ClinicalTrials.gov
ClinicalTrials.gov Menu

Common Engagement Strategies (Common Factors) for Childhood Anxiety

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02441569
Recruitment Status : Completed
First Posted : May 12, 2015
Last Update Posted : May 9, 2017
Sponsor:
Collaborator:
Georgetown University
Information provided by (Responsible Party):
Johns Hopkins Bloomberg School of Public Health

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 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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

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.




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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02441569


Locations
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
Principal Investigator: Lawrence S Wissow, MD Johns Hopkins University

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    Key Record Dates
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:
Anxiety Disorders
Mental Disorders