ADHD Medication + Parent Training for ADHD Families

(TPAC Trial)

Not currently recruiting at 1 trial location

Overseen By Andrea M Chronis-Tuscano, Ph.D.

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: University of Maryland, College Park

Must be taking: Stimulants

Must not be taking: Stimulants, Antidepressants

Disqualifiers: Substance abuse, Bipolar, Schizophrenia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of combining medication with parent training for families managing ADHD. One group of parents will receive a stimulant medication (extended-release mixed amphetamine salts) along with behavioral training, while another group will initially receive only the training. The study aims to determine if this combined approach can improve symptoms in both children and parents. Families with children showing signs of ADHD and parents diagnosed with ADHD might be suitable candidates. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on an antidepressant, it must be well-tolerated, unchanged for 30 days, and approved by your doctor for participation. If you have taken stimulant medication for ADHD in the past 30 days, you may not be eligible.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that Behavioral Parent Training (BPT) is safe and effective for families managing ADHD. Studies have found that BPT reduces parenting stress and improves children's behavior without major safety issues. Parents learn skills to help their children succeed at home and in school, which can significantly aid in managing ADHD symptoms.

Research indicates that extended-release mixed amphetamine salts (MAS) are generally well-tolerated by both children and adults with ADHD. Common side effects include trouble sleeping and dry mouth, but these are usually mild. MAS is already approved for treating ADHD, which supports its safety.

Previous research has shown that both treatments in this trial are safe for people with ADHD. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for ADHD because they combine medication and behavioral training in a unique way. Unlike standard treatments that typically focus on either medication or behavioral therapy independently, this approach starts with parent stimulant medication followed by behavioral parent training. If needed, child stimulant medication is introduced next, allowing for a more tailored and potentially effective strategy. This dual focus aims to address ADHD symptoms more comprehensively by involving both parents and children in the treatment process. By doing so, this method could lead to better management of ADHD symptoms and improved family dynamics.

What evidence suggests that this trial's treatments could be effective for ADHD?

Research has shown that behavioral parent training (BPT) effectively reduces ADHD symptoms and related behavior issues in children. Studies indicate that BPT not only alleviates ADHD symptoms but also enhances parenting skills. Meanwhile, extended-release mixed amphetamine salts (MAS) have significantly improved ADHD symptoms. For example, many patients taking MAS experience a noticeable reduction in symptoms, with some studies finding that up to 75% of participants see significant improvement. In this trial, one arm will explore the combination of parent stimulant medication followed by a child treatment strategy involving BPT and potentially child stimulant medication. Another arm will focus on a child treatment strategy with BPT and potentially child stimulant medication, without prior parent stimulant medication. Both BPT and MAS show promising results for managing ADHD symptoms, and using them together might offer even greater benefits. ^{1 6 7 8 9}

Who Is on the Research Team?

Andrea Chronis-Tuscano, Ph.D.

Principal Investigator

University of Maryland, College Park

Are You a Good Fit for This Trial?

This trial is for parents over 21 with ADHD and their children aged 3-8 who may also have ADHD symptoms. Parents must meet full criteria for ADHD, be in good physical health, not pregnant, and agree to use contraception if applicable. Children should not have been on stimulant medications before or only tried them without success.

Inclusion Criteria

Parent: Be at least 21 years old and English-speaking, Meet full DSM-5 criteria for ADHD (any subtype), Have findings on physical examination, laboratory studies, vital signs, and electrocardiogram judged to be normal for age with no contraindications for stimulant medication, Have pulse and blood pressure (BP) within 95% of age and gender mean, Women of childbearing potential agree to use a medically accepted contraception method consistently, Parents with common comorbid conditions will be included provided that: (a) they do not report active suicidal ideation with intent (i.e. Beck Depression Inventory (BDI)-II score of 2 or 3 to Q9 which assesses suicidal thoughts); and (b) if receiving an antidepressant medication, their medication is well-tolerated, has not changed within 30 days, and the prescribing physician approves of their participation in the study, Must have regular access to a computer or phone that can be used to deliver the behavioral parent training

You have a CGI-S-ADHD rating ≥4 and <7.

My child is 3-8 years old, may or may not have tried ADHD meds, and shows significant ADHD symptoms.

Exclusion Criteria

- Parent has had severe negative reactions to study medications in the past or has a history of substance abuse within the last three months. - Parent has bipolar disorder, schizophrenia, psychoses, or other primary psychiatric disorder requiring immediate treatment. - Parent has a chronic or acute medical disorder that makes stimulant therapy unsafe, such as glaucoma or hypertension. - Parent has taken stimulant medication for ADHD within the last 30 days. - Parent is pregnant.

The child has very severe ADHD symptoms with a score of more than 6 on a scale called CGI-S-ADHD.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Parents receive stimulant medication and behavioral parent training, while children receive behavioral parent training with potential recommendation for stimulant medication

16 weeks

Telehealth sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

20 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Behavioral Parent Training
• Extended release mixed amphetamine salts (MAS)

Trial Overview

The study tests if combining a stimulant drug (MAS) for the parent with behavioral training improves child's ADHD-related issues more than just training alone. It will look at how this affects both the child’s behavior and the parent's ADHD symptoms when delivered via telehealth.

How Is the Trial Designed?

Group I: Parent Stimulant Medication + Child Treatment Strategy Experimental Treatment 2 Interventions

Parent stimulant medication first followed by a child treatment strategy consisting of behavioral parent training followed by a recommendation for child stimulant medication to the primary care provider if the child remains impaired.

Group II: Child Treatment Strategy Active Control 1 Intervention

Child treatment strategy consisting of behavioral parent training followed by a recommendation for child stimulant medication to the primary care provider if the child remains impaired. In this arm, parents do not receive stimulant medication before behavioral parent training.

Behavioral Parent Training is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Behavioral Parent Training for:

• Disruptive Behavior Disorder
• Oppositional Defiant Disorder
• Conduct Disorder
• Attention-Deficit/Hyperactivity Disorder (ADHD)
• Anxiety with behavioral difficulties
• Disruptive Mood Dysregulation Disorder (DMDD)
• Intermittent Explosive Disorder (IED)

Approved in European Union as Parent Management Training for:

• Disruptive Behavior Disorder
• Oppositional Defiant Disorder
• Conduct Disorder
• Attention-Deficit/Hyperactivity Disorder (ADHD)
• Anxiety with behavioral difficulties

Approved in Canada as Behavioral Parent Training for:

• Disruptive Behavior Disorder
• Oppositional Defiant Disorder
• Conduct Disorder
• Attention-Deficit/Hyperactivity Disorder (ADHD)

Who Is Running the Clinical Trial?

University of Maryland, College Park

Lead Sponsor

Trials

163

Recruited

46,800+

Children's National Research Institute

Collaborator

Trials

227

Recruited

258,000+

University of Michigan

Collaborator

Trials

1,891

Recruited

6,458,000+

Seattle Children's Hospital

Collaborator

Trials

319

Recruited

5,232,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

A study involving 92 parents of children with ADHD showed that brief training in either antecedent-based (AC) or consequent-based (CC) techniques significantly improved daily problem behaviors compared to a waitlist group.

Antecedent-based techniques were particularly effective in reducing inattention symptoms immediately after training and at a two-week follow-up, highlighting their importance in managing ADHD behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Which Techniques Work in Behavioral Parent Training for Children with ADHD? A Randomized Controlled Microtrial. Hornstra, R., van der Oord, S., Staff, AI., et al.[2022]

A randomized controlled trial involving 56 preschool children with ADHD showed that group-based behavioral parent training (BPT) is as effective as individual BPT in reducing ADHD severity over 12 weeks.

Both group and individual BPT significantly reduced parental stress and improved coping strategies, indicating that group BPT is a feasible and effective treatment option in low-resource settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of brief group behavioural parent training with individual parent training for preschool children with attention deficit hyperactivity disorder: A randomized feasibility study. Vaidyanathan, S., Chandrasekaran, V., Kandasamy, P.[2023]

Behavioral parent training (BPT) significantly reduced the frequency and severity of problematic behaviors in children with ADHD, particularly in areas like chores, homework, and peer interactions, based on data from 304 parents.

Parents reported a notable decrease in stress related to parenting their child with ADHD after participating in BPT, indicating that this intervention not only helps children but also supports parental well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral Parent Training for ADHD Reduces Situational Severity of Child Noncompliance and Related Parental Stress. Ciesielski, HA., Loren, REA., Tamm, L.[2021]

A pilot study involving 35 mothers with ADHD and their children showed that both stimulant medication and behavioral parent training are acceptable and feasible treatments, with mothers preferring combination therapy, especially starting with medication.

The study highlights that treating mothers with ADHD can positively impact their children's ADHD symptoms, suggesting that addressing parental ADHD is a crucial step in improving family health and functioning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Piloting a Sequential, Multiple Assignment, Randomized Trial for Mothers with Attention-Deficit/Hyperactivity Disorder and Their At-Risk Young Children. Schoenfelder, EN., Chronis-Tuscano, A., Strickland, J., et al.[2023]

Behavioral Parent Training (BPT) is an effective first-line treatment for children with ADHD under six years old and a recommended combination treatment for older children, showing significant improvements in problem behaviors like inattention and hyperactivity.

The study demonstrated that BPT significantly improved parenting practices, as evidenced by changes in Parenting Scale scores, indicating that it can reduce negative parenting behaviors and enhance outcomes for children with ADHD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does a Behavioral Parent Training Program for Parents of ADHD Children Improve Outcomes? A Pilot Project. Morgan, TC., O'Keefe, LC.[2021]

Behavioral parent training (BPT) is an effective treatment for ADHD, improving both child behavior and parenting practices, as well as reducing parenting stress and enhancing classroom behavior.

Despite its effectiveness, research on BPT for ADHD is less comprehensive than for other disorders like oppositional defiant disorder (ODD) and conduct disorder (CD), highlighting the need for further studies to understand factors affecting treatment outcomes, especially given the high comorbidity between ADHD and these disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancements to the behavioral parent training paradigm for families of children with ADHD: review and future directions. Chronis, AM., Chacko, A., Fabiano, GA., et al.[2019]

Citations

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In this study, we found that in addition to decreased ADHD symptoms and decreased negative parenting, the BPT group exhibited significantly ...

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Parent Training in Behavior Management for ADHD

When parents become trained in behavior therapy, they learn skills and strategies to help their child with ADHD succeed at school, at home, and ...