Common Engagement Strategies (Common Factors) for Childhood Anxiety

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.

Study Overview

• Status: Completed
• Conditions: Anxiety
• Intervention / Treatment: Behavioral: Common factors engagement training for provider; Behavioral: Standard pediatric advice for childhood anxiety

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 Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Screen for Child Anxiety Related Emotional Disorders (SCARED)	Re-test on short inventory of anxiety-related symptoms	3 months

Collaborators and Investigators

• Sponsor: Johns Hopkins Bloomberg School of Public Health
• Collaborators: Georgetown University
• Investigators: Principal Investigator: Lawrence S Wissow, MD, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): January 1, 2016

Study Registration Dates

• First Submitted: May 8, 2015
• First Submitted That Met QC Criteria: May 11, 2015
• First Posted (Estimate): May 12, 2015

Study Record Updates

• Last Update Posted (Actual): May 9, 2017
• Last Update Submitted That Met QC Criteria: May 5, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: P20MH086048 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO