Does Pharmacological Treatment of Attention Deficit Hyperactivity Disorder (ADHD) in Adults Enhance Parenting Performance?

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Florida International University.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Florida International University
ClinicalTrials.gov Identifier:
NCT01127607
First received: May 19, 2010
Last updated: April 9, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention Phase
ADHD
Drug: lisdexamfetamine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Does Pharmacological Treatment of Attention Deficit Hyperactivity Disorder (ADHD) in Adults Enhance Parenting Performance?

Resource links provided by NLM:


Further study details as provided by Florida International University:

Primary Outcome Measures:
  • Dyadic Parent-Child Interaction Coding System (DPICS) [ Time Frame: week 8 ] [ Designated as safety issue: No ]
    collected at end of 4 week double-blind, between-group randomized trial of optimally dosed lisdexamfetamine vs. placebo


Secondary Outcome Measures:
  • Adult ADHD Rating Scale (ADHD RS) [ Time Frame: week 4 ] [ Designated as safety issue: No ]
    measures change in ADHD symptoms

  • Alabama Parenting Questionnaire (APQ) [ Time Frame: week 4 ] [ Designated as safety issue: No ]
    measures change in parenting practices

  • Parenting Stress Inventory (PSI) [ Time Frame: week 4 ] [ Designated as safety issue: No ]
    measures change in stress of parent child interactions

  • Parenting Locus of Control (PLC) [ Time Frame: week 4 ] [ Designated as safety issue: No ]
    self completed parenting measure

  • The Brown Attention-Deficit Disorder Scales (BAADS) [ Time Frame: week 4 ] [ Designated as safety issue: No ]
    measures executive functioning

  • Social Skills Rating Scale (SSRS) [ Time Frame: week 4 ] [ Designated as safety issue: No ]
    measures child's interactions with peers and adults

  • Disruptive Behavior Disorders Rating Scale (DBD) [ Time Frame: week 4 ] [ Designated as safety issue: No ]
    measures externalizing symptoms in children

  • Impairment Rating Scale (IRS) [ Time Frame: week 4 ] [ Designated as safety issue: No ]
    measures global functioning of child

  • Sheehan Disability Scale (SDS) [ Time Frame: week 4 ] [ Designated as safety issue: No ]
    measures global functioning of adults

  • ADHD Severity Clinical Global Impressions (CGI) [ Time Frame: week 4 ] [ Designated as safety issue: No ]
    measures level of ADHD symptoms

  • Barkley's Home Situations Questionnaire (HSQ) [ Time Frame: week 4 ] [ Designated as safety issue: No ]
    measures child functioning in the evening

  • Dyadic Parent-Child Interaction Coding System (DPICS) [ Time Frame: week 4 ] [ Designated as safety issue: No ]
    acute effects of lisdexamfetamine vs. placebo

  • Adverse Events [ Time Frame: week 1 ] [ Designated as safety issue: Yes ]
    Will be measured using subject report on the Pittsburgh Side Effects Rating Scales as well as spontaneous report of the subject

  • Vital Signs [ Time Frame: week 1 ] [ Designated as safety issue: Yes ]
    resting blood pressure, pulse and weight

  • Abbreviated Alabama Parenting Questionnaire (brief-APQ) [ Time Frame: week 5 ] [ Designated as safety issue: No ]
    brief form of the APQ

  • ADHD Rating Scale (ADHD RS) [ Time Frame: week 8 ] [ Designated as safety issue: No ]
    measures change in ADHD symptoms

  • Alabama Parenting Questionnaire (APQ) [ Time Frame: week 8 ] [ Designated as safety issue: No ]
    measures change in parenting practices

  • Parenting Stress Index (PSI) [ Time Frame: week 8 ] [ Designated as safety issue: No ]
    measures change in stress of parent child interactions

  • Parenting Locus of Control (PLC) [ Time Frame: week 8 ] [ Designated as safety issue: No ]
    self completed parenting measure

  • Brown Attention Deficit Scale (BAADS) [ Time Frame: week 8 ] [ Designated as safety issue: No ]
    measures executive functioning

  • Social Skills Rating Scale (SSRS) [ Time Frame: week 8 ] [ Designated as safety issue: No ]
    measures child's interactions with peers and adults

  • Disruptive Behavior Disorder Rating Scale (DBD) [ Time Frame: week 8 ] [ Designated as safety issue: No ]
    measures externalizing symptoms in children

  • Impairment Rating Scale (IRS) [ Time Frame: week 8 ] [ Designated as safety issue: No ]
    measures global functioning of child

  • Sheehan Disability Scale (SDS) [ Time Frame: week 8 ] [ Designated as safety issue: No ]
    measures global functioning of adults

