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

NCT01127607 | Completed Phase 4 Results

• 1 other identifier: IITWW#2
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

ADHD

Keywords

parenting

Outcome Measures

Primary Outcomes (2)

• Dyadic Parent-Child Interaction Coding System (DPICS) - Behavior Counts

  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).

  study endpoint- end of period II (between subjects trial)

• Dyadic Parent-Child Interaction Coding System (DPICS) - Behavior Percentages

  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).

  study endpoint- end of period II (between subjects trial)

Secondary Outcomes (25)

• Alabama Parenting Questionnaire (APQ)

  baseline and week 4

• Disruptive Behavior Disorders Rating Scale (DBD)

  baseline and week 4

• Impairment Rating Scale (IRS)

  baseline and week 4

• Sheehan Disability Scale (SDS)

  baseline and week 4

• Dyadic Parent-Child Interaction Coding System (DPICS)

  weeks 4 and weeks 5 (period I within subjects trial)

Study Arms (2)

stimulant medication

EXPERIMENTAL

blinded lisdexamfetamine at the optimal dose for the individual participant as previously determined during the med optimization portion of the study

Drug: lisdexamfetamine

placebo pill

PLACEBO COMPARATOR

placebo medication identical in appearance to active med

Drug: lisdexamfetamine

Interventions

lisdexamfetamine DRUG

3 week with-in subject lead in phase to find optimal dose ranging from 30 mg to 70mg

Also known as: vyvanse

placebo pill; stimulant medication

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Florida International University: lead

Study Sites (1)

Florida International University

Miami, Florida, 33199, United States

Location

Related Publications (2)

• 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.

  PMID: 27991835 DERIVED

• 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.

  PMID: 24796970 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Lisdexamfetamine Dimesylate

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Dextroamphetamine; Amphetamine; Amphetamines; Phenethylamines; Ethylamines; Amines; Organic Chemicals

Limitations and Caveats

This study was limited by its small sample size. The validity and psychometrics of DPICS in adolescents is not well established, but removal of the adolescents had little impact on study results and actually strengthened some observed effects.

Results Point of Contact

• Title: Dr. James Waxmonsky
• Organization: Florida International University

jwaxmons@fiu.edu

717 531 8646

Study Officials

• James G Waxmonsky, M.D.

  Florida International University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2010
• First Posted: May 21, 2010
• Study Start: November 1, 2010
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: June 13, 2014
• Results First Posted: June 13, 2014

Record last verified: 2014-06

Locations

US (1)