START Program for ADHD

(START Trial)

Overseen By Kryztal Pena, BA

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago

Disqualifiers: Intellectual disability, Psychotic symptoms, others

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

Compensation: Varies

Number of Visits: 7

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a new program called START (SupporT for ADHD and Related Treatment) can help children with ADHD and their families access treatment more effectively and improve daily life. The researchers believe the program will increase family engagement with treatments and enhance relationships at home and school. Participants will either join a 6-session program about ADHD or receive an educational brochure. Children aged 6 to 12 with a new or untreated ADHD diagnosis might be a good fit. As an unphased trial, this study offers families a unique opportunity to access innovative support strategies that could enhance their daily experiences.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, if you have been treated for ADHD in the past 12 months, you are not eligible to participate.

What prior data suggests that the START program is safe for participants?

Research has shown that the START program, designed to assist with ADHD treatment, aims to simplify access to care and enhance daily life for children and their families. Although detailed safety information is limited, the program's non-invasive and educational nature suggests it is likely safe.

The START program consists of six sessions where participants learn about ADHD and its treatment. Due to its educational and supportive focus, it is unlikely to cause the side effects sometimes associated with medication. Similar programs have not reported negative side effects, supporting the safety of this approach.

Additionally, trained non-professionals deliver START, indicating the program's simplicity and safety. This should reassure those considering joining the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the START Program for ADHD because it introduces a structured, interactive learning method through a 6-module weekly intervention. Unlike typical treatments that often rely on medication like stimulants or behavioral therapy, this program focuses on empowering participants with knowledge about ADHD and its treatment. The personalized education approach could enhance self-management skills, potentially leading to better long-term outcomes for individuals with ADHD.

What evidence suggests that the START program is effective for ADHD?

Research shows that programs teaching parents to manage their child's behavior can help children with ADHD function better. In this trial, participants in the START intervention group will engage in a series of organized lessons aimed at improving family and friend relationships and reducing stress for parents. Studies suggest that focusing on education and support can lead to better social skills and school performance for children with ADHD. For example, children in similar programs often become better at paying attention and getting along with others. While specific data on START's effectiveness is still being collected, its methods are based on proven ADHD treatment strategies. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for children aged 6-12 with a new or previously untreated ADHD diagnosis, confirmed by the study's psychiatrist. They must be able to understand and follow the study in English. Children treated for other conditions can join if it wasn't for ADHD.

Inclusion Criteria

They can understand and complete informed consent and study procedures in English

My child has been diagnosed with ADHD by a specialist.

My child has ADHD and hasn't been treated for it in the last year.

Exclusion Criteria

I cannot complete study procedures in English.

My child is either under 6 or over 12 years old.

Children with intellectual disability/cognitive impairment or psychotic symptoms

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants in the experimental group undergo a 6-module weekly intervention called START, while controls receive an educational brochure

6 weeks

6 visits (in-person)

Follow-up

Participants are monitored for treatment engagement, functional improvements, and other outcomes

3 months

What Are the Treatments Tested in This Trial?

Interventions

• SupporT for ADHD and Related Treatment

Trial Overview The START program aims to improve access to ADHD treatment and family functioning. It involves six sessions covering various modules, delivered by trained individuals. The effectiveness will be compared against controls who receive only an informational pamphlet.

How Is the Trial Designed?

Group I: START Intervention Experimental Treatment 1 Intervention

Participants in the experimental group will be part of a 6-module weekly intervention where they will learn more about ADHD and its treatment.

Group II: Educational Brochure Active Control 1 Intervention

Participants in the control group will receive an educational brochure by Children and Adults with Attention-Deficit/Hyperactivity Disorder (CHADD).

Who Is Running the Clinical Trial?

Ann & Robert H Lurie Children's Hospital of Chicago

Lead Sponsor

Trials

275

Recruited

5,182,000+

Published Research Related to This Trial

A multicenter study involving 72 adult ADHD patients demonstrated that a structured skills training program significantly improved ADHD symptoms, depressive symptoms, and personal health status, with a p-value of less than 0.001, indicating strong statistical significance.

The program was well accepted by patients, who found topics like 'behavioral analyses,' 'mindfulness,' and 'emotion regulation' particularly helpful, suggesting that these areas are effective in addressing ADHD symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Structured group psychotherapy in adults with attention deficit hyperactivity disorder: results of an open multicentre study. Philipsen, A., Richter, H., Peters, J., et al.[2022]

The Summer Treatment Program (STP) is an effective intensive intervention for children with ADHD, incorporating strategies like a reward system, time-out, and clear rules to improve behavior.

