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Completed

NCT Number: NCT02229305

Maine Implementation Study - Phase III

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.

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Key information

Age range

6 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Judge Baker Children's Center

Boston, Massachusetts, 02120, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

usual care treatment

Behavioral

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

Modular Approach to Therapy for Children

Behavioral

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

Primary outcomes

  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 outcomes

  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.)

Sponsors and collaborators

Lead sponsor

Harvard University

Other

Collaborators

  • Annie E. Casey Foundation
  • Casey Family Programs
  • MacArthur Foundation

Registry information

Official study title

Child System and Treatment Enhancement Projects (Child STEPs); The Clinic Treatment Project in Maine - Phase III

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Sep 1, 2014
Registry last updated
Sep 1, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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