Clinical trial NCT03153904: Connecticut Child STEPs
Official title: Child STEPs for Youth Mental Health in Connecticut
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Depression
Trauma
Behavior Problems
Keywords: anxiety
depression
trauma
behavior problems
evidence-based treatments
manualized treatments
cognitive-behavioral therapy
youth
mental health
Lead sponsor: Harvard University
Sponsor class: OTHER
First posted: 2017-05-15
Enrollment: 210
Sex: ALL
Minimum age (years): 7
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Connecticut Child STEPS is a randomized controlled trail investigating the effectiveness of MATCH-ADTC in treating anxiety, depression, trauma, and/or behavioral problems in children seeking services at four Department of Children and Families (DCF) funded clinics in the state of Connecticut. The study will evaluate child outcomes following two forms of therapist training in the MATCH model.

Detailed description: This randomized controlled trial (RCT) will investigate the effectiveness of a modular, transdiagnostic treatment protocol for youth with anxiety, depression, trauma, and/or behavioral problems (MATCH-ADTC) in four DCF funded clinics in the state of Connecticut. MATCH synthesizes common elements found across dozens of evidence-based treatments into one model that is flexible and responsive to the complex needs of children and families. The RCT will evaluate child outcomes following two forms of therapist training in the MATCH model: (1) the 6-day MATCH training only; (2) the 6-day MATCH training plus weekly ongoing case consultation with a MATCH consultant. Participating children are between the ages of 7 and 15.

Eligibility criteria: Inclusion Criteria:

1. 7 to 15 year old child and their caregivers
2. seeking services at community mental health clinics
3. primary problem or disorder related to anxiety, traumatic stress, depression, or conduct problems, or any combination of the four problems

Exclusion Criteria:

1. child is outside of 7-15 age range
2. child does not have elevations in the areas of anxiety, depression, conduct, or posttraumatic stress
3. child is experiencing other primary clinical problems outside of MATCH focus such as:

   * ADHD identified as primary reason for seeking treatment
   * Schizophrenic spectrum disorder including Major Depressive Disorder with psychotic features
   * Autism spectrum disorder including Pervasive Developmental Disorder, Asperger's Disorder, Child Disintegrative Disorder, Rett's Disorder
   * Eating disorder including Anorexia Nervosa and Bulimia Nervosa
   * Mental Retardation
4. having been hospitalized for suicidal thoughts or behaviors within the past year
5. if the problem area of focus is beyond the scope of outpatient treatment and MATCH (e.g., severe aggression, psychosis, severe current suicidal ideation)
6. if child does not have a primary caregiver that can be involved in treatment and complete research assessments

Primary outcomes:
measure: Brief Problem Monitor (BPM)
timeFrame: Weekly from baseline to the end of treatment, and every three months therafter until 18 month follow-up
measure: Top Problems Assessment (TPA)
timeFrame: Weekly from baseline to the end of treatment, and every three months therafter until 18 month follow-up
Secondary outcomes:
measure: Therapist Satisfaction Inventory (TSI)
timeFrame: Change over time from Day 1 to end of treatment, an average of 22 weeks after baseline
measure: Youth Services Survey for Families (YSS-F)
timeFrame: Post-treatment, an average of 22 weeks after baseline
measure: Youth Self-Report and Child Behavior Checklist
timeFrame: Change over time from Day 1 to 18 month follow-up
measure: Evidence-Based Practice Attitudes Scale (EBPAS)
timeFrame: Post-treatment, an average of 22 weeks after baseline
measure: Early Adolescent Temperament Questionnaire Revised (EATQ-R)
timeFrame: Change over time from Day 1 to 18 month follow-up
measure: Child Satisfaction Survey (CSC)
timeFrame: Post-treatment, an average of 22 weeks after baseline
measure: Therapeutic Alliance Scale for Children (TASC)
timeFrame: Post-treatment, an average of 22 weeks after baseline
Other outcomes:
Locations:
city: Cambridge
country: United States
facility: Harvard University
state: Massachusetts
Study officials:
affiliation: Harvard University
name: John R Weisz, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chorpita, B.F., & Weisz, J.R. (2009). Modular Approach to Therapy for Children with Anxiety, Depression, Trauma, or Conduct Problems (MATCH-ADTC). Satellite Beach, FL: PracticeWise, LLC.
citation: Evans SC, Wei MA, Harmon SL, Weisz JR. Modular Psychotherapy Outcomes for Youth With Different Latent Profiles of Irritability and Emotion Dysregulation. Front Psychiatry. 2021 Apr 16;12:618455. doi: 10.3389/fpsyt.2021.618455. eCollection 2021.
citation: Weisz JR, Thomassin K, Hersh J, Santucci LC, MacPherson HA, Rodriguez GM, Bearman SK, Lang JM, Vanderploeg JJ, Marshall TM, Lu JJ, Jensen-Doss A, Evans SC. Clinician training, then what? Randomized clinical trial of child STEPs psychotherapy using lower-cost implementation supports with versus without expert consultation. J Consult Clin Psychol. 2020 Dec;88(12):1065-1078. doi: 10.1037/ccp0000536.