Testing "SupporT for ADHD and Related Treatment" (START) for Families of Children With ADHD (NCT05796427) | Clinical Trial Compass
CompletedNot Applicable
Testing "SupporT for ADHD and Related Treatment" (START) for Families of Children With ADHD
United States100 participantsStarted 2023-07-01
Plain-language summary
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.
Who can participate
Age range
6 Years – 12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* The child is greater than or equal to 6 years old and less than or equal to 12 years old
* The child has a diagnosis of ADHD confirmed based on clinical psychiatric evaluation with an expert child psychiatrist on the study team (PI or Co-I)
* The diagnosis of ADHD is either new (defined as made for the first time by the study psychiatrist OR made for the first time within the prior 3 months by a medical or mental health provider) OR the child has been previously diagnosed but untreated either since diagnosis or for at least the prior 12 months. "Untreated" is defined as having received no therapeutic, medication, or school accommodations specifically for ADHD.
* They can understand and complete informed consent and study procedures in English.
* Children who have received treatment for other psychiatric conditions may be included if the treatment was specifically for a condition other than ADHD, to be confirmed by the study psychiatrist at enrollment.
Exclusion Criteria:
* Children with most comorbid (i.e., co-existing) psychiatric conditions with be included, but children with intellectual disability/cognitive impairment or psychotic symptoms will be excluded because these conditions would substantially change the focus of treatment
* Children under 6 and over 12 will be excluded because the intervention was specifically designed for school age children in this age group. Developmental, adolescents and preschoolers are considerably different than sch…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial, called START, focused on supporting families of children with ADHD in accessing and using treatment — since it's already completed, has my doctor seen any of the findings, and do the results suggest this kind of support program helped kids actually get better care?
2Since this was listed as Phase NA, which often means it's testing a support or behavioral program rather than a drug, would something like the START program be something my child's care team could offer, or is it only available through the research study?
3The trial measured both ADHD symptoms and how well children were functioning day-to-day — based on what's known about this study, were families who went through the START program able to see real improvements in those areas compared to families who didn't?
4Because the trial is now completed, should we be looking for published results, and how would my doctor recommend I find and understand those findings so I can decide if this type of family support program makes sense for us?
5Before exploring programs like START, are there standard, already-available treatments or parent training programs my doctor would recommend we try first, and how does a support-focused program like this fit alongside things like medication or behavioral therapy?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.