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

NCT05796427 | Active Not Recruiting

• 1 other identifier: 2023-5814
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

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.

Conditions

ADHD

Outcome Measures

Primary Outcomes (2)

• Attention-deficit/hyperactivity disorder (ADHD) Treatment Utilization

  Items from the National Survey of the Diagnosis and Treatment of ADHD and Tourette Syndrome (NS-DATA). Centers for Disease Control (CDC) survey used to evaluate treatment use among children with ADHD and Tourette syndrome.

  3 months

• Attention-deficit/hyperactivity disorder (ADHD) Symptoms and Functioning

  Vanderbilt ADHD Diagnostic Rating Scale (VADRS). 55-item, parent-report questionnaire that assesses symptoms of ADHD and comorbidities as well as functional impairment in multiple domains (academics, family and peer relationships).

  3 months

Secondary Outcomes (12)

• Engagement Objectives

  3 months

• Parent ADHD Treatment Preferences

  3 months

• Attention-deficit/hyperactivity disorder (ADHD) Knowledge

  3 months

• Parent Activation

  3 months

• Family Relationships

  3 months

Study Arms (2)

START Intervention

EXPERIMENTAL

Participants in the experimental group will be part of a 6-module weekly intervention where they will learn more about ADHD and its treatment.

Behavioral: SupporT for ADHD and Related Treatment

Educational Brochure

NO INTERVENTION

Participants in the control group will receive an educational brochure by Children and Adults with Attention-Deficit/Hyperactivity Disorder (CHADD).

Interventions

SupporT for ADHD and Related Treatment BEHAVIORAL

Intervention will include 6 modules typically taught over 6-7 weeks. Participants will have up to 3 months to complete the intervention. Modules will provide more knowledge on ADHD, discuss stigma around ADHD, address barriers in receiving care, encourage communication with physician and child, and empower caregivers. Overall, the goal being to improve engagement in ADHD treatment for newly diagnosed or unengaged families. This intervention is mostly targeted towards primary caregivers. However, the last module explicitly includes the child.

START Intervention

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Ann & Robert H. Lurie Children's Hospital

Chicago, Illinois, 60611, United States

Location

Related Publications (10)

• Visser SN, Danielson ML, Bitsko RH, Holbrook JR, Kogan MD, Ghandour RM, Perou R, Blumberg SJ. Trends in the parent-report of health care provider-diagnosed and medicated attention-deficit/hyperactivity disorder: United States, 2003-2011. J Am Acad Child Adolesc Psychiatry. 2014 Jan;53(1):34-46.e2. doi: 10.1016/j.jaac.2013.09.001. Epub 2013 Nov 21.

  PMID: 24342384 BACKGROUND

• Cherkasova MV, Roy A, Molina BSG, Scott G, Weiss G, Barkley RA, Biederman J, Uchida M, Hinshaw SP, Owens EB, Hechtman L. Review: Adult Outcome as Seen Through Controlled Prospective Follow-up Studies of Children With Attention-Deficit/Hyperactivity Disorder Followed Into Adulthood. J Am Acad Child Adolesc Psychiatry. 2022 Mar;61(3):378-391. doi: 10.1016/j.jaac.2021.05.019. Epub 2021 Jun 8.

  PMID: 34116167 BACKGROUND

• Shaw M, Hodgkins P, Caci H, Young S, Kahle J, Woods AG, Arnold LE. A systematic review and analysis of long-term outcomes in attention deficit hyperactivity disorder: effects of treatment and non-treatment. BMC Med. 2012 Sep 4;10:99. doi: 10.1186/1741-7015-10-99.

  PMID: 22947230 BACKGROUND

• Coker TR, Elliott MN, Toomey SL, Schwebel DC, Cuccaro P, Tortolero Emery S, Davies SL, Visser SN, Schuster MA. Racial and Ethnic Disparities in ADHD Diagnosis and Treatment. Pediatrics. 2016 Sep;138(3):e20160407. doi: 10.1542/peds.2016-0407. Epub 2016 Aug 23.

  PMID: 27553219 BACKGROUND

• Shi Y, Hunter Guevara LR, Dykhoff HJ, Sangaralingham LR, Phelan S, Zaccariello MJ, Warner DO. Racial Disparities in Diagnosis of Attention-Deficit/Hyperactivity Disorder in a US National Birth Cohort. JAMA Netw Open. 2021 Mar 1;4(3):e210321. doi: 10.1001/jamanetworkopen.2021.0321.

  PMID: 33646315 BACKGROUND

• Geneva, WHO. Patient Engagement: Technical Series on Safer Primary Care. Published online 2016. Accessed January 7, 2022. https://apps.who.int/iris/bitstream/handle/10665/252269/9789241511629-eng.pdf

  BACKGROUND

• Spencer AE, Sikov J, Loubeau JK, Zolli N, Baul T, Rabin M, Hasan S, Rosen K, Buonocore O, Lejeune J, Dayal R, Fortuna L, Borba C, Silverstein M. Six Stages of Engagement in ADHD Treatment Described by Diverse, Urban Parents. Pediatrics. 2021 Oct;148(4):e2021051261. doi: 10.1542/peds.2021-051261. Epub 2021 Sep 16.

  PMID: 34531290 BACKGROUND

• Paidipati CP, Brawner B, Eiraldi R, Deatrick JA. Parent and Family Processes Related to ADHD Management in Ethnically Diverse Youth. J Am Psychiatr Nurses Assoc. 2017 Mar/Apr;23(2):90-112. doi: 10.1177/1078390316687023. Epub 2017 Jan 11.

  PMID: 28076687 BACKGROUND

• Epstein JN, Kelleher KJ, Baum R, Brinkman WB, Peugh J, Gardner W, Lichtenstein P, Langberg J. Variability in ADHD care in community-based pediatrics. Pediatrics. 2014 Dec;134(6):1136-43. doi: 10.1542/peds.2014-1500. Epub 2014 Nov 3.

  PMID: 25367532 BACKGROUND

• Brinkman WB, Epstein JN. Promoting productive interactions between parents and physicians in the treatment of children with attention-deficit/hyperactivity disorder. Expert Rev Neurother. 2011 Apr;11(4):579-88. doi: 10.1586/ern.10.151.

  PMID: 21469930 BACKGROUND

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Chair for Research in Psychiatry

Study Record Dates

• First Submitted: March 20, 2023
• First Posted: April 3, 2023
• Study Start: July 1, 2023
• Primary Completion: November 1, 2025
• Study Completion: December 31, 2025
• Last Updated: September 12, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)