Testing Psychosocial Treatment Planning Methods for Youth Anxiety and Depression

NCT03610373 | Completed

• 2 other identifiers: 3462K23MH101238
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety Disorders; Depressive Disorder

Keywords

anxiety; depression; childhood; therapy; treatment; medical decision making

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Satisfaction with Decision Scale

  At the start of treatment, anticipated to be an average of 3 weeks after the initial assessment

Study Arms (2)

Shared Decision Making

EXPERIMENTAL

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)

Clinician Guided

ACTIVE COMPARATOR

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)

Interventions

Modular Approach to Therapy for Children (MATCH) BEHAVIORAL

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.

Clinician Guided; Shared Decision Making

Eligibility Criteria

• Age: 7 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston University Charles River Campus: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Boston University

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Anxiety Disorders; Depressive Disorder; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Mood Disorders; Behavioral Symptoms; Behavior

Study Officials

• David A Langer, Ph.D.

  Boston University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcomes assessors do not have access to data regarding which arm each participant is in.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Associate Professor

Model Details: 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).

Study Record Dates

• First Submitted: June 29, 2018
• First Posted: August 1, 2018
• Study Start: October 4, 2016
• Primary Completion: February 20, 2019
• Study Completion: August 27, 2019
• Last Updated: January 28, 2020

Record last verified: 2020-01

Locations

US (1)