Trial · NCT01127607
Does Pharmacological Treatment of Attention Deficit Hyperactivity Disorder (ADHD) in Adults Enhance Parenting Performance?
NCT01127607, Phase 4, Completed, Florida International University; results first posted 2014-06-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Does Pharmacological Treatment of Attention Deficit Hyperactivity Disorder (ADHD) in Adults Enhance Parenting Performance? Trials, record NCT01127607. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01127607
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Does Pharmacological Treatment of Attention Deficit Hyperactivity Disorder (ADHD) in Adults Enhance Parenting Performance?
- NCT number
- NCT01127607
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 38 participants, actual
- Lead sponsor
- Florida International University
- Conditions
- ADHD
- Interventions
- lisdexamfetamine
- First posted
- 2010-05-21
- Last updated
- 2014-06-13
- Results first posted
- 2014-06-13
- 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.
Source ClinicalTrials.gov
Registered outcomes27
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Dyadic Parent-Child Interaction Coding System (DPICS) - Behavior Counts | study endpoint- end of period II (between subjects trial) | 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). |
| Primary | Dyadic Parent-Child Interaction Coding System (DPICS) - Behavior Percentages | study endpoint- end of period II (between subjects trial) | 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 | Alabama Parenting Questionnaire (APQ) | baseline and week 4 | 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. |
| Secondary | Disruptive Behavior Disorders Rating Scale (DBD) | baseline and week 4 | 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. |
| Secondary | Impairment Rating Scale (IRS) | baseline and week 4 | 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. |
| Secondary | Sheehan Disability Scale (SDS) | baseline and week 4 | 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. |
| Secondary | Dyadic Parent-Child Interaction Coding System (DPICS) | weeks 4 and weeks 5 (period I within subjects trial) | 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. |
| Secondary | Dyadic Parent-Child Interaction Coding System (DPICS) - Behavior Percentages | weeks 4 and weeks 5 (period I within subjects trial) | 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. |
| Secondary | Pittsburgh Side Effect Rating Scale | baseline and end of dose optimization phase/week 4 | 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. |
| Secondary | Adult ADHD Rating Scale (ADHD RS) | study endpoint- end of period II (between subjects trial) | 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). |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 registered outcomesOutcomes27
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| SECONDARY | Alabama Parenting Questionnaire (APQ) | baseline and week 4 | Used a within-subjects evaluation; the same 24 participants evaluated in both arms. | units on a scale | MEAN |
| SECONDARY | Disruptive Behavior Disorders Rating Scale (DBD) | baseline and week 4 | Used a within-subjects design; the same 24 participants measured in both arms. | units on a scale | MEAN |
| SECONDARY | Impairment Rating Scale (IRS) | baseline and week 4 | Uses a within-subjects evaluation; the same 25 participants are in both arms. | units on a 0 to 6 scale | MEAN |
| SECONDARY | Sheehan Disability Scale (SDS) | baseline and week 4 | Uses a within-subjects design; the same 25 participants are in both arms. | units on a 0 to 10 scale | MEAN |
| SECONDARY | Dyadic Parent-Child Interaction Coding System (DPICS) | weeks 4 and weeks 5 (period I within subjects trial) | Used a within-subjects design for this phase; the same 26 participants completed all four arms. | behaviors | MEAN |
| SECONDARY | Dyadic Parent-Child Interaction Coding System (DPICS) - Behavior Percentages | weeks 4 and weeks 5 (period I within subjects trial) | Used a within-subjects design; the same 26 participants completed all arms. | Percentage of behaviors | MEAN |
| SECONDARY | Pittsburgh Side Effect Rating Scale | baseline and end of dose optimization phase/week 4 | Within-subjects analysis; same 26 participants are in the unmedicated and optimal dose of medication arms. | units on a scale | MEAN |
| SECONDARY | Adult ADHD Rating Scale (ADHD RS) | study endpoint- end of period II (between subjects trial) | units on a scale | MEAN | |
