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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02441569
Other study ID # P20MH086048
Secondary ID
Status Completed
Phase N/A
First received May 8, 2015
Last updated May 5, 2017
Start date September 2014
Est. completion date January 2016

Study information

Verified date May 2017
Source Johns Hopkins Bloomberg School of Public Health
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 32
Est. completion date January 2016
Est. primary completion date January 2016
Accepts healthy volunteers No
Gender All
Age group 6 Years to 12 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Common factors engagement training for provider
Primary care providers have received brief training in communication skills designed to promote family engagement in care including understanding of treatment and empowerment.
Standard pediatric advice for childhood anxiety
Providers will be free to use their existing knowledge of anxiety problems to offer routine counseling.

Locations

Country Name City State
United States Georgetown University Pediatric Clinic Washington, D.C. District of Columbia

Sponsors (2)

Lead Sponsor Collaborator
Johns Hopkins Bloomberg School of Public Health Georgetown University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary The Screen for Child Anxiety Related Emotional Disorders (SCARED) Re-test on short inventory of anxiety-related symptoms 3 months
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