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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Florida International University
ClinicalTrials.gov Identifier:
NCT01127607
First received: May 19, 2010
Last updated: June 10, 2014
Last verified: June 2014
  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) - Behavior Counts [ Time Frame: study endpoint- end of period II (between subjects trial) ] [ Designated as safety issue: No ]
    Observations of parents and children as they interact with each other during a five minute homework task and during a 10 minute non-academic task. Interactions were recorded and later coded by trained observers. Observers counted number of parent and child behaviors. Average number of behaviors per group were computed. Three subjects dropped prior to completing this assessment and one participant completed the other endpoint measures but not the DPICS, which is why the total N for this outcome is 23 at study endpoint. At end of period II (study endpoint), the medication group (n=10) was compared to the placebo group (N=13).

  • Dyadic Parent-Child Interaction Coding System (DPICS) - Behavior Percentages [ Time Frame: study endpoint- end of period II (between subjects trial) ] [ Designated as safety issue: No ]
    Observations of parents and children as they interact with each other during a five minute homework task and during a 10 minute non-academic task. Interactions were recorded and later coded by trained observers. Observers counted number of parent and child behaviors. Percentages of behaviors as a function of total verbalizations (for praise, negative talk, demanding) or as a function of commands and questions (for impatient and responsive) were computed.Three subjects dropped prior to completing this assessment and one participant completed the other endpoint measures but not the DPICS, which is why the total N for this outcome is 23 at study endpoint. At end of period II (study endpoint), the medication group (n=10) was compared to the placebo group (N=13).


Secondary Outcome Measures:
  • Alabama Parenting Questionnaire (APQ) [ Time Frame: baseline and week 4 ] [ Designated as safety issue: No ]

    measures change in parenting practices.The APQ is a 42-item measure (each item ranges from 1/always to 5/never) on which parents are asked to indicate the frequency with which they implement the following parenting practices: involvement (10 items range 10-50- higher scores mean more parental involvement), positive parenting (6 items with range of 6 to 30 and higher scores indicate greater use of praise), poor monitoring/supervision (10 items with range of 10 to 50 and higher scores indicate less supervision/monitoring), inconsistent discipline(6 items with range of 6 to 30 and higher scores indicate greater problems with inconsistent discipline), and corporal punishment (3 items with range of 3-15 and greater scores indicate more use of corporal punishment). Items are rated on a 5-point scale, ranging from 1 ("never") to 5 ("always"). Items summed into composite scales.

    Within subject comparison of no medication baseline vs. optimal dose medication.


  • Disruptive Behavior Disorders Rating Scale (DBD) [ Time Frame: baseline and week 4 ] [ Designated as safety issue: No ]
    Parent ratings of their child's symptoms of attention-deficit hyperactivity disorder (ADHD), oppositional defiant disorder (ODD), and conduct disorder (CD). Measure consists of 45 items each rated on a Likert scale that ranges from 0 (not at all) to 3 (very much). Items are averaged to form adhd-inattention, adhd-hyperactive/impulsive, ODD, and CD scores.Within subject comparison of no medication baseline vs. optimal dose medication. ADHD subscale consists of 20 items with range of 0 to 60. ODD subscale consists of 9 items with range of 0 to 27. CD subscale consists of 15 items with range of 0 to 45. For all subscales, higher scores indicate more severe symptoms.

  • Impairment Rating Scale (IRS) [ Time Frame: baseline and week 4 ] [ Designated as safety issue: No ]
    Parent ratings of their child's functioning and need for treatment in developmentally important domains. Ratings are completed using visual-analogue scales that are anchored at the low end by "no problems / no need for treatment" and at the high end by "extreme problem / definitely needs treatment." Visual analogue ratings for each subscale were converted to 0 to 6 scales with higher values indicating greater impairment and lower values indicating less impairment for each subscale.Within subject comparison of no medication baseline vs. optimal dose medication.

  • Sheehan Disability Scale (SDS) [ Time Frame: baseline and week 4 ] [ Designated as safety issue: No ]
    The SDS consists of 3 self rated items assessing the degree to which symptoms affect work/school, social life, and family/home responsibilities. Items are rated on a 0 (not at all) to 10 (extremely) scale. Items were averaged into an overall disability score with range of 0 to 10 with higher scores indicating more severe disability.Within subject comparison of no medication baseline vs. optimal dose medication.

