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ADHDSTARTNCT05796427

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

A study testing SupporT for ADHD and Related Treatment in people with ADHD, run by Ann & Robert H Lurie Children's Hospital of Chicago at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 6 to 12 years
Conditions the study is for
ADHD
What is being tested?
SupporT for ADHD and Related Treatment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteUnited States
Study dates
1 Jul 2023to 28 Nov 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 12 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Ann & Robert H. Lurie Children's Hospital

    Chicago, Illinois, 60611

Other trials in United States

About this study

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

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
Being tested
SupporT for ADHD and Related Treatment
Medical subject headings
Attention Deficit Disorder with Hyperactivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SupporT for ADHD and Related TreatmentBehavioural

    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.

Study groups in NCT05796427
Study groupRoleWhat they receive
START InterventionExperimentalParticipants in the experimental group will be part of a 6-module weekly intervention where they will learn more about ADHD and its treatment.
Receives: Behavioral: SupporT for ADHD and Related Treatment
Educational BrochureNo interventionParticipants in the control group will receive an educational brochure by Children and Adults with Attention-Deficit/Hyperactivity Disorder (CHADD).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 3 months

  2. 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).

    Measured: 3 months

Secondary outcomes (12)
  1. 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.

    Measured: 3 months

  2. 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.

    Measured: 3 months

  3. 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.

    Measured: 3 months

  4. 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.

    Measured: 3 months

  5. 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.

    Measured: 3 months

  6. 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.

    Measured: 3 months

  7. Social Risk

    Child Healthwatch Vital Signs (food, housing, utilities)

    Measured: 3 months

  8. Parent Self Stigma

    Parents' Self Stigma Scale (PSSS)

    11-item scale assessing Parents' stigma

    Measured: 3 months

  9. Parent Perceived Stigma

    Parent Perceived Stigma of Services Seeking Scale (PPSSS)

    17-item scale assessing stigma toward seeking services for mental health resources

    Measured: 3 months

  10. Child Education

    Education Activation

    10-item scale assessing parents' involvement in child's education

    Measured: 3 months

  11. 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.

    Measured: 3 month

  12. ADHD Stages of Engagement Questionnaire

    Survey identifies what stage of engagement the participant is in.

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Apr 2023
  2. Study start1 Jul 2023
  3. Primary completion28 Nov 2025
  4. Study completion28 Nov 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05796427
Sponsor's protocol ID
2023-5814
Acronym
START
Status last verified
Jun 2025
First submitted
20 Mar 2023
Last updated
10 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 24342384
  • 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.

    PubMed 34116167
  • 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.

    PubMed 22947230
  • 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.

    PubMed 27553219
  • 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.

    PubMed 33646315
  • 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

  • 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.

    PubMed 34531290
  • 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.

    PubMed 28076687
  • 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.

    PubMed 25367532
  • 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.

    PubMed 21469930

Questions about this trial

What is this clinical trial studying?

A study testing SupporT for ADHD and Related Treatment in people with ADHD, run by Ann & Robert H Lurie Children's Hospital of Chicago at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Attention-deficit/hyperactivity disorder (ADHD) Treatment Utilization (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05796427, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.

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