ADHDPERSNCT05299814
Impact of Parental Emotion Regulation on the Treatment of ADHD
A study testing Behavioral Parenting Intervention in people with ADHD, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial summary
Aim: To examine if parental emotion regulation (ER) moderates the response to parent training interventions. H1: Reduced parental ER capacity will predict diminished efficacy for behavioral parent training to improve negative parenting behavior (NPB) and behavior problems in offspring with ADHD. Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- ADHD
- What is being tested?
- Behavioral Parenting Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Apr 2017to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Parent of a child ages 5-12 with ADHD
- Parent must report that the child has at least a mild level of symptoms at home of Oppositional Defiant Disorder (ODD) on the Disruptive Behavior Disorder Rating Scale (DBDRS)
Who cannot join
- Not being the parent of a child ages 5-12 who meets diagnostic criteria for ADHD.
- Non English Speaking
- the child with ADHD has a diagnosis of intellectual delay or has prominent autistic traits
- Another child in the same family participating in this study already
- Parent does not have a smartphone or tablet device to complete EMA ratings or does not reside with child for the majority of the time.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Penn State Health Dept of Psychiatry
Hershey, Pennsylvania, 17033
James Waxmonsky, 7175318646, jwaxmonsky@pennstatehealth.psu.edu
About this study
Official title: The Impact of Parental Emotion Regulation Capacity on Behavioral Treatment for Pediatric ADHD
Aim: To examine if parental emotion regulation (ER) moderates the response to parent training interventions.
H1: Reduced parental ER capacity will predict diminished efficacy for behavioral parent training to improve negative parenting behavior (NPB) and behavior problems in offspring with ADHD.
H2: Increased parental emotional reactivity will predict diminished efficacy for behavioral parent training to improve negative parenting behavior (NPB) and behavior problems in offspring with ADHD.
Read the detailed description
Children ages 5-12 with ADHD and at least a mild level of oppositional behaviors will be enrolled in a single arm study examining the impact of objective and self rated measurements of parental emotion regulation and emotional reactivity to predict the degree of improvement seen in children's oppositional behaviors and negative parenting behaviors and from an evidence based eight session parenting intervention. The program emphasizes attending to positive behavior, contingent rewards for good behaviors and predictable consequences, such as time-out or loss of privilege, for negative behaviors. The primary outcome is change in parent ratings of symptoms of Oppositional Defiant Disorder (ODD) as measured by the Disruptive Behaviors Disorder Rating Scale (DBDRS).Negative parenting behaviors (NPB) will be assessed using the Alabama Parenting Questionnaire which measures five different domains of parenting and has been used in past trials to detect changes in NPB. Measures will be collected at baseline, midpoint and endpoint. Parental ER capacity will be examined as moderators of the treatment effect on children's symptom levels and NPB.
We will employ two measures of parental emotion regulation: self report using the Difficulties with Emotion Regulation Scale (DERS) and the change in amplitude on the late positive potential (LPP) during an emotion regulation task. The total score from the DERS collected at baseline will serve as the self report measure of parental ER. The total score is the sum of the 6 DERS subscales: nonacceptance of emotional responses, difficulties engaging in goal directed behavior, impulse control difficulties, lack of emotional awareness, limited emotion regulation strategies and lack of emotional clarity.
A cognitive reappraisal task completed under EEG monitoring will serve as the neurobiological measurement of emotion regulation capacity. Change in LPP amplitude on this task has been well established as measure of regulatory capacity. The stimulus set will be comprised of 30 unpleasant, high arousing and 30 neutral, low arousing images from the International Affective Picture System (IAPS). The study will consist of 1 block of 90 stimuli with three types of randomly ordered trials within the block. There will be 30 trials each of a "look neutral", "look negative" and "decrease negative" trial (described below). On each trial, participants will first be asked to relax (baseline) prior to seeing a cue word for 2 seconds on the screen telling them either to "look" or "decrease." After the cue word, a fixation cross to orient visual attention is shown for 500ms, followed by the stimulus for 6 seconds. After each picture, participants will rate their level of arousal on a 0-7 likert. There will be a 2.5 second pause between trials. Prior to data collection, there will be two practice blocks. In the first, participants are given explicit instructions on what to do during the look and decrease trials, with examples of appropriate reappraisal. For 5 practice trials, they will be given detailed feedback on their appraisal efforts. The second practice will consist of 10 trials mimicking the exact procedures for the real task (no feedback). Emotion regulation capacity will be defined as the change in the LPP amplitude between the "look negative" and "decrease negative" trials, with "look neutral" vs look negative" serving as reference comparison to measure the participants' reactivity to emotional stimuli. Total task time is estimated to be 20-22 minutes. On the "decrease negative" trials, participants will be advised to create a positive frame for the story in order to feel negative emotions less strongly. For example, if shown a picture of a corpse, one could imagine that a crime had been solved preventing future murders. In the "look negative" trials, participants will be advised not to perform any reappraisal and simply rate the picture as they see it. In all trials, participants will be instructed only to think about the picture and not to intentionally distract themselves.
Electroencephalogram (EEG) data will be recorded using a 32-channel BrainProducts actiCHamp system and BrainVision Recorder software with electrodes placed over the left and right mastoids as reference electrodes, and above and below the eyes to measure the electrooculogram. The EEG signal will be digitized at 24-bit resolution and sampled at 500 Hz. Data will be processed using BrainVision Analyzer software, and segmented 200ms prior to stimulus onset and continuing for the 6 sec stimulus duration. Data will be referenced to the mastoid averages, filtered from .01 to 30 Hz, and corrected for artifacts. Event-related brain potentials (ERPs) will be constructed by separately averaging "look neutral", "look negative" and "decrease negative" trials for each recording site. The average activity in the 200ms window prior to cue onset will be the baseline. LPP amplitude will be defined as the average amplitude at central-parietal electrodes where LPP is maximal. Consistent with prior work and to evaluate changes in LPP across time as a function of reappraisal, LPP will be examined in in frontal and parietal sites at early (400 to 700ms after image onset), middle (700 to 1000ms) and late (1000 to 6000ms) time windows. Mean LPP amplitudes will be exported from BrainVision and evaluated with SPSS.
After completing this task, participants will also complete the Emotional Faces Task while undergoing EEG assessment using the same EEG techniques and ERP outcomes described above to measure the neurophysiological response to emotions (emotional reactivity). During the task, participants will view images of children with angry or neutral emotional expressions from the NIMH child faces stimulus set or pixelated faces in which the expression is unclear. Following the emotional face, an arrow (< or >) briefly appears on the screen and participants are instructed to press a mouse button to correspond with the direction of the arrows in order to ensure participants are attending to the images. Finally, the same emotional face is presented briefly so that the arrow appears between presentations of the same stimulus. Participants will first complete a brief practice block and then will view complete the emotional faces task. Consistent with prior work measuring reactivity to facial stimuli, LPP change between angry and pixleated faces will be examined in in occipital and parietal sites between 300 to 1000ms after image onset.
This study will examine if parental emotion regulation capacity is associated with the degree of symptomatic improvement in children's oppositional behaviors and negative parenting behaviors (NPB) following a course of behavioral parent training, and whether this association is moderated by parent emotional regulation or parent emotional reactivity. It is hypothesized the association between negative parenting behaviors will be more strongly associated with negative child behavior for parents with lower capacities for emotion regulation (as measured by smaller changes in LPP amplitude/higher scores on the DERS). This hypothesis will be tested by computing multilevel model, with treatment (pre, post) as the level 1 (within-subjects) predictor and parent ER as the level-2 (between-subjects) predictors, along with parent and child demographics as covariates. Separate analyses will be conducted for child and parent outcomes. Analyses will then be repeated using the objective measure of parental emotional reactivity (LPP amplitude change during the faces task) as the moderator in place of parental emotional regulation capacity.
