START Program for ADHD
(START Trial)
Recruiting in Palo Alto (17 mi)
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago
No Placebo Group
Trial Summary
What is the purpose of this trial?The randomized control trial (RCT) study includes 2 aims; one being to test whether START increases access to treatment for ADHD. Investigators believe the intervention group will demonstrate improved treatment engagement and access to all treatments compared to controls. The second aim is to explore whether START leads to functional improvements across home, social and academic domains for the child and family. Investigators believe the intervention group will show better functioning including improved family and peer relationships and reduced parent stress compared to controls.
Before taking part in our study all participants will undergo a psychiatric evaluation. Eligible participants will be randomized to START while controls receive a pamphlet with ADHD information. Students and staff with related experience who are not mental health professionals will be trained to deliver START. START includes 6 modules, typically delivered over 6 sessions.
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 data supports the idea that START Program for ADHD is an effective treatment?
The available research shows that patients who received combined treatment, which may include programs like the START Program for ADHD, were significantly more likely to improve compared to those who received only medication or psychological treatment alone. Specifically, 65.5% of patients improved with combined treatment, compared to 54.4% with medication alone and 53.4% with psychological treatment alone. This suggests that the START Program, as part of a combined approach, can be an effective treatment for ADHD.
12345What safety data is available for the START Program for ADHD treatment?
The provided research does not directly mention the START Program for ADHD or its safety data. However, it discusses the safety and adverse events associated with ADHD medications in general. The studies highlight the prevalence of adverse events, management strategies, and monitoring methods for ADHD treatments, including stimulants like methylphenidate. These findings suggest that while ADHD medications are effective, they can have side effects such as nausea, dizziness, and sleep disturbances, and require careful monitoring and management.
678910Is the START treatment for ADHD promising?
Yes, the START treatment for ADHD is promising because it includes effective strategies like psycho-education, coaching, and cognitive behavioral therapy, which have been shown to help people with ADHD improve their symptoms and overall well-being.
1112131415Eligibility Criteria
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.
+2 more
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
+1 more
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: START InterventionExperimental Treatment1 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 BrochureActive Control1 Intervention
Participants in the control group will receive an educational brochure by Children and Adults with Attention-Deficit/Hyperactivity Disorder (CHADD).
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Ann & Robert H. Lurie Children's HospitalChicago, IL
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Who Is Running the Clinical Trial?
Ann & Robert H Lurie Children's Hospital of ChicagoLead Sponsor
References
Considerations and evidence for an ADHD outcome measure. [2019]The 2011 American Academy of Pediatrics attention-deficit/hyperactivity disorder (ADHD) guideline emphasizes monitoring and measuring outcomes of children diagnosed with ADHD; however, recommendations for how to measure improvement are less clear. A long-term goal was to develop an outcome measure that assesses the quality of care for children with ADHD. As a first step in that process, we conducted a literature synthesis on the efficacy and effectiveness of guideline-recommended ADHD treatments on patient outcomes.
Differences between centers in functional outcome of patients with ADHD after 1 year from the time of diagnosis. [2023]Although the pharmacological therapy of ADHD has been widely studied, little has been done to compare the different therapeutic approaches (e.g., drug therapy vs. psychological treatments) and even less has been done to compare the outcome of the therapy between centers. This multicenter observational study aims to assess between-center variation in functional outcome of ADHD patients one year after the diagnosis, according to the treatment received. We used the Regional ADHD Registry data on 1429 patients enrolled in 16 ADHD centers in the 2011-2022 period. To evaluate the effectiveness of the therapy we used a generalized linear mixed model with the center as the random effect, including patient condition at diagnosis and center characteristics, weighting by the inverse of the propensity score of the treatment received by the patient. Between-center variation was expressed as the relative difference in odds-ratios between the observed and the expected number of patients whose condition improved, using the Clinical Global Impressions-Improvement Scale (CGI-I), and the relative 95% CI. Patients who received combined treatment were significantly more likely to improve compared to other treatment groups (65.5% vs 54.4% for methylphenidate alone, 53.4% for psychological treatment alone, or 40.5% for no therapy). Adjusted for patients and center characteristics, the log-odds ratio ranged from 0.85 (0.29-1.55 95% CI) to - 0.64 (- 1.17-- 0.18 95% CI). The mean expected probability of improvement after one year of therapy for an average patient with ADHD for each center was 47.7% in a center at the 25th percentile and 61.2% in a center at the 75th percentile of the outcome distribution after adjustments. The wide between-center variation in patient functional improvement one year after the diagnosis of ADHD could be largely explained by center-specific therapeutic approaches or attitudes. More careful and stringent work is needed to reduce differences in responses between centers, as could formal and periodic audit programs within and between centers.
