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Completed

NCT Number: NCT05796427

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

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.

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Key information

Conditions

ADHD Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ann & Robert H. Lurie Children's Hospital

Chicago, Illinois, 60611, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Attention-deficit/hyperactivity disorder (ADHD) Treatment Utilization

    Time frame: 3 months

    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.

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

    Time frame: 3 months

    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).

Secondary outcomes

  1. Engagement Objectives

    Time frame: 3 months

    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.

  2. Parent ADHD Treatment Preferences

    Time frame: 3 months

    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. Attention-deficit/hyperactivity disorder (ADHD) Knowledge

    Time frame: 3 months

    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.

  4. Parent Activation

    Time frame: 3 months

    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.

  5. Family Relationships

    Time frame: 3 months

    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.

  6. Parenting Stress

    Time frame: 3 months

    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.

  7. Social Risk

    Time frame: 3 months

    Child Healthwatch Vital Signs (food, housing, utilities)

  8. Parent Self Stigma

    Time frame: 3 months

    Parents' Self Stigma Scale (PSSS)

    11-item scale assessing Parents' stigma

  9. Parent Perceived Stigma

    Time frame: 3 months

    Parent Perceived Stigma of Services Seeking Scale (PPSSS)

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

  10. Child Education

    Time frame: 3 months

    Education Activation

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

  11. ADHD School Services

    Time frame: 3 month

    Attention-deficit/hyperactivity disorder (ADHD) Preference and Goal Instrument (PGI)- School Services. Validated measure used in ADHD engagement studies that assesses school services.

  12. ADHD Stages of Engagement Questionnaire

    Time frame: 3 months

    Survey identifies what stage of engagement the participant is in.

Sponsors and collaborators

Lead sponsor

Ann & Robert H Lurie Children's Hospital of Chicago

Other

Registry information

Official study title

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

Acronym: START

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Apr 3, 2023
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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