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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:
NCT01487967
First received: December 5, 2011
Last updated: October 11, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention
Attention Deficit Hyperactivity Disorder
Other: Preference and Goal Instrument

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Preference and Goal-Directed Primary Care to Minimize Disparities and Improve Outcomes in ADHD

Resource links provided by NLM:


Further study details as provided by Children's Hospital of Philadelphia:

Primary Outcome Measures:
  • Feasibility of family recruitment and follow-up [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Joint Participation in Decision-Making and Partnership [ Time Frame: Baseline ] [ Designated as safety issue: No ]

    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


  • Treatment Acceptability [ Time Frame: Baseline, after 3 months, after 6 months ] [ Designated as safety issue: No ]
    Treatment acceptability measured by the Treatment Acceptability Questionnaire, Parent version (TAQ-P).

  • Parent Engagement [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
    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

  • Treatment Adherence/Receipt [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
    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.

  • Clinical Outcomes [ Time Frame: Baseline, after 3 months, after 6 months ] [ Designated as safety issue: No ]
    Change in symptom severity, measured by the Vanderbilt scale over time Change in functional impairment, measured by the Columbia Impairment Scale (CIS), over time

  • Goal Attainment [ Time Frame: after 3 months, after 6 months ] [ Designated as safety issue: No ]
    Parents will identify goals at the study start, and progress toward meeting those goals will be tracked during the study.

  • Acceptability of the intervention to parents and clinicians [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 120
Study Start Date: January 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention Other: Preference and Goal Instrument

Clinicians will receive training on the updated AAP guidelines for ADHD, and receive training on the preference and goal instrument and on directing care toward preferences and goals.

Parents will receive education on ADHD and its treatment, and on the preference and goal instrument, will complete the preference and goal instrument, use it in the ADHD treatment decision-making process, and have preferences and goals tracked over time.

No Intervention: Control

Clinicians will receive training on the updated American Academy of Pediatrics (AAP) guidelines for ADHD.

Parents will receive education on ADHD and its treatment, and otherwise receive standard care.


Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   6 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01487967

Locations
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Children's Hospital of Philadelphia
  More Information

No publications provided

Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT01487967     History of Changes
Other Study ID Numbers: 11-008315
Study First Received: December 5, 2011
Last Updated: October 11, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital of Philadelphia:
Attention Deficit Hyperactivity Disorder
ADHD
Preferences
Goals
Decision Making

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on April 16, 2014