  • Dyadic Parent-Child Interaction Coding System (DPICS) [ Time Frame: weeks 4 and weeks 5 (period I within subjects trial) ] [ Designated as safety issue: No ]
    Observations of parents and children as they interact with each other during a five minute homework task and during a 10 minute non-academic task. Interactions were recorded and later coded by trained observers. Observers counted number of parent and child behaviors with each parent-child dyad counted as one participant. Average number of behaviors per group were computed.This outcome was part of period I- the within subject comparison of all participating subjects once on placebo (n=26) and once with all subjects on active medication (N=26). (the 27th participant completed this phase but partial data was lost due to mechanical failure with video equipment so their data was not included). All adult participants received both placebo and active medication in this phase that comprised all of period 1.

  • Dyadic Parent-Child Interaction Coding System (DPICS) - Behavior Percentages [ Time Frame: weeks 4 and weeks 5 (period I within subjects trial) ] [ Designated as safety issue: No ]
    Observations of parents and children as they interact with each other during a five minute homework task and during a 10 minute non-academic task. Interactions were recorded and later coded by trained observers. Observers counted number of parent and child behaviors with each parent-child dyad counted as one participant. Percentages of behaviors as a function of total verbalizations (for praise, negative talk, demanding) or as a function of commands and questions (for impatient and responsive) were computed. This outcome was part of period I- the within subject comparison of all participating subjects once on placebo (n=26) and once with all subjects on active medication (N=26). (the 27th participant completed this phase but partial data was lost due to mechanical failure with video equipment so their data was not included). All adult participants received both placebo and active medication in this phase that comprised all of period 1.

  • Pittsburgh Side Effect Rating Scale [ Time Frame: baseline and end of dose optimization phase/week 4 ] [ Designated as safety issue: Yes ]
    rates 13 potential adverse events of central nervous system stimulant medications on a 0-3 likert scale with 0=none 1=mild severity, 2=moderate severity, 3=severe severity. Form completed by participants at end of med optimization phase. Mean severity rating then averaged across 13 categories. This compares mean side effect severity at unmedicated baseline state vs. on optimal dose at week 3. Analysis includes all participants completing medication optimization.

  • Adult ADHD Rating Scale (ADHD RS) [ Time Frame: study endpoint- end of period II (between subjects trial) ] [ Designated as safety issue: No ]
    measures change in all DSM (Diagnostic and Statistics Manual) IV ADHD symptoms on a 0 (least severe) to 3 (most severe) scale. Inattention and hyperactive/impulsive subscales each consist of 9 items with range of 0 to 27. Total Score consists of all 18 items rated 0 to 3 with range of 0 to 54. For all, higher scores indicate more symptoms. All information obtained during clinician interview of patient. At endpoint, the medication group (N=11) was compared to the placebo group (N=13).

  • Parenting Stress Index (PSI)--Total Stress [ Time Frame: study endpoint- end of period II (between subjects trial) ] [ Designated as safety issue: No ]
    measures change in stress of parent child interactions and completed by the participant. The PSI is a measure of the source and degree of parenting stress (Abidin, 1995), which contains 120 items which are rated on a 1 (strongly disagree) to 5 (strongly agree) scale. 101 of these items are used to compute a total stress score (reported below) as the other 19 report on specific life stressors. Range is 101 to 505, for which higher scores indicate higher levels of stress. At endpoint, the medication group (N=9) was compared to the placebo group (N=13).

  • Parenting Locus of Control (PLC) [ Time Frame: study endpoint- end of period II (between subjects trial) ] [ Designated as safety issue: No ]
    self completed parenting measure of the degree to which parents feel they can influence their child's behavior. Measure consists of 25 items each rated using a Likert scales that ranges from 1 ("strongly disagree") to 5 ("strongly agree"). Range is 25 to 125 with higher scores indicating greater parental control over their child's behavior (desired outcome). At endpoint, the medication group (N=9) was compared to the placebo group (N=13).

  • Brown Attention Deficit Scale (BAADS) [ Time Frame: study endpoint- end of period II (between subjects trial) ] [ Designated as safety issue: No ]
    Measures executive functioning using 40 items each rated using a Likert Scale that ranges from 0 ("never") to 3 ("almost daily"). Activation, Attention and effort subscales are 9 items each with range of 0-27. Affect scale is 7 items (range 0-21), memory is 6 items (range 0-18) and total score is 40 items (range 0-120). All raw scores are then reported as T scores based on normative data with higher T scores indicating worse executive functioning. At endpoint, the medication group (N=10) was compared to the placebo group (N=13).