Effectiveness and cost-effectiveness of a brief school-based group programme for parents of children at risk of ADHD: a cluster randomised controlled trial. [2017]National Institute for Health and Care Excellence guidelines recommend a stepped care approach for the identification and management of children with, or at risk of, attention-deficit/hyperactivity disorder (ADHD). We investigated the effectiveness, cost-effectiveness and acceptability of a group parenting intervention programme (+/- a teacher session) for children at risk of ADHD.
Effectiveness outcomes in attention-deficit/hyperactivity disorder. [2015]Attention-deficit/hyperactivity disorder (ADHD) is common, chronic, and associated with significant functional impairment. It is highly treatable. It is therefore not only a major public health problem but also one that provides a unique opportunity in medicine to make a significant difference. This article will discuss the methodology needed to demonstrate empirically the impact of treatment on actual burden of illness in practice. Where efficacy studies demonstrate whether a treatment can work, effectiveness studies tell us whether they actually do work. Clinical trials exclude incompetent, non-compliant, and seriously comorbid patients, so that the information obtained from these trials tells us the most about the patients we see the least. Small differences in effect size in pivotal trials of efficacy have become a key variable for rating treatments as first line or second line, without consideration of effectiveness variables such as comorbidity, difficulty with appetite or sleep, patient preference, capacity for compliance, timing of functional impairment, and substance use. These effectiveness variables are less well studied, but critical to clinical decision making. In reality, fewer than 10% of our patients comply with and persist with treatment. To learn more about why patients are discontinuing treatment, we need to explore measures of effectiveness empirically. Effectiveness studies are also important to provide regulatory bodies with the data they need to balance the risk of treatment with the risk of failing to treat. Practical clinical trials and naturalistic follow-up studies will allow us to evaluate the true clinical impact of short-term efficacy trials.
ADHD and comorbidity in childhood. [2006]In recent years, evidence has been accumulating regarding high levels of comorbidity between attention-deficit/hyperactivity disorder (ADHD) and a number of disorders, including mood and anxiety disorders and conduct disorder. Thus, ADHD is most likely a group of conditions, rather than a single homogeneous clinical entity, with potentially different etiologic and modifying risk factors and different outcomes. Follow-up studies of children with ADHD indicate that subgroups of subjects with ADHD and comorbid disorders have a poorer outcome as evidenced by significantly greater social, emotional, and psychological difficulties. Investigation of these issues should help to clarify the etiology, course, and outcome of ADHD.
Managing the risks of ADHD treatments. [2021]Pharmacotherapy of attention deficit-hyperactivity disorder (ADHD) is a well-established and effective treatment modality. However, ADHD medications are not without side effects. Understanding the prevalence of adverse events and effective management of risks associated with stimulants and other medications used to treat ADHD is central to broad applicability and effective treatment. This review discusses the literature on the prevalence of adverse events and management strategies employed. We searched online MEDLINE/PubMed and Cochrane databases for articles using several keywords relating to adverse events associated with ADHD medication management. We discuss the relevant data on the significance and prevalence of side effects and adverse events, highlight recent updates in the field, and suggest approaches to clinical management.
The occurrence of adverse drug reactions reported for attention deficit hyperactivity disorder (ADHD) medications in the pediatric population: a qualitative review of empirical studies. [2021]To review empirical studies of adverse drug reactions (ADRs) reported to be associated with the use of medications generally licensed for treatment of attention deficit hyperactivity disorder (ADHD) symptoms in the pediatric population.
Two different solicitation methods for obtaining information on adverse events associated with methylphenidate in adolescents: a 12-week multicenter, open-label study. [2015]We explored two different methods of determining adverse events (AEs) among methylphenidate (MPH)-treated adolescents with attention-deficit/hyperactivity disorder (ADHD).
Effect of non-pharmacological treatment on the full recovery of social functioning in patients with attention deficit hyperactivity disorder. [2023]Long-term treatment of attention deficit/hyperactivity disorder (ADHD) is associated with adverse events, such as nausea and vomiting, dizziness, and sleep disturbances, and poor maintenance of late ADHD medication compromises treatment outcomes and prolongs the recovery of patients' social functioning.
