Common Engagement Strategies (Common Factors) for Childhood Anxiety
Primary Purpose
Anxiety
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Common factors engagement training for provider
Standard pediatric advice for childhood anxiety
Sponsored by
About this trial
This is an interventional treatment trial for Anxiety
Eligibility Criteria
Inclusion Criteria:
- Coming for well-child visit to designated clinical site;
- SCARED score 25 or greater
Exclusion Criteria:
- acute medical illness, SCARED 40 or greater
Sites / Locations
- Georgetown University Pediatric Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Common factors intervention
Control
Arm Description
Children and parents in this arm will be cared for by a provider who has received brief training in common factors patient engagement skills (the intervention) for use in addition to standard anxiety-related advice. Thus this arm will receive common factors engagement training for provider.
Children and parents in this arm will be cared for by a provider who is able to offer standard pediatric anxiety-related advice (the control intervention). Families will receive standard pediatric advice for childhood anxiety.
Outcomes
Primary Outcome Measures
The Screen for Child Anxiety Related Emotional Disorders (SCARED)
Re-test on short inventory of anxiety-related symptoms
Secondary Outcome Measures
Full Information
NCT ID
NCT02441569
First Posted
May 8, 2015
Last Updated
May 5, 2017
Sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborators
Georgetown University
1. Study Identification
Unique Protocol Identification Number
NCT02441569
Brief Title
Common Engagement Strategies (Common Factors) for Childhood Anxiety
Official Title
Common Engagement Strategies (Common Factors) for Childhood Anxiety
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborators
Georgetown University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This trial examines the effectiveness of training pediatric primary care providers (nurse practitioners, doctors) to use of strategies that enhance family/youth empowerment and engagement during office visits for children with mild to moderate problems with anxiety. Children coming for routine care at one clinic are screened for anxiety symptoms and seen by either a specially trained provider or one of the clinic's other regular staff members.
Detailed Description
Children who are thought to have mild to moderate anxiety will, via their parents, be offered the opportunity to receive treatment from their pediatric primary care provider. Providers will either use their existing anxiety approaches or will use those approaches combined with extra communication skills designed to promote patient and parent engagement in care. Children will be seen for up to 4 30-minute visits at 2 week intervals, with a follow-up telephone call 3 months later to asses the impact of treatment. Children with more severe anxiety (or those whose parents so desire) will be referred for specialized mental health care.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Common factors intervention
Arm Type
Experimental
Arm Description
Children and parents in this arm will be cared for by a provider who has received brief training in common factors patient engagement skills (the intervention) for use in addition to standard anxiety-related advice. Thus this arm will receive common factors engagement training for provider.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Children and parents in this arm will be cared for by a provider who is able to offer standard pediatric anxiety-related advice (the control intervention). Families will receive standard pediatric advice for childhood anxiety.
Intervention Type
Behavioral
Intervention Name(s)
Common factors engagement training for provider
Intervention Description
Primary care providers have received brief training in communication skills designed to promote family engagement in care including understanding of treatment and empowerment.
Intervention Type
Behavioral
Intervention Name(s)
Standard pediatric advice for childhood anxiety
Intervention Description
Providers will be free to use their existing knowledge of anxiety problems to offer routine counseling.
Primary Outcome Measure Information:
Title
The Screen for Child Anxiety Related Emotional Disorders (SCARED)
Description
Re-test on short inventory of anxiety-related symptoms
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:
Coming for well-child visit to designated clinical site;
SCARED score 25 or greater
Exclusion Criteria:
acute medical illness, SCARED 40 or greater
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lawrence S Wissow, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Georgetown University Pediatric Clinic
City
Washington, D.C.
State/Province
District of Columbia
ZIP/Postal Code
20057
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Common Engagement Strategies (Common Factors) for Childhood Anxiety
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