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

ADHD Clinical Trial

— START  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05796427
• Other study ID #: 2023-5814
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2023
• Est. completion date: March 2025

Study information

• Verified date: February 2024
• Source: Ann & Robert H Lurie Children's Hospital of Chicago
• Contact: Andrea E Spencer, MD
• Phone: 3122273402
• Email: aspencer[@]luriechildrens.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 106
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• ADHD
• Attention Deficit Disorder with Hyperactivity

Intervention

Behavioral:
• SupporT for ADHD and Related Treatment
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.

Locations

Country	Name	City	State
United States	Ann & Robert H. Lurie Children's Hospital	Chicago	Illinois

Sponsors (1)

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

Country where clinical trial is conducted

United States, 

References & Publications (10)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Engagement Objectives	Attention-deficit/hyperactivity disorder (ADHD) Treatment Engagement Questionnaire. Developed by the PI for the pilot trial to assess engagement objectives directly corresponding to the conceptual model.	3 months
Secondary	Parent ADHD Treatment Preferences	Attention-deficit/hyperactivity disorder (ADHD) Preference and Goal Instrument (PGI). Validated measure used in ADHD engagement studies that assesses parent perceptions of treatment feasibility, acceptability, and adverse effects for medication and therapy separately, as well as overall treatment goals.	3 months
Secondary	Attention-deficit/hyperactivity disorder (ADHD) Knowledge	Attention-deficit/hyperactivity disorder (ADHD) Content Knowledge Questionnaire. 10-item parent quiz developed by the PI for the pilot trial and showing an increase in ADHD knowledge post-intervention.	3 months
Secondary	Parent Activation	Parent-Patient Activation Measure (P-PAM). 13-item, parent-report measure adapted from the well-validated Patient Activation Measure (PAM) with acceptable reliability and validity.	3 months
Secondary	Family Relationships	NIH Patient Reported Outcomes Measurement Information System (PROMIS) Pediatric Family Relationships Short Form. Created for the NIH PROMIS® using mixed methods, estimates the quality of the child's relationship with family in 8 items on a 5-point Likert scale with strong internal consistency and retest-reliability.	3 months
Secondary	Parenting Stress	Parenting Stress Index-Short Form (PSI-SF) Brief, 36-item version of the full 120-item PSI, and one of the most common instruments used to measure parenting stress.	3 months
Secondary	Social Risk	Child Healthwatch Vital Signs (food, housing, utilities)	3 months
Secondary	Parent Self Stigma	Parents' Self Stigma Scale (PSSS); 11-item scale assessing Parents' stigma	3 months
Secondary	Parent Perceived Stigma	Parent Perceived Stigma of Services Seeking Scale (PPSSS); 17-item scale assessing stigma toward seeking services for mental health resources	3 months
Secondary	Child Education	Education Activation; 10-item scale assessing parents' involvement in child's education	3 months
Secondary	ADHD School Services	Attention-deficit/hyperactivity disorder (ADHD) Preference and Goal Instrument (PGI)- School Services. Validated measure used in ADHD engagement studies that assesses school services.	3 month
Secondary	ADHD Stages of Engagement Questionnaire	Survey identifies what stage of engagement the participant is in.	3 months