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Student Outcomes of Integrative Mental Health Services

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ClinicalTrials.gov Identifier: NCT02877875
Recruitment Status : Recruiting
First Posted : August 24, 2016
Last Update Posted : August 24, 2016
Sponsor:
Information provided by (Responsible Party):
John Weisz, Harvard University

Brief Summary:
The study will compare the impact of Child STEPs (see Weisz et al., 2012) versus usual school-based therapy on students' mental health and school-related outcomes, and test whether changes in school outcomes are mediated by changes in student mental health.

Condition or disease Intervention/treatment
Anxiety Depression Trauma Behavior Problems Behavioral: Modular Approach to Therapy for Children with Anxiety, Depression, Trauma, and Conduct Problems Other: Monitoring and Feedback System Behavioral: Treatment as usual

Detailed Description:
This project will implement and evaluate the Child STEPs (see Weisz et al., 2012) treatment approach through a randomized controlled trial (RCT) at eight K-8 public schools. The STEPs model has two components: (1) a modular protocol that combines 33 modules—i.e., descriptions of common elements within evidence-based therapies for anxiety, depression, post-traumatic stress, and conduct problems; and (2) a web-based system for monitoring student responses to treatment and providing weekly feedback to therapists, to guide their selection and sequencing of the STEPs modules. The project will include an evaluation of the effectiveness of STEPS compared to "treatment as usual" (known as Usual Care or UC) on students' mental health and school-related outcomes, and an analysis of whether changes in school outcomes are mediated by changes in student mental health.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 168 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Student Outcomes of Integrative Mental Health Services
Study Start Date : January 2015
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Child STEPS
Child STEPs includes (1) a treatment protocol, Modular Approach to Therapy for Children with Anxiety, Depression, Trauma or Conduct Problems (MATCH-ADTC;Chorpita & Weisz, 2009), and (2) a youth monitoring and feedback system (MFS).
Behavioral: Modular Approach to Therapy for Children with Anxiety, Depression, Trauma, and Conduct Problems
MATCH-ADTC (Chorpita & Weisz, 2009) is designed for children aged 6-15. Unlike most evidence-based treatments (EBTs), which focus on single disorder categories (e.g., anxiety only), MATCH is designed for multiple disorders and problems encompassing anxiety, depression, post-traumatic stress, and disruptive conduct, including the conduct problems associated with ADHD. MATCH is composed of 33 modules—i.e., specific treatment procedures derived from decades of research on EBTs. The various modules can be organized and sequenced flexibly to tailor treatment to each child's characteristics and needs.
Other Names:
  • MATCH
  • MATCH - ADTC
Other: Monitoring and Feedback System
For each child, the web-based MFS system provides weekly monitoring of the MATCH modules used and the child's treatment response, in two forms (a) changes on the Behavior and Emotions Survey and (b) changes in severity of the top treatment concerns identified by youths and caregivers. At the end of treatment, the MFS provides a complete record of modules used, and child treatment response, across all the weeks of treatment.
Other Name: MFS
Active Comparator: Usual Care
Treatment in the UC condition will use the procedures therapists and their supervisors consider appropriate and believe to be effective, and researchers will not influence their work.
Behavioral: Treatment as usual
Treatment in the UC condition will use the procedures therapists and their supervisors consider appropriate and believe to be effective.
Other Names:
  • Usual Care
  • UC



Primary Outcome Measures :
  1. Change from Baseline Behavior and Emotions Survey (BES) at End of Treatment, at 6-month Follow-Up, and Weekly and Monthly Progress Monitoring [ Time Frame: Weekly for families (monthly for teachers) from baseline to the end of treatment, assessed up to 40 weeks, and 6 month follow-up ]
    The current version of the BES contains 29 items that were constructed based on the verbatim reports of parents and children who were asked to describe the child's emotional and behavioral problems that were of most concern to them (see Weisz et al., 2011), as well as on findings of previous factor analytic studies that identified emotional/internalizing/overcontrolled and conduct/externalizing/undercontrolled clusters of child or adolescent problems (e.g., Goodman, Lamping, & Ploubidis, 2010). Children and caregivers complete the BES at baseline, weekly during the course of treatment, post-treatment, and at 6 month follow-up. Caregivers complete the BES at baseline, weekly during the course of treatment, post-treatment, and at 6 month follow-up.

  2. Change from Baseline Top Problems Assessment (TPA) at End of Treatment, at 6-month Follow-Up, and Weekly and Monthly Progress Monitoring [ Time Frame: Weekly for families (monthly for teachers) from baseline to the end of treatment, assessed up to 40 weeks, and 6 month follow-up ]
    The TPA (Weisz et al., 2011), also administered weekly for families (monthly for teachers), consists of youth, caregiver, and teacher ratings of the top three problems youth, caregiver and teacher, respectively, identify as most important to them in structured pre-treatment assessments. In psychometric analyses, the TPA has shown excellent test-retest reliability and strong convergent and discriminant validity relative to standardized measures of child psychopathology. In outpatient care, the TPA has shown excellent sensitivity to change over time, and substantial correlations between Top Problem slopes and standardized measure slopes.

  3. Change from Baseline National Survey of American Families (NSAF) Parent School Engagement Scale at End of Treatment, at 6-month Follow-Up, and Weekly Progress Monitoring [ Time Frame: Weekly from baseline to the end of treatment, assessed up to 40 weeks, and 6 month follow-up ]
    The National Survey of American Families (NSAF) Parent School Engagement Scale is a telephone-administered, caregiver-report measure of school engagement for students aged 6-17. Caregivers are asked how well the following statements describe their child: (1) cares about doing well in school, (2) only works on schoolwork when forced to, (3) does just enough schoolwork to get by, and (4) always does homework. The scale will be administered weekly by phone.

