Impact of Parental Emotion Regulation on the Treatment of ADHD
ConditionADHD
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-12
SponsorMilton S. Hershey Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Behavioral Parenting Intervention
Behavioral8 session evidence based parenting intervention
Treatment groups
65 Participants
are divided into 1 treatment groupGroup A: Behavior TherapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
baseline (week 0 prior to first therapy session), endpoint (after 8th therapy session which on average is 12 weeks later ))Secondary outcomes
1
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.
Time frame
baseline (week 0 prior to first therapy session), endpoint (after 8th therapy session which on average is 12 weeks later ))2
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.
Time frame
baseline (week 0 prior to first therapy session), endpoint (after 8th therapy session which on average is 12 weeks later ))3
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.
Time frame
baseline (week 0 prior to first therapy session), endpoint (after 8th therapy session which on average is 12 weeks later ))4
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.
Time frame
baseline (week 0 prior to first therapy session), endpoint (after 8th therapy session which on average is 12 weeks later ))Sponsors and contacts
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Source ClinicalTrials.gov