NCT02229305

Brief Summary

This study focused on youths who were referred to community-based mental healths clinics for problems related to disruptive behaviors, depression, anxiety, traumatic stress, and any combination of these problems. Therapists were randomly assigned to deliver usual treatment procedures (usual care, or UC) in their clinics or an evidence-based, modularized treatment (Modular Approach to Therapy for Children with Anxiety, Depression, Trauma, or Conduct Problems, or MATCH-ADTC). Assessments were conducted at pre-treatment and post-treatment, and every 3 to 6 months for two years. Results will address critical questions about deployment of evidence-based youth practices to clinical settings.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
235

participants targeted

Target at P75+ for not_applicable anxiety

Timeline
Completed

Started Dec 2008

Longer than P75 for not_applicable anxiety

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2008

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

August 28, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 1, 2014

Completed
Last Updated

September 1, 2014

Status Verified

August 1, 2014

Enrollment Period

3.8 years

First QC Date

August 28, 2014

Last Update Submit

August 28, 2014

Conditions

AnxietyTraumaDepressionProblem Behavior

Keywords

AnxietyTraumaDepressionProblem Behaviorevidence-based treatments

Outcome Measures

Primary Outcomes (2)

  • Brief Problem Checklist (BPC, parent and child forms)

    Youth and parents were contacted weekly to report changes in youth functioning. Each person was asked to rate their own or their child's behavior on 12 items (6 internalizing and 6 externalizing behaviors) that were adapted from the Youth Self Report and the Child Behavior Checklist. Children and caregivers completed the pre-treatment assessment on Day 1, every week during treatment, and at post-treatment assessment which occurred on average 242days (SD = 121 days) after the pre-treatment assessment.

    Change over time from Day 1 to Day 242 (end of treatment)

  • Top Problems Assessment

    Youths and parents were asked to identify "The three most important problems for which you need \[or "your child needs"\] help." at the intake assessment. The six resulting problems (3 from youth, 3 from parent) were then rated on a scale of 0 ("Not serious at all") to 10 ("Very serious problem") by youth and parent. Youths and parents completed the pre-treatment assessment on Day 1, at post-treatment assessment which occurred on average 242 days (SD = 121 days) after the pre-treatment assessment, and at 3-, 6-, 9-, 12- and 24-month follow-up from Day 1. (Used as a measure of clinical outcome.)

    Change over time from Day 1 to Day 735 (24-month follow-up)

Secondary Outcomes (7)

  • UCLA PTSD Index

    Change over time from Day 1 to Day 735 (24-month follow-up)

  • Youth Self Report (YSR)

    Change over time from Day 1 to Day 735 (24-month follow-up)

  • Child Behavior Checklist

    Change over time from Day 1 to Day 735 (24-month follow-up)

  • Therapeutic Alliance Scale for Children

    Post-treatment (Day 267)

  • Service Assessment for Children and Adolescents: Treatment and Auxiliary Service Use Scales

    Change over tiem from Day 1 to Day 735 (24-month follow-up)

  • +2 more secondary outcomes

Study Arms (2)

Usual Care Treatment

ACTIVE COMPARATOR

Usual Care therapists could use any treatment procedures they used regularly in their clinical practice.

Behavioral: Usual Care Treatment

Modular Approach to Therapy for Children

EXPERIMENTAL

Therapists used a modular manual (Modular Approach to Therapy for Children with Anxiety, Depression, Trauma, or Conduct Problems; Chorpita \& Weisz, 2010) to help children with primary problems of anxiety, depression, trauma, and conduct.

Behavioral: Modular Approach to Therapy for Children

Interventions

Usual Care TreatmentBEHAVIORAL

Usual Care therapists could use any treatment procedures they used regularly in their clinical practice.

Usual Care Treatment
Modular Approach to Therapy for ChildrenBEHAVIORAL

Therapists used the Modular Approach to Therapy for Children with Anxiety, Depression, Trauma, or Conduct Problems (MATCH-ADTC; Chorpita \& Weisz, 2010).

