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Testing Psychosocial Treatment Planning Methods for Youth Anxiety and Depression

Primary Purpose

Anxiety Disorders, Depressive Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Modular Approach to Therapy for Children (MATCH)
Sponsored by
Boston University Charles River Campus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Anxiety Disorders focused on measuring anxiety, depression, childhood, therapy, treatment, medical decision making

Eligibility Criteria

7 Years - 15 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Boston University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Shared Decision Making

Clinician Guided

Arm Description

In this arm, parents and children will participate in a shared decision-making protocol with the clinician to plan their treatment. The treatment options available are established, evidence-based treatment techniques. The shared decision-making protocol was developed for this research project.

In this arm, the clinician will plan the treatment in consultation with their supervisor, and share the treatment plan with the parent and child. The parent and child will have the opportunity to ask questions about the treatment plan (and, if they do not agree, reject the treatment plan), but they are not actively involved in making each decision. This is more typical of usual care.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).

Full Information

First Posted
June 29, 2018
Last Updated
January 27, 2020
Sponsor
Boston University Charles River Campus
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT03610373
Brief Title
Testing Psychosocial Treatment Planning Methods for Youth Anxiety and Depression
Official Title
Personalizing Treatment Through Shared Decision Making for Youth Psychotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
October 4, 2016 (Actual)
Primary Completion Date
February 20, 2019 (Actual)
Study Completion Date
August 27, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston University Charles River Campus
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorders, Depressive Disorder
Keywords
anxiety, depression, childhood, therapy, treatment, medical decision making

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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).
Masking
Outcomes Assessor
Masking Description
The outcomes assessors do not have access to data regarding which arm each participant is in.
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Shared Decision Making
Arm Type
Experimental
Arm Description
In this arm, parents and children will participate in a shared decision-making protocol with the clinician to plan their treatment. The treatment options available are established, evidence-based treatment techniques. The shared decision-making protocol was developed for this research project.
Arm Title
Clinician Guided
Arm Type
Active Comparator
Arm Description
In this arm, the clinician will plan the treatment in consultation with their supervisor, and share the treatment plan with the parent and child. The parent and child will have the opportunity to ask questions about the treatment plan (and, if they do not agree, reject the treatment plan), but they are not actively involved in making each decision. This is more typical of usual care.
Intervention Type
Behavioral
Intervention Name(s)
Modular Approach to Therapy for Children (MATCH)
Intervention Description
MATCH is a collection of 31 modules that correspond to the treatment procedures included in standard evidence-based treatments for youth depression, anxiety, and behavioral disorders.
Primary Outcome Measure Information:
Title
Anxiety Disorders Interview Schedule for DSM-IV - Child/Parent
Description
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.
Time Frame
Through completion of treatment, anticipated to be an average of 5 months
Secondary Outcome Measure Information:
Title
Satisfaction with Decision Scale
Description
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).
Time Frame
At the start of treatment, anticipated to be an average of 3 weeks after the initial assessment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David A Langer, Ph.D.
Organizational Affiliation
Boston University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston University
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Testing Psychosocial Treatment Planning Methods for Youth Anxiety and Depression

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