Parents are actively involved in the program through management training, which helps them apply similar techniques at home, enhancing the overall effectiveness of the treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Summer treatment programs for youth with ADHD. Fabiano, GA., Schatz, NK., Pelham, WE.[2022]

ADHD medications, particularly stimulants, are effective treatments but can lead to various side effects, making it crucial to understand their prevalence and management strategies.

The review highlights the importance of recognizing and managing adverse events associated with ADHD medications to ensure safe and effective treatment for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Managing the risks of ADHD treatments. Schneider, BN., Enenbach, M.[2021]

A study involving 45 adults with ADHD showed that ADHD coaching positively impacted various areas of concern, indicating its potential efficacy as a supportive intervention.

The research found significant test-retest reliability for the factors analyzed, suggesting that the benefits of ADHD coaching are consistent over time, although further studies are needed to fully understand its long-term effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of ADHD coaching for adults with ADHD. Kubik, JA.[2015]

The Collaborative Life Skills (CLS) program provides a comprehensive intervention for children with ADHD, involving training for teachers, parents, and children over 10 to 12 weeks to improve academic and social outcomes.

Booster treatments in subsequent school years are essential for maintaining the benefits of the initial intervention, highlighting the need for ongoing support to prevent long-term negative impacts on education and social relationships.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Promoting Success Across School Years for Children With Attention-Deficit/Hyperactivity Disorder: Collaborative School-Home Intervention. DuPaul, GJ.[2019]

Patients with substance use disorders (SUD) should be screened for ADHD as soon as their drug use stabilizes, due to the high prevalence of ADHD in this population.

Effective treatment for patients with both ADHD and SUD includes a combination of psycho-education, coaching, cognitive behavioral therapy, and pharmacotherapy, with adaptations made to address the unique challenges of managing both conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Summary of the practice guideline for the diagnosis and treatment of ADHD in adolescents and adults with addictions]. Matthys, F., Joostens, P., van den Brink, W., et al.[2015]

In a 12-week study involving 55 adolescents treated with osmotic-release oral system methylphenidate (MPH) for ADHD, both patients and parents reported similar adverse events (AEs), but clinicians identified more AEs, especially at week 6, suggesting the need for comprehensive reporting methods.

The study highlights the importance of using a drug-specific checklist for clinicians to better capture AEs, as differences in reported AEs between patients and parents indicate that gathering information from both sources can provide a fuller picture of the treatment's safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Two different solicitation methods for obtaining information on adverse events associated with methylphenidate in adolescents: a 12-week multicenter, open-label study. Lee, MS., Lee, SI., Hong, SD., et al.[2015]

Non-pharmacological treatments for ADHD, such as parental training and behavior modification, resulted in significantly higher treatment compliance (95.56%) compared to pharmacological treatments (71.11%), suggesting they may be more acceptable to patients.

While both treatment approaches did not show significant differences in overall ADHD symptom scores, non-pharmacological interventions led to better outcomes in family relationships and daily life skills, indicating they can enhance social functioning and self-concept without the adverse effects associated with long-term medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of non-pharmacological treatment on the full recovery of social functioning in patients with attention deficit hyperactivity disorder. Lv, YB., Cheng, W., Wang, MH., et al.[2023]

The automated trigger algorithm successfully identified potential adverse events in 8% of parent-reported ADHD assessments, leading to timely clinician reviews and changes in care plans for 46% of actionable alerts.

Patients with triggered alerts showed significantly worsened ADHD severity scores prior to the alerts, indicating that the algorithm effectively highlighted those needing immediate attention and intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Timely Interventions for Children with ADHD through Web-Based Monitoring Algorithms. Oppenheimer, J., Ojo, O., Antonetty, A., et al.[2020]

A review of 43 studies involving around 7000 children found that common adverse drug reactions (ADRs) from ADHD medications included decreased appetite, gastrointestinal pain, and headaches, primarily reported by children or their parents.

Most studies reported low rates of serious ADRs, but many children dropped out due to serious reactions, suggesting that the actual incidence of serious ADRs may be higher, highlighting the need for long-term safety studies on ADHD medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The occurrence of adverse drug reactions reported for attention deficit hyperactivity disorder (ADHD) medications in the pediatric population: a qualitative review of empirical studies. Aagaard, L., Hansen, EH.[2021]

A systematic review of 35 studies on ADHD treatments showed that all recommended interventions led to significant improvements in core symptoms, with reductions in symptoms ranging from 20% to 86%.

