Common Engagement Strategies (Common Factors) for Childhood Anxiety

• Sponsor: Johns Hopkins Bloomberg School of Public Health
• Collaborator: Georgetown University
• Information provided by (Responsible Party): Johns Hopkins Bloomberg School of Public Health

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.

Condition or disease	Intervention/treatment	Phase
Anxiety	Behavioral: Common factors engagement training for provider; Behavioral: Standard pediatric advice for childhood anxiety	Not Applicable

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	32 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	Common Engagement Strategies (Common Factors) for Childhood Anxiety
Study Start Date :	September 2014
Actual Primary Completion Date :	January 2016
Actual Study Completion Date :	January 2016

Arms and Interventions

Arm	Intervention/treatment
Experimental: Common factors intervention; 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.	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.; Behavioral: Standard pediatric advice for childhood anxiety; Providers will be free to use their existing knowledge of anxiety problems to offer routine counseling.
Active Comparator: Control; 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.	Behavioral: Standard pediatric advice for childhood anxiety; Providers will be free to use their existing knowledge of anxiety problems to offer routine counseling.

Outcome Measures

Primary Outcome Measures :

1. The Screen for Child Anxiety Related Emotional Disorders (SCARED) [ Time Frame: 3 months ]
   Re-test on short inventory of anxiety-related symptoms

Eligibility Criteria

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Ages Eligible for Study:	6 Years to 12 Years (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Locations

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United States, District of Columbia
Georgetown University Pediatric Clinic
Washington, D.C., District of Columbia, United States, 20057

Sponsors and Collaborators

Johns Hopkins Bloomberg School of Public Health

Georgetown University

Investigators

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Principal Investigator:	Lawrence S Wissow, MD	Johns Hopkins University

More Information

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Responsible Party:	Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier:	NCT02441569 History of Changes
Other Study ID Numbers:	P20MH086048 ( U.S. NIH Grant/Contract )
First Posted:	May 12, 2015
Last Update Posted:	May 9, 2017
Last Verified:	May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Additional relevant MeSH terms:

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Anxiety Disorders; Mental Disorders