- Conditions
- ADHD
- Being tested
- Behavioral Parenting Intervention
- Keywords
- oppositional behaviors, conduct problems
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral Parenting InterventionBehavioural
8 session evidence based parenting intervention
| Study group | Role | What they receive |
|---|---|---|
| Behavior Therapy | Experimental | 8 sessions of an evidence based parenting program to address oppositional behaviors and ADHD symptoms at home. All participants are in this arm. Receives: Behavioral: Behavioral Parenting Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Oppositional Defiant Disorder Symptoms (change from baseline to endpoint)
This will be measured using parent ratings of symptoms of Oppositional Defiant Disorder as rated on the Disruptive Behavior Disorder Rating Scale (DBD-RS). The Oppositional Behavior subscale on the DBD-RS measures 8 items rated 0-3. Items are averaged to create a mean total score between 0-3. Higher scores indicate greater impairment and worse outcomes.
Measured: baseline (week 0 prior to first therapy session), endpoint (after 8th therapy session which on average is 12 weeks later ))
Secondary outcomes (9)
Change in ADHD symptoms (change from baseline to endpoint)
This will be measured using parent ratings of symptoms of ADHD as rated on the Disruptive Behavior Disorder Rating Scale. The ADHD symptom subscale on the DBD-RS has 18 items rated 0-3 that are averaged to create a mean total score (0-3). Higher scores indicate greater impairment and worse outcomes.
Measured: baseline (week 0 prior to first therapy session), endpoint (after 8th therapy session which on average is 12 weeks later ))
Change in Conduct Disorder Symptoms (change from baseline to endpoint)
This will be measured using parent ratings of symptoms of Conduct Disorder as rated on the Disruptive Behavior Disorder Rating Scale (DBD-RS). The Conduct Disorder subscale on the DBD-RS conduct scale has 15 items rated 0-3 that are averaged to create a mean total score (0-3). Higher scores indicate greater impairment and worse outcomes.
Measured: baseline (week 0 prior to first therapy session), endpoint (after 8th therapy session which on average is 12 weeks later ))
Change in Irritability symptoms (change from baseline to endpoint)
This will be measured using parent ratings of symptoms of irritability as rated on the Disruptive Behavior Disorder Rating Scale (DBD-RS). The Irritability symptom subscale on the DBD-RS has 3 items rated 0-3. They are averaged to create a mean total symptom score (0-3). Higher scores indicate greater impairment and worse outcomes.
Measured: baseline (week 0 prior to first therapy session), endpoint (after 8th therapy session which on average is 12 weeks later ))
Change in rates of Poor Monitoring from Baseline (before therapy) to Endpoint (after last therapy session)
This will be measured using parent self-report ratings of poor monitoring as rated on the Alabama Parenting Questionnaire (APQ). The Poor Monitoring subscale on the APQ has 10 items rated 1-5. They are summed to create a total score. Higher scores indicate greater impairment and worse outcomes.
Measured: baseline (week 0 prior to first therapy session), endpoint (after 8th therapy session which on average is 12 weeks later ))
Change from Baseline (before therapy) Inconsistent Discipline at Endpoint (after last therapy session)
This will be measured using parent self-report ratings of inconsistent discipline as rated on the Alabama Parenting Questionnaire (APQ). The Inconsistent Discipline subscale on the APQ has 6 items rated 1-5. Scores from each item are summed to create a total score. Higher scores indicate greater impairment and worse outcomes.
Measured: baseline (week 0 prior to first therapy session), endpoint (after 8th therapy session which on average is 12 weeks later ))
Change from Baseline (before therapy) Corporal Punishment at Endpoint (after last therapy session)
This will be measured using parent self-report ratings of corporal punishment as rated on the Alabama Parenting Questionnaire (APQ). This subscale on the APQ has 3 items rated 1-5. Scores from each item are summed to create a total score. Higher scores indicate greater impairment and worse outcomes.
Measured: baseline (week 0 prior to first therapy session), endpoint (after 8th therapy session which on average is 12 weeks later ))
Change from Baseline (before therapy) Parental Involvement at Endpoint (after last therapy session)
This will be measured using parent self-report ratings of parental involvement as rated on the Alabama Parenting Questionnaire (APQ). The Poor Monitoring subscale on the APQ has 10 items rated 1-5. Scores from each item are summed to create a total score. Higher scores indicate greater impairment and worse outcomes.
