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

NCT01487967 | Completed

• 1 other identifier: 11-008315
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

Attention Deficit Hyperactivity Disorder; ADHD; Preferences; Goals; Decision Making

Outcome Measures

Primary Outcomes (1)

• Feasibility of family recruitment and follow-up

  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.

  Up to 24 months

Secondary Outcomes (7)

• Joint Participation in Decision-Making and Partnership

  Baseline

• Treatment Acceptability

  Baseline, after 3 months, after 6 months

• Parent Engagement

  Up to 24 months

• Treatment Adherence/Receipt

  Up to 24 months

• Clinical Outcomes

  Baseline, after 3 months, after 6 months

Study Arms (2)

Intervention

EXPERIMENTAL

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).

Other: Preference and Goal Instrument

Control

NO INTERVENTION

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

Interventions

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).

Intervention

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Alexander G Fiks, MD, MSCE

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2011
• First Posted: December 8, 2011
• Study Start: January 1, 2012
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2016
• Last Updated: July 21, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)