Does Pharmacological Treatment of Attention Deficit Hyperactivity Disorder (ADHD) in Adults Enhance Parenting Performance?
Condition: ADHD
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 4

Summary: 
      It is now well recognized that Attention-Deficit/Hyperactivity Disorder (ADHD) is a chronic
      disorder of childhood that extends into adulthood for many individuals. A number of
      impairments in daily life functioning have been identified in adults with ADHD, including
      marital distress, risky driving, and using less effective parenting practices (e.g., Barkley,
      2006).

      Specifically, some parents with ADHD have been found to use inconsistent discipline, less
      parental involvement, and less positive reinforcement with their children compared to parents
      without ADHD (e.g., Chen & Johnston, 2007; Chronis-Tuscano, Clarke, Rooney, Diaz, & Pian,
      2008). While there is some evidence that stimulant medication improves parental functioning
      for adults with ADHD, only one study has specifically explored the use of stimulant
      medication and parenting(Chronis-Tuscano, Seymour, Stine, Jones, Jiles, Rooney, et al.,
      2008).

      The purpose of this study is to explore whether or not the stimulant medication,
      lisdexamfetamine, improves parent functioning. Measures of parenting behavior, parental
      psychosocial functioning, and child psychosocial functioning will be collected. It is
      hypothesized that lisdexamfetamine will be associated with some improvement in these
      assessments.
    

Detailed description: 
      Seventy families with at least one parent (either mother or father who will serve as the
      identified subject) and a school-aged child (ages 5-16) with ADHD will be recruited to
      participate in a randomized, placebo-controlled trial of lisdexamfetamine to assess the acute
      and prolonged effects of medication usage on parent-child interactions. The protocol will
      employ traditional self-report measures of parental competency and functioning used in other
      studies, but will supplement them with one of the most widely used observational laboratory
      tasks.

      Families will be recruited on a rolling basis and the length of the study will be
      approximately 8 weeks. In the first three weeks of the study, parents will complete the dose
      optimization phase to find the optimal dose of lisdexamfetamine. Lisdexamfetamine will be
      initiated at a dose of 30mg and increased to 50mg for week 2 and 70mg for week 3. During week
      4, measures of the acute effects of lisdexamfetamine will be collected, and parents will
      complete the observational laboratory parent child interaction tasks two times (i.e., on
      lisdexamfetamine and on placebo- phase I). In the remaining four weeks of the study (phase 2)
      a between subjects comparison will be conducted. Half of the parents will be randomized to
      receive lisdexamfetamine and half will receive a placebo. Measures of parent functioning will
      once again be collected at the end of phase 2 and parents will complete the observational
      laboratory task, which will allow for exploration of prolonged lisdexamfetamine treatment on
      parent-child interactions.
    

Intervention name(s): lisdexamfetamine
Intervention type(s): Drug
Intervention description(s): 3 week with-in subject lead in phase to find optimal dose ranging from 30 mg to 70mg
Other intervention name(s): vyvanse
Intervention MeSH terms: Lisdexamfetamine Dimesylate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: parenting