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

Primary Purpose

ADHD

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
SupporT for ADHD and Related Treatment
Sponsored by
Ann & Robert H Lurie Children's Hospital of Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for ADHD

Eligibility Criteria

6 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    START Intervention

    Educational Brochure

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    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.
    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).

    Secondary Outcome Measures

    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.
    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.
    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.
    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.
    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.
    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.
    Social Risk
    Child Healthwatch Vital Signs (food, housing, utilities)
    Parent Self Stigma
    Parents' Self Stigma Scale (PSSS) 11-item scale assessing Parents' stigma
    Parent Perceived Stigma
    Parent Perceived Stigma of Services Seeking Scale (PPSSS) 17-item scale assessing stigma toward seeking services for mental health resources
    Child Education
    Education Activation 10-item scale assessing parents' involvement in child's education

    Full Information

    First Posted
    March 20, 2023
    Last Updated
    May 24, 2023
    Sponsor
    Ann & Robert H Lurie Children's Hospital of Chicago
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05796427
    Brief Title
    Testing "SupporT for ADHD and Related Treatment" (START) for Families of Children With ADHD
    Acronym
    START
    Official Title
    Testing a Novel ADHD Engagement Intervention "START" to Improve Access to Treatment
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 2023 (Anticipated)
    Primary Completion Date
    March 2025 (Anticipated)
    Study Completion Date
    March 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Ann & Robert H Lurie Children's Hospital of Chicago

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    ADHD

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    106 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    START Intervention
    Arm Type
    Experimental
    Arm Description
    Participants in the experimental group will be part of a 6-module weekly intervention where they will learn more about ADHD and its treatment.
    Arm Title
    Educational Brochure
    Arm Type
    No Intervention
    Arm Description
    Participants in the control group will receive an educational brochure by Children and Adults with Attention-Deficit/Hyperactivity Disorder (CHADD).
    Intervention Type
    Behavioral
    Intervention Name(s)
    SupporT for ADHD and Related Treatment
    Intervention Description
    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 Outcome Measure Information:
    Title
    Attention-deficit/hyperactivity disorder (ADHD) Treatment Utilization
    Description
    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.
    Time Frame
    3 months
    Title
    Attention-deficit/hyperactivity disorder (ADHD) Symptoms and Functioning
    Description
    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).
    Time Frame
    3 months
    Secondary Outcome Measure Information:
    Title
    Engagement Objectives
    Description
    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.
    Time Frame
    3 months
    Title
    Parent ADHD Treatment Preferences
    Description
    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.
    Time Frame
    3 months
    Title
    Attention-deficit/hyperactivity disorder (ADHD) Knowledge
    Description
    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.
    Time Frame
    3 months
    Title
    Parent Activation
    Description
    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.
    Time Frame
    3 months
    Title
    Family Relationships
    Description
    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.
    Time Frame
    3 months
    Title
    Parenting Stress
    Description
    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.
    Time Frame
    3 months
    Title
    Social Risk
    Description
    Child Healthwatch Vital Signs (food, housing, utilities)
    Time Frame
    3 months
    Title
    Parent Self Stigma
    Description
    Parents' Self Stigma Scale (PSSS) 11-item scale assessing Parents' stigma
    Time Frame
    3 months
    Title
    Parent Perceived Stigma
    Description
    Parent Perceived Stigma of Services Seeking Scale (PPSSS) 17-item scale assessing stigma toward seeking services for mental health resources
    Time Frame
    3 months
    Title
    Child Education
    Description
    Education Activation 10-item scale assessing parents' involvement in child's education
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Years
    Maximum Age & Unit of Time
    12 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Andrea E Spencer, MD
    Phone
    3122273402
    Email
    aspencer@luriechildrens.org
    First Name & Middle Initial & Last Name or Official Title & Degree
    Kryztal Pena, BA
    Phone
    3122271599
    Ext
    71599
    Email
    kpena@luriechildrens.org

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    24342384
    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.
    Results Reference
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    PubMed Identifier
    34116167
    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.
    Results Reference
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    PubMed Identifier
    22947230
    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.
    Results Reference
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    PubMed Identifier
    27553219
    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.
    Results Reference
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    PubMed Identifier
    33646315
    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.
    Results Reference
    background
    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
    Results Reference
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    PubMed Identifier
    34531290
    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.
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    PubMed Identifier
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    Citation
    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.
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    Testing "SupporT for ADHD and Related Treatment" (START) for Families of Children With ADHD

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