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

Study Overview
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Brief Summary
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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
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Testing a Novel ADHD Engagement Intervention START to Improve Access to Treatment

Conditions
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ADHD

Intervention / Treatment
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* Behavioral: SupporT for ADHD and Related Treatment


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: START Intervention<br>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<br>* 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.<br>|
| No Intervention: Educational Brochure<br>Participants in the control group will receive an educational brochure by Children and Adults with Attention-Deficit/Hyperactivity Disorder (CHADD). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Social Risk | Child Healthwatch Vital Signs (food, housing, utilities) | 3 months | 
| Parent Self Stigma | Parents' Self Stigma Scale (PSSS) 11-item scale assessing Parents' stigma | 3 months | 
| 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 | 
| Child Education | Education Activation 10-item scale assessing parents' involvement in child's education | 3 months |