Support program for families of children with ADHD
Testing a Novel ADHD Engagement Intervention "START" to Improve Access to Treatment
NA · Ann & Robert H Lurie Children's Hospital of Chicago · NCT05796427
This study is trying out a support program for families of children with ADHD to see if it helps them get better treatment and improves their daily lives.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 106 (estimated) |
| Ages | 6 Years to 12 Years |
| Sex | All |
| Sponsor | Ann & Robert H Lurie Children's Hospital of Chicago (other) |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT05796427 on ClinicalTrials.gov |
What this trial studies
This randomized control trial aims to evaluate the effectiveness of the SupporT for ADHD and Related Treatment (START) program in increasing access to ADHD treatment and improving functional outcomes for children and their families. Participants will undergo a psychiatric evaluation before being randomized into the intervention group, which will receive the START program, or a control group that will receive informational pamphlets. The START program consists of six modules delivered over six sessions by trained staff, focusing on enhancing treatment engagement and reducing parent stress while improving family and peer relationships. The study will assess both treatment access and functional improvements in home, social, and academic domains.
Who should consider this trial
Good fit: Ideal candidates are children aged 6 to 12 years with a recent or untreated diagnosis of ADHD.
Not a fit: Patients who have been actively treated for ADHD or those outside the specified age range may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly enhance treatment engagement and improve the quality of life for children with ADHD and their families.
How similar studies have performed: Other studies have shown positive outcomes with similar interventions aimed at improving ADHD treatment access and family support.
Eligibility criteria
Show full inclusion / exclusion criteria
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 school age children and may require a different approach for engaging them and their parents in ADHD care. Children under 6 with ADHD symptoms may not yet be diagnosed and may not have the same treatment access or options as children 6 and over. Adolescents over 12 are more independent and an intervention may need to be more focused on the adolescent than our current intervention which is primarily parent focused. * Children who were diagnosed over 3 months ago and already received treatment for ADHD will be excluded since our primary outcome is treatment engagement. * Because this is an intervention only available in English at this time, participants who are not able to complete study procedures in English will be excluded.
Where this trial is running
Chicago, Illinois
- Ann & Robert H. Lurie Children's Hospital — Chicago, Illinois, United States (RECRUITING)
Study contacts
- Study coordinator: Andrea E Spencer, MD
- Email: aspencer@luriechildrens.org
- Phone: 3122273402
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: ADHD