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Maine Implementation Study - Phase III

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ClinicalTrials.gov Identifier: NCT02229305
Recruitment Status : Completed
First Posted : September 1, 2014
Last Update Posted : September 1, 2014
Sponsor:
Collaborators:
MacArthur Foundation
Casey Family Programs
Annie E. Casey Foundation
Information provided by (Responsible Party):
John Weisz, Harvard University

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.

Condition or disease Intervention/treatment Phase
Anxiety Trauma Depression Problem Behavior Behavioral: Usual Care Treatment Behavioral: Modular Approach to Therapy for Children Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 235 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Child System and Treatment Enhancement Projects (Child STEPs); The Clinic Treatment Project in Maine - Phase III
Study Start Date : December 2008
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Active Comparator: Usual Care Treatment
Usual Care therapists could use any treatment procedures they used regularly in their clinical practice.
Behavioral: Usual Care Treatment
Usual Care therapists could use any treatment procedures they used regularly in their clinical practice.

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




Primary Outcome Measures :
  1. Brief Problem Checklist (BPC, parent and child forms) [ Time Frame: Change over time from Day 1 to Day 242 (end of treatment) ]
    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.

  2. Top Problems Assessment [ Time Frame: Change over time from Day 1 to Day 735 (24-month follow-up) ]
    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.)


Secondary Outcome Measures :
  1. UCLA PTSD Index [ Time Frame: Change over time from Day 1 to Day 735 (24-month follow-up) ]
    The PTSD Index is a 38-item questionnaire that is widely-used to assess post-traumatic stress symptoms in children. Part I is a brief lifetime trauma screen. If a significant trauma is identified, Part II assesses DSM-IV PTSD symptoms related to the trauma. Part III assesses frequency of post-traumatic stress symptoms during the past month. The measure has shown good convergent validity, strong test-retest reliability, and Cronbach's alpha values in the .90s. We will administer it separately to students and their caregivers at pre-treatment, to determine whether post-traumatic stress should be a focus of treatment, and we will re-administer it at post-treatment and follow-up to assess change over time. 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.)

  2. Youth Self Report (YSR) [ Time Frame: Change over time from Day 1 to Day 735 (24-month follow-up) ]
    The YSR assesses problems in children on eight narrow-band scales (Withdrawn, Somatic Complaints, Anxious, Social Problems, Thought Problems, Attention Problems, Rule-Breaking Behavior, Aggressive Behavior), three broad-band scales (Internalizing, Externalizing, and Total problems), and six DSM-oriented scales. Children 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.)

  3. Child Behavior Checklist [ Time Frame: Change over time from Day 1 to Day 735 (24-month follow-up) ]
    The CBCL assesses problems in children on eight narrow-band scales (Withdrawn, Somatic Complaints, Anxious, Social Problems, Thought Problems, Attention Problems, Rule-Breaking Behavior, Aggression), three broad-band scales (Internalizing, Externalizing, and Total problems), and six DSM-oriented scales. Caregivers completed the pre-treatment assessment on Day 1, at post-treatment assessment which occurred on average 267 days (SD = 124 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.)

  4. Therapeutic Alliance Scale for Children [ Time Frame: Post-treatment (Day 267) ]
    The quality of youths' working alliance with their therapists was assessed via the Therapeutic Alliance Scale for Children (TASC, Shirk & Saiz, 1992). The 7-item scale comes in both a youth-report form and a parent-report form (parents reporting on their youth's relationship with the therapist). On average, children and caregivers completed the post-treatment assessment 267 days (SD = 124 days) after the pre-treatment assessment. (Available for supplemental analyses.)

  5. Service Assessment for Children and Adolescents: Treatment and Auxiliary Service Use Scales [ Time Frame: Change over tiem from Day 1 to Day 735 (24-month follow-up) ]
    The SACA (Horwitz et al., 2001)is a standardized interview for youths and parents that measures use of mental health services across a broad spectrum (including outpatient, inpatient, and school-based). SACA reliability and validity data are well-documented. Caregivers completed the pre-treatment assessment on Day 1, at post-treatment assessment which occurred on average 267 days (SD = 124 days) after the pre-treatment assessment, and at 12- and 24-month follow-up from Day 1.(Available for supplemental analyses.)

  6. Brief Impairment Scale [ Time Frame: Change over time from Day 1 to Day 735 (24-month follow-up) ]
    The BIS is a 23-item instrument that evaluates three domains of functioning: interpersonal relations, school/work functioning, and self-care/self-fulfillment. Its advantages over other global impairment instruments are that it is respondent based, short in administration time, and multidimensional. Caregivers completed the pre-treatment assessment on Day 1, at post-treatment assessment which occurred on average 267 days (SD = 124 days) after the pre-treatment assessment, and at 12- and 24-month follow-up from Day 1.(Available for supplemental analyses.)

  7. Services for Children and Adolescents - Parent Interview (SCAPI) [ Time Frame: Change over time from Day 1 to Day 735 (24-month follow-up) ]
    The SCAPI is a measure that tracks child's use of medication as reported by the parent. Caregivers completed the pre-treatment assessment on Day 1, at post-treatment assessment which occurred on average 267 days (SD = 124 days) after the pre-treatment assessment, and at 3-, 6-, 9-, 12- and 24-month follow-up from Day 1.(Available for supplemental analyses.)



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Ages Eligible for Study:   6 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02229305


Locations
United States, Massachusetts
Judge Baker Children's Center
Boston, Massachusetts, United States, 02120
Sponsors and Collaborators
Harvard University
MacArthur Foundation
Casey Family Programs
Annie E. Casey Foundation
Investigators
Principal Investigator: John R Weisz, PhD Harvard University

Additional Information:
Publications:

Responsible Party: John Weisz, Primary Investigator, Harvard University
ClinicalTrials.gov Identifier: NCT02229305     History of Changes
Other Study ID Numbers: STEPs Phase III
First Posted: September 1, 2014    Key Record Dates
Last Update Posted: September 1, 2014
Last Verified: August 2014

Keywords provided by John Weisz, Harvard University:
Anxiety
Trauma
Depression
Problem Behavior
evidence-based treatments

Additional relevant MeSH terms:
Depression
Problem Behavior
Behavioral Symptoms