What side effects are associated with this type of intervention?

Common treatments for ADHD, such as stimulant medications (e.g., methylphenidate and amphetamines), often have side effects including loss of appetite, dry mouth, headaches, and delayed sleep onset. Behavioral interventions like parent training are generally safe but their effectiveness can be influenced by the emotional regulation and mental health of the parents. Addressing parental ADHD symptoms and emotional reactivity is crucial for the success of these interventions.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of ADHD, including psychostimulants like methylphenidate and various amphetamine preparations, as well as non-stimulants such as atomoxetine and guanfacine. These medications are often used in conjunction with behavioral interventions, such as Behavioral Parent Training, which can be moderated by factors like Parental Emotion Regulation. This combined approach aims to manage core ADHD symptoms and improve overall behavioral outcomes.

What other types of research exist?

Promising novel alternatives to Behavioral Parent Training for ADHD patients include: 1) Cognitive-Behavioral Therapy (CBT) combined with pharmacotherapy, which has shown efficacy in managing ADHD symptoms. 2) Mindfulness-based interventions, which can improve parental emotion regulation and reduce stress. 3) Integrative models that combine behavioral, cognitive, and emotional strategies to address multiple domains of function. These approaches can be tailored to individual needs and may offer comprehensive benefits for both children and parents.

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Behavioral Intervention

Behavioral Parenting Intervention for ADHD (PERS Trial)

N/A

Recruiting

Research Sponsored by Milton S. Hershey Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (week 0 prior to first therapy session), endpoint (after 8th therapy session which on average is 12 weeks later ))

Awards & highlights

No Placebo-Only Group

Summary

This trial examines if a parent training program can help children aged 5-12 with ADHD and mild oppositional behaviors. The program teaches parents to manage their children's actions through positive reinforcement and clear consequences. The study will see if parents' ability to control their own emotions affects the program's success.

Who is the study for?

This trial is for parents of children aged 5-12 with ADHD and mild Oppositional Defiant Disorder symptoms. Parents must speak English, have a smartphone or tablet, live with the child most of the time, and not have another child in the study.

What is being tested?

The study tests if how well parents manage their emotions affects the success of behavioral training aimed at improving parenting skills and reducing behavior problems in kids with ADHD.

What are the potential side effects?

Since this is a behavioral intervention focusing on parent training, there are no direct medical side effects. However, participating may temporarily increase stress or emotional discomfort.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (week 0 prior to first therapy session), endpoint (after 8th therapy session which on average is 12 weeks later ))

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (week 0 prior to first therapy session), endpoint (after 8th therapy session which on average is 12 weeks later ))

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (week 0 prior to first therapy session), endpoint (after 8th therapy session which on average is 12 weeks later )) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Oppositional Defiant Disorder Symptoms (change from baseline to endpoint)

Secondary study objectives

Change from Baseline (before therapy) Corporal Punishment at Endpoint (after last therapy session)

Change from Baseline (before therapy) Inconsistent Discipline at Endpoint (after last therapy session)

Change from Baseline (before therapy) Overall Impairment at Endpoint (after last therapy session)

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Behavior TherapyExperimental Treatment1 Intervention

8 sessions of an evidence based parenting program to address oppositional behaviors and ADHD symptoms at home. All participants are in this arm.

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for ADHD include pharmacological and behavioral interventions. Stimulant medications like methylphenidate and amphetamines increase dopamine and norepinephrine levels in the brain, improving attention and reducing impulsivity and hyperactivity. Behavioral Parent Training (BPT) teaches parents effective strategies to manage their child's behavior through positive reinforcement and structure. The focus on parental emotion regulation in BPT is essential, as parents with better emotional control can more effectively implement these strategies, leading to better outcomes for children with ADHD. This dual approach addresses both neurological and environmental factors, providing a comprehensive treatment plan.

Bibliotherapy as an adjunct to stimulant medication in the treatment of attention-deficit hyperactivity disorder.Twenty years of research on attention-deficit/hyperactivity disorder (ADHD): looking back, looking forward.Parent training interventions for Attention Deficit Hyperactivity Disorder (ADHD) in children aged 5 to 18 years.