Phase 4
N=27
Does Pharmacological Treatment of Attention Deficit Hyperactivity Disorder (ADHD) in Adults Enhance Parenting Performance?
ADHD
Bottom Line
View on ClinicalTrials.gov: NCT01127607 ↗Enrolled (actual)
27
Serious AEs
0.0%
Results posted
Jun 2014
Primary outcome: Primary: Dyadic Parent-Child Interaction Coding System (DPICS) - Behavior Counts — 67.2; 42.1; 53.8; 40.1 behaviors
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- lisdexamfetamine (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Florida International University
- Primary completion
- Jul 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Dyadic Parent-Child Interaction Coding System (DPICS) - Behavior Counts |
67.2; 42.1; 53.8; 40.1; 14.5; 9.0 | — |
| PRIMARY Dyadic Parent-Child Interaction Coding System (DPICS) - Behavior Percentages |
1.2; 6.0; 2.8; 5.7; 5.3; 5.9 | — |
| SECONDARY Alabama Parenting Questionnaire (APQ) |
24.85; 24.33; 39.38; 37.78; 12.23; 12.33 | — |
| SECONDARY Disruptive Behavior Disorders Rating Scale (DBD) |
1.55; 1.34; 2.11; 1.85; 1.17; 1.12 | — |
| SECONDARY Impairment Rating Scale (IRS) |
2.38; 1.91; 2.46; 1.30; 2.77; 2.27 | — |
| SECONDARY Sheehan Disability Scale (SDS) |
4.36; 2.26 | — |
| SECONDARY Dyadic Parent-Child Interaction Coding System (DPICS) |
61.7; 58.2; 45.2; 48.6; 15.4; 14.8 | — |
| SECONDARY Dyadic Parent-Child Interaction Coding System (DPICS) - Behavior Percentages |
1.2; 6.0; 2.8; 5.7; 5.3; 5.9 | — |
| SECONDARY Pittsburgh Side Effect Rating Scale |
0.04; 0.26 | — |
| SECONDARY Adult ADHD Rating Scale (ADHD RS) |
17.85; 8.82; 14.77; 5.64; 32.62; 14.46 | — |
| SECONDARY Parenting Stress Index (PSI)--Total Stress |
241.54; 262.67 | — |
| SECONDARY Parenting Locus of Control (PLC) |
79.00; 80.00 | — |
| SECONDARY Brown Attention Deficit Scale (BAADS) |
73.38; 66.4; 75.54; 65.10; 72.46; 61.20 | — |
| SECONDARY Social Skills Rating System (SSRS) |
86.64; 89.90; 113.81; 111.80 | — |
| SECONDARY Disruptive Behavior Disorder Rating Scale (DBD) |
1.64; 1.60; 1.25; 1.09; 1.04; 0.76 | — |
| SECONDARY Impairment Rating Scale (IRS) |
2.38; 1.91; 2.46; 1.30; 2.77; 2.27 | — |
| SECONDARY Sheehan Disability Scale (SDS) |
4.36; 2.26 | — |
| SECONDARY ADHD Severity Clinical Global Impressions Severity Subscale |
3.78; 2.36 | — |
| SECONDARY Barkley Home Situations Questionnaire (HSQ) |
9.30; 8.67 | — |
| SECONDARY Pittsburgh Side Effect Rating Scale Mean Severity Rating. |
0.28; 0.26 | — |
| SECONDARY Resting Blood Pressure |
123.40; 122.33; 76.10; 75.11 | — |
| SECONDARY Alabama Parenting Questionnaire (APQ) |
24.85; 24.33; 39.38; 37.78; 12.23; 12.33 | — |
| SECONDARY Impairment Rating Scale (IRS) |
2.38; 1.91; 2.46; 1.30; 2.77; 2.27 | — |
| SECONDARY Weight |
76.0; 69.62 | — |
| SECONDARY Resting Pulse |
74.44; 77.13 | — |
| SECONDARY Pittsburgh Side Effects Rating Scale - Percent Present for All Reported Adverse Events Occurring at a Rate of 5% or More |
0; 0; 0; 11.8; 2.6; 19.4 | — |
| SECONDARY Adult ADHD Rating Scale Completed at the End of the Med Optimization Phase |
23.12; 9.77; 17.81; 8.00; 40.85; 17.77 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT01127607). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.