  • Social Skills Rating System (SSRS) [ Time Frame: study endpoint- end of period II (between subjects trial) ] [ Designated as safety issue: No ]
    Measures child's interactions with peers and adults. Items rated using Likert scales that range from 0 ("never") to 2 ("often").At week 8, the medication group (N=10) was compared to the placebo group (N=11). There are two subscales: Problem Behaviors (18 items rated between 0-2 for total score range of 0 to 36) and Social Skills (40 items rated 0-2 with range for total score of 0-80). The total scores for these scales are reported as standard scores, with a population mean of 100 and standard deviation of 15. For problem behavior higher scores indicate worse behavior whereas for social skills, higher scores indicate more social (or better behavior).

  • Disruptive Behavior Disorder Rating Scale (DBD) [ Time Frame: study endpoint- end of period II (between subjects trial) ] [ Designated as safety issue: No ]
    measures externalizing symptoms in children.measures externalizing symptoms in children completed by their primary caretaker who was a participant in the study. The DBD (Pelham et al., 1992) assessed DSM symptoms of ADHD, ODD, and CD from 0 (not at all) to 3 (very much). The DBD includes symptoms of DSM-III and DSM-IV ADHD, Oppositional Defiant Disorder (ODD) and Conduct Disorder (CD).At endpoint, the medication group (N=10) was compared to the placebo group (N=12).

  • Impairment Rating Scale (IRS) [ Time Frame: study endpoint- end of period II (between subjects trial) ] [ Designated as safety issue: No ]
    measures global functioning of child rated by the parent who was the participant in the study. The IRS is a 7 item measure that uses visual-analogue scales to evaluate the child's problem level and need for treatment in developmentally important areas, such as peer relationships, adult-child relationships, academic performance. Each subscale including overall severity is scored from 0 (no problem) to 6 (extreme problem) with higher scores indicating more impairment. At endpoint, the medication group (N=10) was compared to the placebo group (N=13).

  • Sheehan Disability Scale (SDS) [ Time Frame: study endpoint- end of period II (between subjects trial) ] [ Designated as safety issue: No ]
    The SDS consists of 3 self rated items assessing the degree to which symptoms affect work/school, social life, and family/home responsibilities. Items are rated on a 0 (not at all) to 10 (extremely) scale. Items were averaged into an overall disability score with range of 0 to 10 with higher scores indicating more severe disability. At endpoint, the medication group (N=9) was compared to the placebo group (N=13).

  • ADHD Severity Clinical Global Impressions Severity Subscale [ Time Frame: study endpoint- end of period II (between subjects trial) ] [ Designated as safety issue: No ]
    clinician rated measure of ADHD symptom severity in adult participants. The severity subscale is scored from 1 (normal) to 7 (extremely ill).At endpoint, the medication group (N=10) was compared to the placebo group (N=13).

  • Barkley Home Situations Questionnaire (HSQ) [ Time Frame: study endpoint- end of period II (between subjects trial) ] [ Designated as safety issue: No ]
    Self completed by adult participants. Measures their child's functioning in the evening by asking them to report whether or not their child had problems in developmentally important areas. Number of problems per child are counted and counts are then averaged for each group with higher numbers representing more problems. At endpoint, the medication group (N=9) was compared to the placebo group (N=10).

  • Pittsburgh Side Effect Rating Scale Mean Severity Rating. [ Time Frame: study endpoint- end of period II (between subjects trial) ] [ Designated as safety issue: Yes ]
    rates 13 potential adverse events of Central Nervous System (CNS) stimulants on a 0-3 likert scale with 0=none 1=mild severity, 2=moderate severity, 3=severe severity. Form completed by participants. Mean severity rating then averaged across 13 categories.At endpoint, the medication group (N=10) was compared to the placebo group (N=13).

  • Resting Blood Pressure [ Time Frame: study endpoint- end of period II (between subjects trial) ] [ Designated as safety issue: Yes ]
    Measured at rest at last assessment visit using an automated blood pressure machine; results reported in mmHG. At endpoint, the medication group (N=9) was compared to the placebo group (N=10).

