Improving Sleep and Daytime Functioning Among Children Diagnosed With Attention Deficit Hyperactivity Disorder (ADHD)
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 1/Phase 2

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.
    

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.
    

Intervention name(s): Sleep Intervention; Melatonin
Intervention type(s): Behavioral; Drug
Intervention description(s): A structured sleep protocol is taught to parents, use of a white noise generator; 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
Intervention MeSH terms: Melatonin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Attention Deficit Hyperactivity Disorder (ADHD)