Clinical trial NCT02229305: Maine Implementation Study - Phase III
Official title: Child System and Treatment Enhancement Projects (Child STEPs); The Clinic Treatment Project in Maine - Phase III
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Trauma
Depression
Problem Behavior
Keywords: Anxiety
Trauma
Depression
Problem Behavior
evidence-based treatments
Lead sponsor: Harvard University
Sponsor class: OTHER
Collaborators: name: MacArthur Foundation
name: Casey Family Programs
name: Annie E. Casey Foundation
First posted: 2014-09-01
Enrollment: 235
Sex: ALL
Minimum age (years): 6
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: This study focused on youths aged 6 - 15 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. Using a randomized block design, 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). MATCH-ADTC was supported by training and supervision procedures designed to fit providers and their clinic contexts. Assessments were carried out at pre-treatment, at post-treatment, and at 3-,6-,9-,12,18-,and 24-month follow-ups. Assessments carried out at pre-treatment included (a) individual youth problems and disorders; (b) individual youth functioning at home and school; and (c) clinic staff beliefs and attitudes toward evidence-based treatments. Assessments carried out at post-treatment and follow-ups included measures of (1) youth, caregiver, and therapist satisfaction with treatment; (b) youth, caregiver, and therapist views on the quality of the therapeutic relationship; and (c) treatment costs. Assessments carried out at follow-up only included measures of (a) caregiver reports of any mental health service use following project treatment; (b) therapist reports on the extent to which the treatment procedures they used in the project are continued after project termination. Analyses will address critical questions about deployment of evidence-based youth practices to clinical settings.

Eligibility criteria: Inclusion Criteria:

* 6 - 15 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Brief Problem Checklist (BPC, parent and child forms)
timeFrame: Change over time from Day 1 to Day 242 (end of treatment)
measure: Top Problems Assessment
timeFrame: Change over time from Day 1 to Day 735 (24-month follow-up)
Secondary outcomes:
measure: UCLA PTSD Index
timeFrame: Change over time from Day 1 to Day 735 (24-month follow-up)
measure: Youth Self Report (YSR)
timeFrame: Change over time from Day 1 to Day 735 (24-month follow-up)
measure: Child Behavior Checklist
timeFrame: Change over time from Day 1 to Day 735 (24-month follow-up)
measure: Therapeutic Alliance Scale for Children
timeFrame: Post-treatment (Day 267)
measure: Service Assessment for Children and Adolescents: Treatment and Auxiliary Service Use Scales
timeFrame: Change over tiem from Day 1 to Day 735 (24-month follow-up)
measure: Brief Impairment Scale
timeFrame: Change over time from Day 1 to Day 735 (24-month follow-up)
measure: Services for Children and Adolescents - Parent Interview (SCAPI)
timeFrame: Change over time from Day 1 to Day 735 (24-month follow-up)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Judge Baker Children's Center
state: Massachusetts
Study officials:
affiliation: Harvard University
name: John R Weisz, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.