  • Alabama Parenting Questionnaire (APQ) [ Time Frame: study endpoint- end of period II (between subjects trial) ] [ Designated as safety issue: No ]

    measures change in parenting practices.The APQ is a 42-item measure (each item ranges from 1/always to 5/never) on which parents are asked to indicate the frequency with which they implement the following parenting practices: involvement (10 items range 10-50- higher scores mean more parental involvement), positive parenting (6 items with range of 6 to 30 and higher scores indicate greater use of praise), poor monitoring/supervision (10 items with range of 10 to 50 and higher scores indicate less supervision/monitoring), inconsistent discipline(6 items with range of 6 to 30 and higher scores indicate greater problems with inconsistent discipline), and corporal punishment (3 items with range of 3-15 and greater scores indicate more use of corporal punishment). Items are rated on a 5-point scale, ranging from 1 ("never") to 5 ("always"). Items summed into composite scales.

    At endpoint, the medication group (N=9) was compared to the placebo group (N=13).


  • Impairment Rating Scale (IRS) [ Time Frame: study endpoint- end of period II (between subjects trial) ] [ Designated as safety issue: No ]
    self rated measure of global impairment of adult participants derived from the child IRS. The IRS-A assesses impairment overall and in specific domains, including interpersonal relationships, academic performance, and self-esteem, and includes adult-specific domains of functioning, such as employment and romantic relationships. The IRS-A assesses current problems and need for treatment. Each subscale is rated from 0 (no problem) to 6 (extreme problem).At endpoint, the medication group (N=11) was compared to the placebo group (N=13). Overall Impairment is its own subscale and not a composite score of the others.

  • Weight [ Time Frame: study endpoint- end of period II (between subjects trial) ] [ Designated as safety issue: Yes ]
    Weight measured on calibrated scale; participant measured without shoes or heavy clothing (jackets, sweaters, etc...). reported in kilograms.At endpoint, the medication group (N=9) was compared to the placebo group (N=11).

  • Resting Pulse [ Time Frame: study endpoint- end of period II (between subjects trial) ] [ Designated as safety issue: Yes ]
    measured at last assessment visit when at rest using an automated blood pressure machine; results reported in beats per minute. At endpoint, the medication group (N=8) was compared to the placebo group (N=9).

  • Pittsburgh Side Effects Rating Scale - Percent Present for All Reported Adverse Events Occurring at a Rate of 5% or More [ Time Frame: end of medication optimization phase/week 4 ] [ Designated as safety issue: Yes ]
    Self report of side effects measured during dose titration using the Pittsburgh Side Effects Rating Scale. Consists of 13 items each rated using 0(none) to 3 (severe) scales. Items endorsed as 1 (mild) or above were counted as present. Information on additional adverse events not part of the PSERS was collected by direct interview of the participants. All side effects occurring at a frequency of 5% or more are reported. Initial side effect data is reported for all participants entering pre-randomization med optimization phase who took medication (n=36) vs those formally enrolled (N=27). Also, side effect data for the med titration phase is entered per dose rather than per participant. For example, a person trying the 30, 50 and 70mg dose is entered is entered 4 times (no med as well) vs. just once. This is why baseline N is higher than for other outcomes collected at weeks 4 and 8 where data was only available for those completing the pre-randomization med optimization phase (N=27).

  • Adult ADHD Rating Scale Completed at the End of the Med Optimization Phase [ Time Frame: baseline and end of med optimization phase/week 4 ] [ Designated as safety issue: No ]
    Measures change in all DSM IV ADHD symptoms on a 0 (least severe) to 3 (most severe) scale. All information obtained during clinician interview of patient. Inattention and hyperactive/impulsive subscales each consist of 9 items with range of 0 to 27. Total Score consists of all 18 items (sum of two subscales) rated 0 to 3 with range of 0 to 54. For all, higher scores indicate more symptoms.


Enrollment: 38
Study Start Date: November 2010
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: stimulant medication
blinded lisdexamfetamine at the optimal dose for the individual participant as previously determined during the med optimization portion of the study
Drug: lisdexamfetamine
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
placebo medication identical in appearance to active med
Drug: lisdexamfetamine
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. 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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01127607

Locations
United States, Florida
Florida International University
Miami, Florida, United States, 33199
Sponsors and Collaborators
Florida International University
Investigators
Principal Investigator: James G Waxmonsky, M.D. Florida International University
  More Information

No publications provided by Florida International University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Florida International University
ClinicalTrials.gov Identifier: NCT01127607     History of Changes
Other Study ID Numbers: IITWW#2
Study First Received: May 19, 2010
Results First Received: January 6, 2014
Last Updated: June 10, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Florida International University:
parenting

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

ClinicalTrials.gov processed this record on October 29, 2014