Measured: baseline (week 0 prior to first therapy session), endpoint (after 8th therapy session which on average is 12 weeks later ))
Change from Baseline (before therapy) Positive Parenting at Endpoint (after last therapy session)
This will be measured using parent self-report ratings of positive parenting as rated on the Alabama Parenting Questionnaire (APQ). This subscale on the APQ has 6 items rated 1-5. Scores from each item are summed to create a total score. Higher scores indicate greater impairment and worse outcomes.
Measured: baseline (week 0 prior to first therapy session), endpoint (after 8th therapy session which on average is 12 weeks later ))
Change from Baseline (before therapy) Overall Impairment at Endpoint (after last therapy session)
This will be measured using parent ratings of overall impairment as rated on the Impairment Rating Scale (IRS). The Overall Impairment subscale on the IRS has a minimum score of 0 and maximum score of 6. Higher scores indicate greater impairment and worse outcomes.
Measured: baseline (week 0 prior to first therapy session), endpoint (after 8th therapy session which on average is 12 weeks later ))
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2022
- Study start13 Apr 2017
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADHDStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- single group open label design
- Masking
- None (open label)
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James Waxmonsky, Milton S. Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05299814
- Sponsor's protocol ID
- PERS
- Acronym
- PERS
- Status last verified
- Sep 2026
- First submitted
- 10 Feb 2022
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Parental Emotion Regulation Capacity on Behavioral Treatment for Pediatric ADHD
- ClinicalTrials.gov ID
- NCT05299814
- Acronym / sponsor ID
- PERS / PERS
- Conditions
- ADHD
- Keywords
- oppositional behaviors, conduct problems
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- 13 Apr 2017 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 29 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Aim: To examine if parental emotion regulation (ER) moderates the response to parent training interventions.
H1: Reduced parental ER capacity will predict diminished efficacy for behavioral parent training to improve negative parenting behavior (NPB) and behavior problems in offspring with ADHD.
H2: Increased parental emotional reactivity will predict diminished efficacy for behavioral parent training to improve negative parenting behavior (NPB) and behavior problems in offspring with ADHD.
Detailed description
Children ages 5-12 with ADHD and at least a mild level of oppositional behaviors will be enrolled in a single arm study examining the impact of objective and self rated measurements of parental emotion regulation and emotional reactivity to predict the degree of improvement seen in children's oppositional behaviors and negative parenting behaviors and from an evidence based eight session parenting intervention. The program emphasizes attending to positive behavior, contingent rewards for good behaviors and predictable consequences, such as time-out or loss of privilege, for negative behaviors. The primary outcome is change in parent ratings of symptoms of Oppositional Defiant Disorder (ODD) as measured by the Disruptive Behaviors Disorder Rating Scale (DBDRS).Negative parenting behaviors (NPB) will be assessed using the Alabama Parenting Questionnaire which measures five different domains of parenting and has been used in past trials to detect changes in NPB. Measures will be collected at baseline, midpoint and endpoint. Parental ER capacity will be examined as moderators of the treatment effect on children's symptom levels and NPB.
We will employ two measures of parental emotion regulation: self report using the Difficulties with Emotion Regulation Scale (DERS) and the change in amplitude on the late positive potential (LPP) during an emotion regulation task. The total score from the DERS collected at baseline will serve as the self report measure of parental ER. The total score is the sum of the 6 DERS subscales: nonacceptance of emotional responses, difficulties engaging in goal directed behavior, impulse control difficulties, lack of emotional awareness, limited emotion regulation strategies and lack of emotional clarity.
