Anxiety Disorders Clinical Trial
Official title:
Personalizing Treatment Through Shared Decision Making for Youth Psychotherapy
Verified date | January 2020 |
Source | Boston University Charles River Campus |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Youth depression and anxiety represent a serious public health concern, with affected youth
often experiencing social, familial, and academic impairment. Research evidence supports a
growing array of effective treatments for youth depression and anxiety, yet as the collection
of evidence-based treatments expands, so do the challenges of utilizing the evidence:
clinicians must be able to (1) access, integrate, and apply the available evidence, and (2)
engage in a collaborative process with each family to develop a plan that is responsive to
each family's unique characteristics, preferences, and goals. Engaging caregivers and youths
as active collaborators in the treatment planning process is a patient-centered approach with
the potential to improve the process and outcome of youth mental health care by facilitating
the personalization of established evidence-based treatment approaches. Such collaboration,
frequently referred to as shared decision-making (SDM), is a hallmark of evidence-based
practice and a key feature of federal guidelines for health care delivery. However, despite
growing rhetorical support for SDM, empirical support is lacking, particularly in the area of
youth mental health treatment. The absence of such research is unfortunate, given the
potential for SDM to facilitate the dissemination and implementation of evidence-based
treatments, and to personalize the use of established treatments to increase acceptability,
retention, satisfaction, and overall effectiveness.
The present project tests the feasibility and acceptability of SDM through a pilot randomized
controlled trial of 40 youths (ages 7-15) meeting diagnostic criteria for an anxiety or
depressive disorder. The trial will compare an evidence-based treatment that is planned
collaboratively with youths and caregivers using the SDM protocol, to an evidence-based
treatment that is planned by the clinician and supervisor using pretreatment assessment data.
Eligible youths will received up to 26 treatment sessions at no cost and complete assessments
prior to the start of treatment, at the end of treatment, and six months following the end of
treatment.
Status | Completed |
Enrollment | 45 |
Est. completion date | August 27, 2019 |
Est. primary completion date | February 20, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 7 Years to 15 Years |
Eligibility |
Inclusion Criteria: - a current DSM-5 principal diagnosis of a Major Depressive Disorder, Dysthymic Disorder, Generalized Anxiety Disorder, Separation Anxiety Disorder, Social Phobia, or Specific Phobia - if receiving psychiatric medication, dose will be stable for at least 3 months at enrollment with ability to maintain medication - youth and caregiver speak fluent English Exclusion Criteria: - active suicidality - history of severe physical or mental impairments (e.g., mental retardation, autism spectrum disorders) in youth or caregiver - participation in additional psychosocial treatment |
Country | Name | City | State |
---|---|---|---|
United States | Boston University | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Boston University Charles River Campus | National Institute of Mental Health (NIMH) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Anxiety Disorders Interview Schedule for DSM-IV - Child/Parent | The Anxiety Disorders Interview Schedule for DSM-IV - Child/Parent is an extensively tested semi-structured interview assessing the major anxiety, mood, and externalizing disorders. | Through completion of treatment, anticipated to be an average of 5 months | |
Secondary | Satisfaction with Decision Scale | The 6-item Satisfaction with Decision Scale assesses satisfaction with treatment-related decisions. The scale score ranges from 6 (very low satisfaction) to 30 (very high satisfaction). | At the start of treatment, anticipated to be an average of 3 weeks after the initial assessment |
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