Timely Interventions for Children with ADHD through Web-Based Monitoring Algorithms. [2020]The aim of this study was to evaluate an automated trigger algorithm designed to detect potentially adverse events in children with Attention-Deficit/Hyperactivity Disorder (ADHD), who were monitored remotely between visits. We embedded a trigger algorithm derived from parent-reported ADHD rating scales within an electronic patient monitoring system. We categorized clinicians' alert resolution outcomes and compared Vanderbilt ADHD rating scale scores between patients who did or did not have triggered alerts. A total of 146 out of 1738 parent reports (8%) triggered alerts for 98 patients. One hundred and eleven alerts (76%) required immediate clinician review. Nurses successfully contacted parents for 68 (61%) of actionable alerts; 46% (31/68) led to a change in care plan prior to the next scheduled appointment. Compared to patients without alerts, patients with alerts demonstrated worsened ADHD severity (β = 5.8, 95% CI: 3.5⁻8.1 [p < 0.001] within 90 days prior to an alert. The trigger algorithm facilitated timely changes in the care plan in between face-to-face visits.
[Summary of the practice guideline for the diagnosis and treatment of ADHD in adolescents and adults with addictions]. [2015]Various guidelines are available for the diagnosis and treatment of ADHD in adults, but not for patients with ADHD and a comorbid substance use disorder (SUD). In 2010, the Addiction Medicine Working Party, a division of the VAD (Verenigingvoor Alcohol- en andere Drugproblemen/Association for Alcohol and other Drug Problems) developed a practice guideline on how, when and by whom ADHD can be diagnosed in patients with an addiction, and how these patients should be treated. Given the high prevalence of ADHD in treatment-seeking SUD patients and the availability of valid screening instruments, all SUD patients should be screened for ADHD as soon as their drug use has stabilized. Acquiring information from external sources as well as clinical observation and questionnaires are important tools for the establishment of the diagnosis of ADHD. Integrated treatment primarily includes psycho-education, coaching and cognitive behavioural therapy in addition to pharmacotherapy. Evidence-based treatments for addiction may also be effective in patients with concomitant ADHD, provided the methods are adapted to the limitations that are associated with this condition.
Summer treatment programs for youth with ADHD. [2022]Children with attention-deficit/hyperactivity disorder (ADHD) require intensive treatments to remediate functional impairments and promote the development of adaptive skills. The summer treatment program (STP) is an exemplar of intensive treatment of ADHD. STP intervention components include a reward and response-cost point system, time-out, use of antecedent control (clear commands, establishment of rules and routines), and liberal praise and rewards for appropriate behavior. Parents also participate in parent management training programming to learn how to implement similar procedures within the home setting. There is strong evidence supporting the efficacy of the STP as an intervention for ADHD.
Efficacy of ADHD coaching for adults with ADHD. [2015]This is perhaps the first outcome study on the efficacy of ADHD coaching for adults with ADHD and its long-term effect.
Structured group psychotherapy in adults with attention deficit hyperactivity disorder: results of an open multicentre study. [2022]Attention deficit hyperactivity disorder (ADHD) is a serious mental disorder that often persists in adulthood. In a pilot study, a structured skills training group program for adult ADHD led to significant symptomatic improvements. The present study evaluated the program's effectiveness, feasibility, and patient acceptability in a multicenter setting. Seventy-two adult ADHD patients were assigned to 13 two-hour weekly sessions at 4 different therapy sites. The therapy was well tolerated and led to significant improvements of ADHD, depressive symptoms, and personal health status (p
Promoting Success Across School Years for Children With Attention-Deficit/Hyperactivity Disorder: Collaborative School-Home Intervention. [2019]Children with attention-deficit/hyperactivity disorder (ADHD) typically experience significant difficulties in school, including academic underachievement and impairment in social relationships, such that they are at higher than average risk for special education placement, grade retention, school dropout, and lower lifetime educational attainment.1 The chronicity of ADHD symptoms and associated impairments requires proactive maintenance of treatment components across school years if amelioration of deleterious long-term outcomes is to be realized. Pfiffner et al.2 directly address the ongoing school impairments experienced by students with ADHD by following intensive intervention in 1 school year with booster treatment in a subsequent school year. The Collaborative Life Skills (CLS) program includes multiple components initially delivered over 10 to 12 weeks to train teachers in use of classroom accommodations and strategies (e.g., daily report card), parents in use of behavioral strategies at home and ways to collaborate with teachers, and children in social skills and independent task completion.