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OpenTrials
Completed

NCT Number: NCT03610373

Testing Psychosocial Treatment Planning Methods for Youth Anxiety and Depression

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.

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Key information

Age range

7 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Boston University

Boston, Massachusetts, 02215, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Anxiety Disorders Interview Schedule for DSM-IV - Child/Parent

    Time frame: Through completion of treatment, anticipated to be an average of 5 months

    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 outcomes

  1. Satisfaction with Decision Scale

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

    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).

Sponsors and collaborators

Lead sponsor

Boston University Charles River Campus

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Personalizing Treatment Through Shared Decision Making for Youth Psychotherapy

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Aug 1, 2018
Registry last updated
Jan 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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