  • ADHD Severity CGI [ Time Frame: week 8 ] [ Designated as safety issue: No ]
    measures level of ADHD symptoms in children and adults

  • Barkley Home Situations Questionnaire (HSQ) [ Time Frame: week 5 ] [ Designated as safety issue: No ]
    Measures child's functioning in the evening

  • Barkley HSQ [ Time Frame: week 6 ] [ Designated as safety issue: No ]
    Measures child's functioning in the evening

  • Barkley HSQ [ Time Frame: week 7 ] [ Designated as safety issue: No ]
    Measures child's functioning in the evening

  • Barkley HSQ [ Time Frame: week 8 ] [ Designated as safety issue: No ]
    Measures child's functioning in the evening

  • adverse events [ Time Frame: week 2 ] [ Designated as safety issue: Yes ]
    Will be measured using subject report on the Pittsburgh Side Effects Rating Scales as well as spontaneous report of the subject

  • adverse events [ Time Frame: week 3 ] [ Designated as safety issue: Yes ]
    Will be measured using subject report on the Pittsburgh Side Effects Rating Scales as well as spontaneous report of the subject

  • adverse events [ Time Frame: week 4 ] [ Designated as safety issue: Yes ]
    Will be measured using subject report on the Pittsburgh Side Effects Rating Scales as well as spontaneous report of the subject

  • adverse events [ Time Frame: week 5 ] [ Designated as safety issue: Yes ]
    Will be measured using subject report on the Pittsburgh Side Effects Rating Scales as well as spontaneous report of the subject

  • adverse events [ Time Frame: week 6 ] [ Designated as safety issue: Yes ]
    Will be measured using subject report on the Pittsburgh Side Effects Rating Scales as well as spontaneous report of the subject

  • adverse events [ Time Frame: week 7 ] [ Designated as safety issue: Yes ]
    Will be measured using subject report on the Pittsburgh Side Effects Rating Scales as well as spontaneous report of the subject

  • adverse events [ Time Frame: week 8 ] [ Designated as safety issue: Yes ]
    Will be measured using subject report on the Pittsburgh Side Effects Rating Scales as well as spontaneous report of the subject

  • vital signs [ Time Frame: week 2 ] [ Designated as safety issue: Yes ]
    resting blood pressure, pulse and weight

  • vital signs [ Time Frame: week 3 ] [ Designated as safety issue: Yes ]
    resting blood pressure, pulse and weight

  • vital signs [ Time Frame: week 4 ] [ Designated as safety issue: Yes ]
    resting blood pressure, pulse and weight

  • vital signs [ Time Frame: week 8 ] [ Designated as safety issue: Yes ]
    resting blood pressure, pulse and weight

  • Brief Alabama Parenting Questionnaire APQ [ Time Frame: week 6 ] [ Designated as safety issue: No ]
    brief form of the APQ

  • Brief APQ [ Time Frame: week 7 ] [ Designated as safety issue: Yes ]
    brief form of the APQ


Estimated Enrollment: 70
Study Start Date: November 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: stimulant medication Drug: lisdexamfetamine
will do 3 week with-in subject lead in phase to find optimal dose ranging from 30 mg to 70mg
Other Name: vyvanse
Placebo Comparator: placebo pill Drug: lisdexamfetamine
will do 3 week with-in subject lead in phase to find optimal dose ranging from 30 mg to 70mg
Other Name: vyvanse

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 (phase 1). 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). 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

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01127607

Contacts
Contact: James G Waxmonsky, M.D. 716 829 2244 ext 142 jgw@buffalo.edu

Locations
United States, Florida
Florida International University Recruiting
Miami, Florida, United States, 33199
Contact: Daniel Bolea    305-348-0477      
Principal Investigator: James G Waxmonsky, M.D.         
Sub-Investigator: Daniel A Waschbusch, Ph.D.         
Sub-Investigator: William E Pelham, Ph.D.         
Florida International University Not yet recruiting
Miami, Florida, United States, 33199
Contact: Waxmonsky       jwaxmons@fiu.edu   
Sponsors and Collaborators
Florida International University
Investigators
Principal Investigator: James G Waxmonsky, M.D. Florida International University
  More Information

No publications provided

Responsible Party: Florida International University
ClinicalTrials.gov Identifier: NCT01127607     History of Changes
Other Study ID Numbers: IITWW#2
Study First Received: May 19, 2010
Last Updated: April 9, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Florida International University:
parenting

Additional relevant MeSH terms:
Hyperkinesis
Attention Deficit Disorder with Hyperactivity
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders

ClinicalTrials.gov processed this record on April 16, 2014