Clinical trial NCT01127607: Does Pharmacological Treatment of Attention Deficit Hyperactivity Disorder (ADHD) in Adults Enhance Parenting Performance?
Official title: Does Pharmacological Treatment of Attention Deficit Hyperactivity Disorder (ADHD) in Adults Enhance Parenting Performance?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: ADHD
Keywords: parenting
Lead sponsor: Florida International University
Sponsor class: OTHER
First posted: 2010-05-21
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Parents with a diagnosis of ADHD, who also have a child with an ADHD between the ages of 5-16

Exclusion Criteria:

* Parents with any of the following: any identified structural heart abnormality or other health condition that significantly affects heart performance (e.g., hypertension), a resting systolic blood pressure ≥140 and diastolic blood pressure ≥90, pregnant or breast feeding, significant psychiatric problems other than ADHD that currently require medication or any emergent psychiatric treatment, medical/psychiatric illness that could be worsened by stimulants (such as a seizure disorder, Tourette's Disorder or hyperthyroidism), or alcohol or substance abuse problems in the past 6 months.
* Children with any of the following: any psychiatric problem other than ADHD, Oppositional Defiant Disorder (ODD), or Conduct Disorder (CD) that requires medication or any emergent psychiatric treatment, either parent or child has participated in the same parent-child interaction task used in this study in the last 6 months, either as part of a study or a clinical treatment.

Primary outcomes:
measure: Dyadic Parent-Child Interaction Coding System (DPICS) - Behavior Counts
timeFrame: study endpoint- end of period II (between subjects trial)
measure: Dyadic Parent-Child Interaction Coding System (DPICS) - Behavior Percentages
timeFrame: study endpoint- end of period II (between subjects trial)
Secondary outcomes:
measure: Alabama Parenting Questionnaire (APQ)
timeFrame: baseline and week 4
measure: Disruptive Behavior Disorders Rating Scale (DBD)
timeFrame: baseline and week 4
measure: Impairment Rating Scale (IRS)
timeFrame: baseline and week 4
measure: Sheehan Disability Scale (SDS)
timeFrame: baseline and week 4
measure: Dyadic Parent-Child Interaction Coding System (DPICS)
timeFrame: weeks 4 and weeks 5 (period I within subjects trial)
measure: Dyadic Parent-Child Interaction Coding System (DPICS) - Behavior Percentages
timeFrame: weeks 4 and weeks 5 (period I within subjects trial)
measure: Pittsburgh Side Effect Rating Scale
timeFrame: baseline and end of dose optimization phase/week 4
measure: Adult ADHD Rating Scale (ADHD RS)
timeFrame: study endpoint- end of period II (between subjects trial)
measure: Parenting Stress Index (PSI)--Total Stress
timeFrame: study endpoint- end of period II (between subjects trial)
measure: Parenting Locus of Control (PLC)
timeFrame: study endpoint- end of period II (between subjects trial)
measure: Brown Attention Deficit Scale (BAADS)
timeFrame: study endpoint- end of period II (between subjects trial)
measure: Social Skills Rating System (SSRS)
timeFrame: study endpoint- end of period II (between subjects trial)
measure: Disruptive Behavior Disorder Rating Scale (DBD)
timeFrame: study endpoint- end of period II (between subjects trial)
measure: Impairment Rating Scale (IRS)
timeFrame: study endpoint- end of period II (between subjects trial)
measure: Sheehan Disability Scale (SDS)
timeFrame: study endpoint- end of period II (between subjects trial)
measure: ADHD Severity Clinical Global Impressions Severity Subscale
timeFrame: study endpoint- end of period II (between subjects trial)
measure: Barkley Home Situations Questionnaire (HSQ)
timeFrame: study endpoint- end of period II (between subjects trial)
measure: Pittsburgh Side Effect Rating Scale Mean Severity Rating.
timeFrame: study endpoint- end of period II (between subjects trial)
measure: Resting Blood Pressure
timeFrame: study endpoint- end of period II (between subjects trial)
measure: Alabama Parenting Questionnaire (APQ)
timeFrame: study endpoint- end of period II (between subjects trial)
measure: Impairment Rating Scale (IRS)
timeFrame: study endpoint- end of period II (between subjects trial)
measure: Weight
timeFrame: study endpoint- end of period II (between subjects trial)
measure: Resting Pulse
timeFrame: study endpoint- end of period II (between subjects trial)
measure: Pittsburgh Side Effects Rating Scale - Percent Present for All Reported Adverse Events Occurring at a Rate of 5% or More
timeFrame: end of medication optimization phase/week 4
measure: Adult ADHD Rating Scale Completed at the End of the Med Optimization Phase
timeFrame: baseline and end of med optimization phase/week 4
Other outcomes:
Locations:
city: Miami
country: United States
facility: Florida International University
state: Florida
Study officials:
affiliation: Florida International University
name: James G Waxmonsky, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Babinski DE, Waxmonsky JG, Waschbusch DA, Humphery H, Pelham WE Jr. Parent-Reported Improvements in Family Functioning in a Randomized Controlled Trial of Lisdexamfetamine for Treatment of Parental Attention-Deficit/Hyperactivity Disorder. J Child Adolesc Psychopharmacol. 2017 Apr;27(3):250-257. doi: 10.1089/cap.2016.0129. Epub 2016 Dec 19.
citation: Waxmonsky JG, Waschbusch DA, Babinski DE, Humphrey HH, Alfonso A, Crum KI, Bernstein M, Slavec J, Augustus JN, Pelham WE. Does pharmacological treatment of ADHD in adults enhance parenting performance? Results of a double-blind randomized trial. CNS Drugs. 2014 Jul;28(7):665-77. doi: 10.1007/s40263-014-0165-3.