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Completed

NCT Number: NCT01487967

Preference and Goal Directed Attention Deficit Hyperactivity Disorder Care- Pilot Study

This pilot intervention study will test the feasibility and acceptability and explore the outcomes of an urban, primary care-based intervention to measure families' preferences and goals for Attention-Deficit/Hyperactivity Disorder (ADHD) treatment and structure clinical care to reach these goals.

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Key information

Conditions

Attention Deficit Hyperactivity Disorder 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

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

About this study

The intervention includes provision of enhanced, culturally appropriate education about ADHD and its treatment, completion of a validated preference and goal instrument, use of this instrument in the ADHD treatment decision-making process, and tracking of preferences and goals over time.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • All interested non-trainee clinicians at study sites
  • Parents/legal guardians of children age 6-12, in K-6 grade, diagnosed with ADHD.

Exclusion criteria

  • child diagnosed with autism or a psychotic disorder
  • parents non-English speaking
  • parents unable to provide consent
  • pediatric residents

Treatment and study plan

Preference and Goal Instrument

Other

Families in the intervention arm will receive culturally appropriate educational material, complete the Preference and Goal Instrument at the study start, use the results to inform decision making about ADHD treatment, have their preferences/goals tracked in the electronic health record, and have their progress toward their goals assessed at 3 months and 6 months (approximately).

Primary outcomes

  1. Feasibility of family recruitment and follow-up

    Time frame: Up to 24 months

    The feasibility of this intervention will be assessed by examining the proportion of families screened that meet enrollment criteria, the proportion meeting enrollment criteria that enroll, and the proportion enrolled that complete each study measure.

Secondary outcomes

  1. Joint Participation in Decision-Making and Partnership

    Time frame: Baseline

    Participation in decision-making, measured by the Observing Patient Involvement (OPTION) scale.

    Patient partnership, measured by the Patient Participation in Care Scale score after the initial visit at which ADHD treatment decisions are made

  2. Treatment Acceptability

    Time frame: Baseline, after 3 months, after 6 months

    Treatment acceptability measured by the Treatment Acceptability Questionnaire, Parent version (TAQ-P).

  3. Parent Engagement

    Time frame: Up to 24 months

    Engagement will be measured by the number of primary care visits and number of primary care phone calls over the course of the study period

  4. Treatment Adherence/Receipt

    Time frame: Up to 24 months

    Treatment adherence/receipt measured by the number of mental health visits, number of medication refills, and length of time taken to reach a stable treatment dose.

  5. Clinical Outcomes

    Time frame: Baseline, after 3 months, after 6 months

    Change in symptom severity, measured by the Vanderbilt scale over time Change in functional impairment, measured by the Columbia Impairment Scale (CIS), over time

  6. Goal Attainment

    Time frame: after 3 months, after 6 months

    Parents will identify goals at the study start, and progress toward meeting those goals will be tracked during the study.

  7. Acceptability of the intervention to parents and clinicians

    Time frame: Up to 24 months

    Satisfaction with the intervention will be assessed by parent and clinician responses to open-ended questions about satisfaction, acceptability and unintended consequences of the intervention.

Sponsors and collaborators

Lead sponsor

Children's Hospital of Philadelphia

Other

Registry information

Official study title

Preference and Goal-Directed Primary Care to Minimize Disparities and Improve Outcomes in ADHD

Important dates

Study start
2012
Primary completion
2015
Study completion
2016
First posted
Dec 8, 2011
Registry last updated
Jul 21, 2016

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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