NCT02441569

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at below P25 for not_applicable anxiety

Timeline
Completed

Started Sep 2014

Typical duration for not_applicable anxiety

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 8, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 12, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

May 9, 2017

Status Verified

May 1, 2017

Enrollment Period

1.3 years

First QC Date

May 8, 2015

Last Update Submit

May 5, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • The Screen for Child Anxiety Related Emotional Disorders (SCARED)

    Re-test on short inventory of anxiety-related symptoms

    3 months

Study Arms (2)

Common factors intervention

EXPERIMENTAL

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 providerBehavioral: Standard pediatric advice for childhood anxiety

Control

ACTIVE COMPARATOR

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

Interventions

Primary care providers have received brief training in communication skills designed to promote family engagement in care including understanding of treatment and empowerment.

Common factors intervention

Providers will be free to use their existing knowledge of anxiety problems to offer routine counseling.

Common factors interventionControl

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Coming for well-child visit to designated clinical site;
  • SCARED score 25 or greater

You may not qualify if:

  • acute medical illness, SCARED 40 or greater

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Georgetown University Pediatric Clinic

Washington D.C., District of Columbia, 20057, United States

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Lawrence S Wissow, MD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 8, 2015

First Posted

May 12, 2015

Study Start

September 1, 2014

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

May 9, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations