ADHD Medication + Parent Training for ADHD Families

(TPAC Trial)

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

240 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will compare the effectiveness of combined parental stimulant medication and behavioral parent training (BPT) versus BPT alone on child ADHD-related impairment (primary outcome), child ADHD and externalizing symptoms, time to child stimulant prescription (secondary child outcomes) and parental ADHD impairment, parental ADHD symptoms, parenting, and BPT engagement (parental outcomes/target mechanisms). This study will also assess the care delivery context and develop an implementation approach for treatment of families with a parent with ADHD and a child with elevated ADHD symptoms via telehealth in primary care sites providing pediatric care.

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.

What data supports the effectiveness of the treatment Behavioral Parent Training (BPT) for ADHD families?

Research shows that Behavioral Parent Training (BPT) is effective in improving ADHD symptoms like inattention, hyperactivity, and impulsivity in children. It also helps reduce negative parenting practices and improve overall outcomes for families dealing with ADHD. ^{1 2 3 4 5}

Is Behavioral Parent Training (BPT) safe for families with children who have ADHD?

Behavioral Parent Training (BPT) is considered safe and is an evidence-based treatment for children with ADHD, showing improvements in child behavior and reducing parental stress without reported safety concerns. ^{1 2 3 5 6}

How is the ADHD Medication + Parent Training treatment different from other ADHD treatments?

This treatment is unique because it combines behavioral parent training (BPT) with extended-release mixed amphetamine salts (MAS), addressing both the child's and the parent's ADHD symptoms. This dual approach is particularly beneficial for families where both the parent and child have ADHD, as it improves parenting practices and child outcomes more effectively than medication or behavioral training alone. ^{1 3 4 7 8}

Research Team

Andrea Chronis-Tuscano, Ph.D.

Principal Investigator

University of Maryland, College Park

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Which Techniques Work in Behavioral Parent Training for Children with ADHD? A Randomized Controlled Microtrial. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Enhancements to the behavioral parent training paradigm for families of children with ADHD: review and future directions. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Does a Behavioral Parent Training Program for Parents of ADHD Children Improve Outcomes? A Pilot Project. [2021]

4. United States 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. [2023]

5. Australia 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. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Behavioral Parent Training for ADHD Reduces Situational Severity of Child Noncompliance and Related Parental Stress. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Children with ADHD treated with long-term methylphenidate and multimodal psychosocial treatment: impact on parental practices. [2013]

8. United States pubmed.ncbi.nlm.nih.gov

Acute Effects of Parent Stimulant Medication Versus Behavioral Parent Training on Mothers' ADHD, Parenting Behavior, and At-Risk Children. [2021]