The studies, primarily using DSM-criteria-based rating scales, demonstrated a consistent pattern of improvement across various treatment types, suggesting that measuring symptom reduction within one year could serve as an effective outcome measure for ADHD care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Considerations and evidence for an ADHD outcome measure. Woods, D., Wolraich, M., Pierce, K., et al.[2019]

In a study of 1429 ADHD patients across 16 centers, those receiving combined treatment (medication and psychological therapy) showed a significantly higher improvement rate (65.5%) compared to those on methylphenidate alone (54.4%), psychological treatment alone (53.4%), or no therapy (40.5%).

There was considerable variation in treatment outcomes between centers, with the expected probability of improvement ranging from 47.7% to 61.2%, suggesting that center-specific approaches and attitudes significantly influence patient recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Differences between centers in functional outcome of patients with ADHD after 1 year from the time of diagnosis. Cartabia, M., Finazzi, S., Bonati, M.[2023]

The group parenting intervention program for children at risk of ADHD did not show significant improvement in core ADHD symptoms, as measured by the ADHD index, after 6 months.

However, the combined intervention showed a potential reduction in parent-reported hyperactivity symptoms and the parent-only intervention improved parental mental health, suggesting some secondary benefits from the program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness and cost-effectiveness of a brief school-based group programme for parents of children at risk of ADHD: a cluster randomised controlled trial. Sayal, K., Taylor, JA., Valentine, A., et al.[2017]

ADHD is a common and treatable condition, but current clinical trials often exclude patients with comorbidities or non-compliance, which limits our understanding of treatment effectiveness in real-world settings.

To improve ADHD treatment outcomes, it is essential to conduct effectiveness studies that consider factors like patient compliance, comorbid conditions, and individual preferences, as these greatly influence treatment success and persistence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness outcomes in attention-deficit/hyperactivity disorder. Weiss, MD., Gadow, K., Wasdell, MB.[2015]

ADHD is likely not just one condition but a group of related disorders, often occurring alongside mood, anxiety, and conduct disorders, which suggests varying causes and effects.

Children with ADHD who also have comorbid disorders tend to experience worse outcomes, facing more significant social, emotional, and psychological challenges, highlighting the need for targeted research to understand these complexities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ADHD and comorbidity in childhood. Spencer, TJ.[2006]

Citations

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Study Details | Testing "SupporT for ADHD and Related ... Data collected at the beginning of a clinical study for all participants and for each arm or comparison group. These data include demographics, such as age, sex ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11162428/

Improving the efficacy and effectiveness of evidence-based ... Overall, commercialized BPT and homegrown BPT have been found to be effective in improving the functioning of children with ADHD and their ...

3. ctv.veeva.com ctv.veeva.com/study/testing-support-for-adhd-and-related-treatment-start-for-families-of-children-with-adhd

Testing "SupporT for ADHD and Related Treatment" (START ... Investigators believe the intervention group will show better functioning including improved family and peer relationships and reduced parent stress compared to ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4644615/

Treatment Programs for Students With Attention Deficit ... The aim of this study was to determine the experimental evidence of treatment/intervention programs for deficits in social skills, attention, and behavioral ...

5. publications.aap.org publications.aap.org/pediatrics/article/144/4/e20192528/81590/Clinical-Practice-Guideline-for-the-Diagnosis

Clinical Practice Guideline for the Diagnosis, Evaluation ... Clinical practice guideline for the diagnosis, evaluation, and treatment of attention-deficit/hyperactivity disorder in children and adolescents.

6. grants.nih.gov grants.nih.gov/grants/guide/rfa-files/RFA-MH-26-195.html

RFA-MH-26-195: Optimizing Treatment Strategies for Adult ... A clinical trial aimed at personalizing treatment of adults with ADHD plus substance use disorders or other specific comorbidities. Potential ...

7. fda.gov fda.gov/media/130268/download

NDA 022063 WRITTEN REQUEST Shire Development, LLC. ... Attention deficit hyperactivity disorder (ADHD) is a common neurobehavioral disorder in children and adolescents. It is characterized by a pattern of ...

8. pcori.org pcori.org/research-results/2021/attention-deficit-hyperactivity-disorder-diagnosis-and-treatment-children-and-adolescents-systematic-review

Attention Deficit Hyperactivity Disorder: Diagnosis and ... A systematic evidence review on diagnosis and treatment for attention deficit hyperactivity disorder (ADHD) in children and adolescents.