Testing Psychosocial Treatment Planning Methods for Youth Anxiety and Depression

NCT ID: NCT03610373

Last Updated: 2020-01-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-04
• Study Completion Date: 2019-08-27

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Modular Approach to Therapy for Children (MATCH)

Intervention Type: 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

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.

Group Type: ACTIVE_COMPARATOR

Modular Approach to Therapy for Children (MATCH)

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Boston University Charles River Campus

OTHER

Sponsor Role: lead

Responsible Party

David A. Langer

Research Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David A Langer, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Boston University

Locations

Boston University

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

K23MH101238

Identifier Type: NIH

Identifier Source: secondary_id

View Link

3462

Identifier Type: -

Identifier Source: org_study_id