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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT02229305 |
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Date of registration:
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28/08/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Maine Implementation Study - Phase III
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Scientific title:
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Child System and Treatment Enhancement Projects (Child STEPs); The Clinic Treatment Project in Maine - Phase III |
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Date of first enrolment:
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December 2008 |
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Target sample size:
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235 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT02229305 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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United States
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Contacts
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Name:
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John R Weisz, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Harvard University |
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Key inclusion & exclusion criteria
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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
Age minimum:
6 Years
Age maximum:
15 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Anxiety
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Problem Behavior
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Depression
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Trauma
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Intervention(s)
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Behavioral: Modular Approach to Therapy for Children
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Behavioral: Usual Care Treatment
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Primary Outcome(s)
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Brief Problem Checklist (BPC, parent and child forms)
[Time Frame: Change over time from Day 1 to Day 242 (end of treatment)]
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Top Problems Assessment
[Time Frame: Change over time from Day 1 to Day 735 (24-month follow-up)]
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Secondary Outcome(s)
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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)]
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UCLA PTSD Index
[Time Frame: Change over time from Day 1 to Day 735 (24-month follow-up)]
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Services for Children and Adolescents - Parent Interview (SCAPI)
[Time Frame: Change over time from Day 1 to Day 735 (24-month follow-up)]
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Youth Self Report (YSR)
[Time Frame: Change over time from Day 1 to Day 735 (24-month follow-up)]
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Child Behavior Checklist
[Time Frame: Change over time from Day 1 to Day 735 (24-month follow-up)]
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Therapeutic Alliance Scale for Children
[Time Frame: Post-treatment (Day 267)]
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Brief Impairment Scale
[Time Frame: Change over time from Day 1 to Day 735 (24-month follow-up)]
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Secondary ID(s)
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STEPs Phase III
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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