A cognitive reappraisal task completed under EEG monitoring will serve as the neurobiological measurement of emotion regulation capacity. Change in LPP amplitude on this task has been well established as measure of regulatory capacity. The stimulus set will be comprised of 30 unpleasant, high arousing and 30 neutral, low arousing images from the International Affective Picture System (IAPS). The study will consist of 1 block of 90 stimuli with three types of randomly ordered trials within the block. There will be 30 trials each of a "look neutral", "look negative" and "decrease negative" trial (described below). On each trial, participants will first be asked to relax (baseline) prior to seeing a cue word for 2 seconds on the screen telling them either to "look" or "decrease." After the cue word, a fixation cross to orient visual attention is shown for 500ms, followed by the stimulus for 6 seconds. After each picture, participants will rate their level of arousal on a 0-7 likert. There will be a 2.5 second pause between trials. Prior to data collection, there will be two practice blocks. In the first, participants are given explicit instructions on what to do during the look and decrease trials, with examples of appropriate reappraisal. For 5 practice trials, they will be given detailed feedback on their appraisal efforts. The second practice will consist of 10 trials mimicking the exact procedures for the real task (no feedback). Emotion regulation capacity will be defined as the change in the LPP amplitude between the "look negative" and "decrease negative" trials, with "look neutral" vs look negative" serving as reference comparison to measure the participants' reactivity to emotional stimuli. Total task time is estimated to be 20-22 minutes. On the "decrease negative" trials, participants will be advised to create a positive frame for the story in order to feel negative emotions less strongly. For example, if shown a picture of a corpse, one could imagine that a crime had been solved preventing future murders. In the "look negative" trials, participants will be advised not to perform any reappraisal and simply rate the picture as they see it. In all trials, participants will be instructed only to think about the picture and not to intentionally distract themselves.
Electroencephalogram (EEG) data will be recorded using a 32-channel BrainProducts actiCHamp system and BrainVision Recorder software with electrodes placed over the left and right mastoids as reference electrodes, and above and below the eyes to measure the electrooculogram. The EEG signal will be digitized at 24-bit resolution and sampled at 500 Hz. Data will be processed using BrainVision Analyzer software, and segmented 200ms prior to stimulus onset and continuing for the 6 sec stimulus duration. Data will be referenced to the mastoid averages, filtered from .01 to 30 Hz, and corrected for artifacts. Event-related brain potentials (ERPs) will be constructed by separately averaging "look neutral", "look negative" and "decrease negative" trials for each recording site. The average activity in the 200ms window prior to cue onset will be the baseline. LPP amplitude will be defined as the average amplitude at central-parietal electrodes where LPP is maximal. Consistent with prior work and to evaluate changes in LPP across time as a function of reappraisal, LPP will be examined in in frontal and parietal sites at early (400 to 700ms after image onset), middle (700 to 1000ms) and late (1000 to 6000ms) time windows. Mean LPP amplitudes will be exported from BrainVision and evaluated with SPSS.
After completing this task, participants will also complete the Emotional Faces Task while undergoing EEG assessment using the same EEG techniques and ERP outcomes described above to measure the neurophysiological response to emotions (emotional reactivity). During the task, participants will view images of children with angry or neutral emotional expressions from the NIMH child faces stimulus set or pixelated faces in which the expression is unclear. Following the emotional face, an arrow (< or >) briefly appears on the screen and participants are instructed to press a mouse button to correspond with the direction of the arrows in order to ensure participants are attending to the images. Finally, the same emotional face is presented briefly so that the arrow appears between presentations of the same stimulus. Participants will first complete a brief practice block and then will view complete the emotional faces task. Consistent with prior work measuring reactivity to facial stimuli, LPP change between angry and pixleated faces will be examined in in occipital and parietal sites between 300 to 1000ms after image onset.
