Clinical trial NCT05796427: Testing "SupporT for ADHD and Related Treatment" (START) for Families of Children With ADHD
Official title: Testing a Novel ADHD Engagement Intervention "START" to Improve Access to Treatment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: ADHD
Lead sponsor: Ann & Robert H Lurie Children's Hospital of Chicago
Sponsor class: OTHER
First posted: 2023-04-03
Enrollment: 106
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Attention-deficit/hyperactivity disorder (ADHD) Treatment Utilization
timeFrame: 3 months
measure: Attention-deficit/hyperactivity disorder (ADHD) Symptoms and Functioning
timeFrame: 3 months
Secondary outcomes:
measure: Engagement Objectives
timeFrame: 3 months
measure: Parent ADHD Treatment Preferences
timeFrame: 3 months
measure: Attention-deficit/hyperactivity disorder (ADHD) Knowledge
timeFrame: 3 months
measure: Parent Activation
timeFrame: 3 months
measure: Family Relationships
timeFrame: 3 months
measure: Parenting Stress
timeFrame: 3 months
measure: Social Risk
timeFrame: 3 months
measure: Parent Self Stigma
timeFrame: 3 months
measure: Parent Perceived Stigma
timeFrame: 3 months
measure: Child Education
timeFrame: 3 months
measure: ADHD School Services
timeFrame: 3 month
measure: ADHD Stages of Engagement Questionnaire
timeFrame: 3 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Ann & Robert H. Lurie Children's Hospital
state: Illinois
Study officials:
References:
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