Modular Approach to Therapy for Children

Eligibility Criteria

Age6 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • year old and their caregivers
  • seeking services at community mental health clinics
  • primary problem or disorder related to anxiety, traumatic stress, depression, or conduct problems, or any combination of the four problems

You may not qualify if:

  • Child is younger than 6 years or older than 15 years on the day of the phone screen
  • Child has attempted suicide within the past year
  • Schizophrenic spectrum disorders (including MDD with psychotic features)
  • Autism or another Pervasive Developmental Disorder (E.g., PDD NOS, Asperger's Disorder, Child Disintegration Disorder, Rett's Disorder)
  • Anorexia Nervosa
  • Bulimia Nervosa
  • Mental Retardation
  • No relevant T-scores validate target disorders
  • ADHD identified as primary reason for seeking treatment at phone screen
  • Child's medication has not been regulated for one month or longer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Judge Baker Children's Center

Boston, Massachusetts, 02120, United States

Location

Related Publications (7)

  • Chorpita BF, Bernstein A, Daleiden EL; Research Network on Youth Mental Health. Driving with roadmaps and dashboards: using information resources to structure the decision models in service organizations. Adm Policy Ment Health. 2008 Mar;35(1-2):114-23. doi: 10.1007/s10488-007-0151-x. Epub 2007 Nov 6.

    PMID: 17987376BACKGROUND

  • Borntrager CF, Chorpita BF, Higa-McMillan C, Weisz JR. Provider attitudes toward evidence-based practices: are the concerns with the evidence or with the manuals? Psychiatr Serv. 2009 May;60(5):677-81. doi: 10.1176/ps.2009.60.5.677.

    PMID: 19411357BACKGROUND

  • Ebesutani C, Bernstein A, Nakamura BJ, Chorpita BF, Higa-McMillan CK, Weisz JR; The Research Network on Youth Mental Health. Concurrent Validity of the Child Behavior Checklist DSM-Oriented Scales: Correspondence with DSM Diagnoses and Comparison to Syndrome Scales. J Psychopathol Behav Assess. 2010 Sep;32(3):373-384. doi: 10.1007/s10862-009-9174-9. Epub 2009 Nov 27.

    PMID: 20700377BACKGROUND

  • Chorpita BF, Reise S, Weisz JR, Grubbs K, Becker KD, Krull JL; Research Network on Youth Mental Health. Evaluation of the Brief Problem Checklist: child and caregiver interviews to measure clinical progress. J Consult Clin Psychol. 2010 Aug;78(4):526-36. doi: 10.1037/a0019602.

    PMID: 20658809BACKGROUND

  • Ebesutani C, Chorpita BF, Higa-McMillan CK, Nakamura BJ, Regan J, Lynch RE. A psychometric analysis of the Revised Child Anxiety and Depression Scales--parent version in a school sample. J Abnorm Child Psychol. 2011 Feb;39(2):173-85. doi: 10.1007/s10802-010-9460-8.

    PMID: 20878460BACKGROUND

  • Palinkas LA, Schoenwald SK, Hoagwood K, Landsverk J, Chorpita BF, Weisz JR; Research Network on Youth Mental Health. An ethnographic study of implementation of evidence-based treatments in child mental health: first steps. Psychiatr Serv. 2008 Jul;59(7):738-46. doi: 10.1176/ps.2008.59.7.738.

    PMID: 18586990BACKGROUND

  • Weisz JR, Chorpita BF, Palinkas LA, Schoenwald SK, Miranda J, Bearman SK, Daleiden EL, Ugueto AM, Ho A, Martin J, Gray J, Alleyne A, Langer DA, Southam-Gerow MA, Gibbons RD; Research Network on Youth Mental Health. Testing standard and modular designs for psychotherapy treating depression, anxiety, and conduct problems in youth: a randomized effectiveness trial. Arch Gen Psychiatry. 2012 Mar;69(3):274-82. doi: 10.1001/archgenpsychiatry.2011.147. Epub 2011 Nov 7.

    PMID: 22065252BACKGROUND

Related Links

MeSH Terms

Conditions

Anxiety DisordersWounds and InjuriesDepressionProblem Behavior

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehaviorChild Behavior

Study Officials

  • John R Weisz, PhD

    Harvard University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Primary Investigator

Study Record Dates

First Submitted

August 28, 2014

First Posted

September 1, 2014

Study Start

December 1, 2008

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

September 1, 2014

Record last verified: 2014-08

Locations

US(1)