This study will examine if parental emotion regulation capacity is associated with the degree of symptomatic improvement in children's oppositional behaviors and negative parenting behaviors (NPB) following a course of behavioral parent training, and whether this association is moderated by parent emotional regulation or parent emotional reactivity. It is hypothesized the association between negative parenting behaviors will be more strongly associated with negative child behavior for parents with lower capacities for emotion regulation (as measured by smaller changes in LPP amplitude/higher scores on the DERS). This hypothesis will be tested by computing multilevel model, with treatment (pre, post) as the level 1 (within-subjects) predictor and parent ER as the level-2 (between-subjects) predictors, along with parent and child demographics as covariates. Separate analyses will be conducted for child and parent outcomes. Analyses will then be repeated using the objective measure of parental emotional reactivity (LPP amplitude change during the faces task) as the moderator in place of parental emotional regulation capacity.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- single group open label design
| Arm | Type | Receives |
|---|---|---|
| Behavior Therapy | Experimental | Behavioral: Behavioral Parenting Intervention8 sessions of an evidence based parenting program to address oppositional behaviors and ADHD symptoms at home. All participants are in this arm. |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Parent of a child ages 5-12 with ADHD
- Parent must report that the child has at least a mild level of symptoms at home of Oppositional Defiant Disorder (ODD) on the Disruptive Behavior Disorder Rating Scale (DBDRS)
Key exclusion criteria (5 listed)
- Not being the parent of a child ages 5-12 who meets diagnostic criteria for ADHD.
- Non English Speaking
- the child with ADHD has a diagnosis of intellectual delay or has prominent autistic traits
- Another child in the same family participating in this study already
- Parent does not have a smartphone or tablet device to complete EMA ratings or does not reside with child for the majority of the time.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral Parenting Intervention8 session evidence based parenting intervention | Behavioural | Behavior Therapy |
Primary outcome
Change in Oppositional Defiant Disorder Symptoms (change from baseline to endpoint)
Time frame: baseline (week 0 prior to first therapy session), endpoint (after 8th therapy session which on average is 12 weeks later ))
This will be measured using parent ratings of symptoms of Oppositional Defiant Disorder as rated on the Disruptive Behavior Disorder Rating Scale (DBD-RS). The Oppositional Behavior subscale on the DBD-RS measures 8 items rated 0-3. Items are averaged to create a mean total score between 0-3. Higher scores indicate greater impairment and worse outcomes.
9 secondary outcomes
Change in ADHD symptoms (change from baseline to endpoint)
Time frame: baseline (week 0 prior to first therapy session), endpoint (after 8th therapy session which on average is 12 weeks later ))
Change in Conduct Disorder Symptoms (change from baseline to endpoint)
Time frame: baseline (week 0 prior to first therapy session), endpoint (after 8th therapy session which on average is 12 weeks later ))
Change in Irritability symptoms (change from baseline to endpoint)
Time frame: baseline (week 0 prior to first therapy session), endpoint (after 8th therapy session which on average is 12 weeks later ))
Change in rates of Poor Monitoring from Baseline (before therapy) to Endpoint (after last therapy session)
Time frame: baseline (week 0 prior to first therapy session), endpoint (after 8th therapy session which on average is 12 weeks later ))
Change from Baseline (before therapy) Inconsistent Discipline at Endpoint (after last therapy session)
Time frame: baseline (week 0 prior to first therapy session), endpoint (after 8th therapy session which on average is 12 weeks later ))
Change from Baseline (before therapy) Corporal Punishment at Endpoint (after last therapy session)
Time frame: baseline (week 0 prior to first therapy session), endpoint (after 8th therapy session which on average is 12 weeks later ))
Change from Baseline (before therapy) Parental Involvement at Endpoint (after last therapy session)
Time frame: baseline (week 0 prior to first therapy session), endpoint (after 8th therapy session which on average is 12 weeks later ))
Change from Baseline (before therapy) Positive Parenting at Endpoint (after last therapy session)
Time frame: baseline (week 0 prior to first therapy session), endpoint (after 8th therapy session which on average is 12 weeks later ))
Change from Baseline (before therapy) Overall Impairment at Endpoint (after last therapy session)
Time frame: baseline (week 0 prior to first therapy session), endpoint (after 8th therapy session which on average is 12 weeks later ))
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Parenting Intervention in people with ADHD, run by Milton S. Hershey Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact James G Waxmonsky, MD (7175318646, jwaxmonsky@pennstatehealth.psu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Oppositional Defiant Disorder Symptoms (change from baseline to endpoint) (time frame: baseline (week 0 prior to first therapy session), endpoint (after 8th therapy session which on average is 12 weeks later ))). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.