Testing Psychosocial Treatment Planning Methods for Youth Anxiety and Depression

Personalizing Treatment Through Shared Decision Making for Youth Psychotherapy

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.

Study Overview

• Status: Completed
• Conditions: Depressive Disorder; Anxiety Disorders
• Intervention / Treatment: Behavioral: Modular Approach to Therapy for Children (MATCH)

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Boston University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 15 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Shared Decision Making; 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.	Behavioral: Modular Approach to Therapy for Children (MATCH); 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.
Active Comparator: Clinician Guided; 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.	Behavioral: Modular Approach to Therapy for Children (MATCH); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Boston University Charles River Campus
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: David A Langer, Ph.D., Boston University

Study record dates

Study Major Dates

• Study Start (Actual): October 4, 2016
• Primary Completion (Actual): February 20, 2019
• Study Completion (Actual): August 27, 2019

Study Registration Dates

• First Submitted: June 29, 2018
• First Submitted That Met QC Criteria: July 31, 2018
• First Posted (Actual): August 1, 2018

Study Record Updates

• Last Update Posted (Actual): January 28, 2020
• Last Update Submitted That Met QC Criteria: January 27, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: treatment; depression; anxiety; childhood; therapy; medical decision making
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Mood Disorders; Depressive Disorder; Disease; Anxiety Disorders
• Other Study ID Numbers: 3462; K23MH101238 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No