008-1287
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

Attention Deficit Hyperactivity Disorder (ADHD)

Outcome Measures

Primary Outcomes (8)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  Baseline, Week 35

Study Arms (2)

Immediate Treatment

EXPERIMENTAL

Children will receive behavioral sleep interventions and, if needed, melatonin, to improve sleep functions.

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.

Behavioral: Sleep Intervention; Drug: Melatonin

Interventions

Sleep Intervention BEHAVIORAL

A structured sleep protocol is taught to parents, use of a white noise generator

Delayed Treatment; Immediate Treatment

Melatonin DRUG

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

Delayed Treatment; Immediate Treatment

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Understanding Level: The parent is not fluent in the language of the wording used in the consent form.
• 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.

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

• Title: Richard Gilman, Ph.D.
• Organization: Cincinnati Children's Hospital Medical Center

richard.gilman@cchmc.org

513-636-8172

Study Officials

• Richard Gilman, Ph.D.

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2009
• First Posted: March 23, 2009
• Study Start: January 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: July 1, 2011
• Last Updated: March 16, 2012
• Results First Posted: March 16, 2012

Record last verified: 2012-03

Locations

US (1)