| SECONDARY | Parenting Stress Index (PSI)--Total Stress | study endpoint- end of period II (between subjects trial) | units on a scale | MEAN | |
| SECONDARY | Parenting Locus of Control (PLC) | study endpoint- end of period II (between subjects trial) | units on a scale | MEAN |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 outcomesResults by group244
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Alabama Parenting Questionnaire (APQ) | Unmedicated | Parent Involvement | 37.83 | Standard Deviation 5.64 | units on a scale |
| Alabama Parenting Questionnaire (APQ) | Optimal Dose of Medication | Parent Involvement | 38.82 | Standard Deviation 5.30 | units on a scale |
| Alabama Parenting Questionnaire (APQ) | Unmedicated | Positive parenting | 25.42 | Standard Deviation 3.60 | units on a scale |
| Alabama Parenting Questionnaire (APQ) | Optimal Dose of Medication | Positive parenting | 25.58 | Standard Deviation 2.86 | units on a scale |
| Alabama Parenting Questionnaire (APQ) | Unmedicated | Poor monitoring and poor supervision | 14.25 | Standard Deviation 3.84 | units on a scale |
| Alabama Parenting Questionnaire (APQ) | Optimal Dose of Medication | Poor monitoring and poor supervision | 13.58 | Standard Deviation 3.20 | units on a scale |
| Alabama Parenting Questionnaire (APQ) | Unmedicated | Inconsistent discipline | 15.79 | Standard Deviation 3.51 | units on a scale |
| Alabama Parenting Questionnaire (APQ) | Optimal Dose of Medication | Inconsistent discipline | 14.62 | Standard Deviation 3.87 | units on a scale |
| Alabama Parenting Questionnaire (APQ) | Unmedicated | Corporal punishment | 4.79 | Standard Deviation 2.04 | units on a scale |
| Alabama Parenting Questionnaire (APQ) | Optimal Dose of Medication | Corporal punishment | 4.42 | Standard Deviation 1.72 | units on a scale |
1 to 10 of 244Source ClinicalTrials.gov
See all 244 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Phase I (Within Subjects) | STARTED | Placebo Arm | 14 | |
| Phase I (Within Subjects) | STARTED | Treatment Arm | 13 | |
| Phase I (Within Subjects) | COMPLETED | Placebo Arm | 14 | |
| Phase I (Within Subjects) | COMPLETED | Treatment Arm | 13 | |
| Phase I (Within Subjects) | NOT COMPLETED | Placebo Arm | 0 | |
| Phase I (Within Subjects) | NOT COMPLETED | Treatment Arm | 0 | |
| Phase II (Between Subjects) | STARTED | Placebo Arm | 14 | |
| Phase II (Between Subjects) | STARTED | Treatment Arm | 13 | |
| Phase II (Between Subjects) | COMPLETED | Placebo Arm | 13 | |
| Phase II (Between Subjects) | COMPLETED | Treatment Arm | 11 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events80
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Buccal Lingual Movements | Nervous system disorders | Placebo Arm | 2 | 13 | 2 |
| other | Buccal Lingual Movements | Nervous system disorders | Treatment Arm | 0 | 13 | 0 |
| other | Buccal Lingual Movements | Nervous system disorders | All Participants in Period 1 Prescribed 30mg | 7 | 36 | 7 |
| other | Buccal Lingual Movements | Nervous system disorders | All Participants in Period 1 Prescribed 50mg | 6 | 21 | 6 |
| other | Buccal Lingual Movements | Nervous system disorders | All Participants in Period 1 Prescribed 70mg | 4 | 17 | 4 |
| other | picking at skin | Nervous system disorders | Placebo Arm | 2 | 13 | 2 |
| other | picking at skin | Nervous system disorders | Treatment Arm | 0 | 13 | 0 |
| other | picking at skin | Nervous system disorders | All Participants in Period 1 Prescribed 30mg | 4 | 36 | 4 |
| other | picking at skin | Nervous system disorders | All Participants in Period 1 Prescribed 50mg | 3 | 21 | 3 |
| other | picking at skin | Nervous system disorders | All Participants in Period 1 Prescribed 70mg | 1 | 17 | 1 |
1 to 10 of 80Source ClinicalTrials.gov
See all 80 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo Arm | ||
| Total, all-cause mortality | Treatment Arm | ||
| Total, all-cause mortality | All Participants in Period 1 Prescribed 30mg | ||
| Total, all-cause mortality | All Participants in Period 1 Prescribed 50mg | ||
| Total, all-cause mortality | All Participants in Period 1 Prescribed 70mg | ||
| Total, other adverse events | Placebo Arm | 5 | 13 |
| Total, other adverse events | Treatment Arm | 5 | 13 |
| Total, other adverse events | All Participants in Period 1 Prescribed 30mg | 34 | 36 |
| Total, other adverse events | All Participants in Period 1 Prescribed 50mg | 18 | 21 |
| Total, other adverse events | All Participants in Period 1 Prescribed 70mg | 15 | 17 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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