ACTIVE_NOT_RECRUITING

Testing "SupporT for ADHD and Related Treatment" (START) for Families of Children With ADHD

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Testing a Novel ADHD Engagement Intervention "START" to Improve Access to Treatment

Quick Facts

Study Start:2023-07-01

Study Completion:2025-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05796427

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:6 Years to 12 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Locations (Sites)

Ann & Robert H. Lurie Children's Hospital

Chicago, Illinois, 60611

United States

Collaborators and Investigators

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-07-01

Study Completion Date2025-12-31

Study Record Updates

Study Start Date2023-07-01

Study Completion Date2025-12-31

Terms related to this study

Additional Relevant MeSH Terms

ADHD