Clinical trial NCT03610373: Testing Psychosocial Treatment Planning Methods for Youth Anxiety and Depression
Official title: Personalizing Treatment Through Shared Decision Making for Youth Psychotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety Disorders
Depressive Disorder
Keywords: anxiety
depression
childhood
therapy
treatment
medical decision making
Lead sponsor: Boston University Charles River Campus
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2018-08-01
Enrollment: 45
Sex: ALL
Minimum age (years): 7
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are randomly assigned to receive a treatment planned primarily by the clinician (clinician guided) or planned collaboratively by the clinician, parent, and child (shared decision-making).
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Anxiety Disorders Interview Schedule for DSM-IV - Child/Parent
timeFrame: Through completion of treatment, anticipated to be an average of 5 months
Secondary outcomes:
measure: Satisfaction with Decision Scale
timeFrame: At the start of treatment, anticipated to be an average of 3 weeks after the initial assessment
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston University
state: Massachusetts
Study officials:
affiliation: Boston University
name: David A Langer, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: