AnxietyNCT02441569
Common Engagement Strategies (Common Factors) for Childhood Anxiety
A study testing Common factors engagement training for provider and Standard pediatric advice for childhood anxiety in people with Anxiety, run by Johns Hopkins Bloomberg School of Public Health at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Anxiety
- What is being tested?
- Common factors engagement training for provider and Standard pediatric advice for childhood anxiety
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Jan 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Coming for well-child visit to designated clinical site;
- SCARED score 25 or greater
Who cannot join
- acute medical illness, SCARED 40 or greater
Trial locations and contacts
1 site in 1 country.
United States1 site
Georgetown University Pediatric Clinic
Washington D.C., District of Columbia, 20057
About this study
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.
Read the 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.
- Conditions
- Anxiety
- Being tested
- Common factors engagement training for provider, Standard pediatric advice for childhood anxiety
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Common factors engagement training for providerBehavioural
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 anxietyBehavioural
Providers will be free to use their existing knowledge of anxiety problems to offer routine counseling.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Common factors engagement training for provider; Behavioral: 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. Receives: Behavioral: Standard pediatric advice for childhood anxiety |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Screen for Child Anxiety Related Emotional Disorders (SCARED)
Re-test on short inventory of anxiety-related symptoms
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2015 (estimated)
- Study startSep 2014
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Johns Hopkins Bloomberg School of Public HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- Georgetown University
- Responsible party
- Sponsor
- Investigators
- Lawrence S Wissow, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02441569
- Sponsor's protocol ID
- P20MH086048
- Status last verified
- May 2017
- First submitted
- 8 May 2015
- Last updated
- 9 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Common Engagement Strategies (Common Factors) for Childhood Anxiety
- ClinicalTrials.gov ID
- NCT02441569
- Acronym / sponsor ID
- P20MH086048
- Conditions
- Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- Georgetown University
- Study start
- Sep 2014
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 12 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Common factors intervention | Experimental | Behavioral: Common factors engagement training for provider, Behavioral: Standard pediatric advice for childhood anxietyChildren 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. |
| Control | Active comparator | Behavioral: Standard pediatric advice for childhood anxietyChildren 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. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Coming for well-child visit to designated clinical site;
- SCARED score 25 or greater
Key exclusion criteria (1 listed)
- acute medical illness, SCARED 40 or greater
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Common factors engagement training for providerPrimary care providers have received brief training in communication skills designed to promote family engagement in care including understanding of treatment and empowerment. | Behavioural | Common factors intervention |
| Standard pediatric advice for childhood anxietyProviders will be free to use their existing knowledge of anxiety problems to offer routine counseling. | Behavioural | Common factors intervention, Control |
Primary outcome
The Screen for Child Anxiety Related Emotional Disorders (SCARED)
Time frame: 3 months
Re-test on short inventory of anxiety-related symptoms
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2017.
- Individual participant dataSharing planned: No
Related trials for Anxiety
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lawrence S Wissow, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Common factors engagement training for provider and Standard pediatric advice for childhood anxiety in people with Anxiety, run by Johns Hopkins Bloomberg School of Public Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Screen for Child Anxiety Related Emotional Disorders (SCARED) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2017.