  4. Academic outcomes, assessed via school grades and standardized test performance [ Time Frame: Yearly, assessed up to 52 weeks ]
    Academic outcomes as obtained through class grades and standardized school testing


Secondary Outcome Measures :
  1. Youth Self-Report (YSR) [ Time Frame: Change over time from Day 1 to 6 month follow-up ]
    Self-report measure of child behavioral and emotional problems. Each item is rated 0 (Not True), 1 (Somewhat or Sometimes True), or 2 (Very True or Often True). Measure generates a total problems scale, broadband Internalizing and Externalizing syndrome scales, and eight narrowband syndrome scales (e.g., Aggressive Behavior). The YSR is supported by extensive psychometric evidence (see Achenbach & Rescorla, 2001). Children completed the YSR at baseline, post-treatment, and 6 month follow-up.

  2. Child Behavior Checklist (CBCL) [ Time Frame: Change over time from Day 1 to 6 month follow-up ]
    Caregiver-report measure of child behavioral and emotional problems. Each item is rated 0 (Not True), 1 (Somewhat or Sometimes True), or 2 (Very True or Often True). Measure generates a total problems scale, broadband Internalizing and Externalizing syndrome scales, and eight narrowband syndrome scales (e.g., Aggressive Behavior). The CBCL is supported by extensive psychometric evidence (see Achenbach & Rescorla, 2001). Caregivers completed the CBCL at baseline, post-treatment, and 6 month follow-up.

  3. Teacher Report Form (TRF) [ Time Frame: Change over time from Day 1 to 6 month follow-up ]
    Teacher-report measure of child behavioral and emotional problems. Each item is rated 0 (Not True), 1 (Somewhat or Sometimes True), or 2 (Very True or Often True). Measure generates a total problems scale, broadband Internalizing and Externalizing syndrome scales, and eight narrowband syndrome scales (e.g., Aggressive Behavior). The TRF is supported by extensive psychometric evidence (see Achenbach & Rescorla, 2001). Teachers completed the TRF at baseline, post-treatment, and 6 month follow-up.

  4. UCLA Post-traumatic Stress Disorder Reaction Index [ Time Frame: Change over time from Day 1 to 6 month follow-up ]
    This 38-item measure is widely-used to assess child post-traumatic stress symptoms . Part I is a brief lifetime trauma screen. If the participant identifies significant trauma, Part II assesses DSM-IV PTSD symptoms related to the trauma. Part III assesses frequency of posttraumatic stress symptoms during the past month. It will be administered separately to students and their caregivers at pre-treatment, to determine whether post-traumatic stress should be a focus of treatment, and will be re-administered at post-treatment and 6 month follow-up to assess change.

  5. Services Assessment for Children and Adolescents (SACA) [ Time Frame: Change over time from Day 1 to 6-month follow-up ]
    To assess whether treatment reduced the need for other services, SACA, a standardized parent-report interview assessing use of multiple mental health services (e.g., medication for a behavioral or emotional problem, inpatient psychiatric hospitalization) will be administered. At pre-treatment, the reporting time frame will be the previous 6 months, to establish a baseline for each student; at post-treatment, the time frame will be the period when treatment was received; at follow-up, the time frame will be the 6 months since treatment ended.

  6. Therapeutic Alliance Scale (TASC) [ Time Frame: Post-treatment, assessed up to 40 weeks after baseline ]
    Students and caregivers will be given the TASC, to assess the quality of the student's working alliance with the therapist. This 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).

  7. Caregiver Satisfaction Questionnaire [ Time Frame: Post-treatment, assessed up to 40 weeks after baseline ]
    Caregivers complete the Caregiver Satisfaction Questionnaire at post-treatment, assessed up to 40 weeks after baseline. The Caregiver Satisfaction Questionnaire is 8 questions (e.g., "How would you rate the quality of the counseling services that were provided?").

  8. Youth Satisfaction Questionnaire [ Time Frame: Post-treatment, assessed up to 40 weeks after baseline ]
    Children complete the Youth Satisfaction Questionnaire at post-treatment, assessed up to 40 weeks after baseline. The Youth Satisfaction Questionnaire is 8 questions (e.g., "Overall, how happy are you with the help you got?").

  9. Therapist Satisfaction Inventory (TSI) [ Time Frame: Post-treatment, assessed up to 40 weeks after baseline ]
    When a child and/or family has completed treatment, the therapist completes the 16-item TSI, derived from Addis & Krasnow's (2000) report on therapist attitudes toward manualized treatments. The measure assesses whether therapists liked the treatment approach they used, whether the approach made them feel effective, whether they believe it allowed them to individualize treatment to fit the needs of the client, and whether it seems appropriate for the kinds of children they most often see.

  10. Emotion Regulation Checklist (ERC) [ Time Frame: Change over time from Day 1 to 6 month follow-up ]
    The ERC (Shields& Cicchetti, 1997) is a 24-item questionnaire using a 4-point Likert scale that assesses the caregiver's perceptions of their children's ability to manage emotion. This measure yields two empirically derived scales: (a) Emotion Regulation that assesses situationally appropriate affective displays and emotional self-awareness, and (b) Lability/Negativity, which measures mood lability and culturally inappropriate affective displays. Internal consistency has been established for this measure as well as support for its construct validity. Caregivers complete the ERC at baseline, post-treatment, and 6-month follow-up.

  11. Brief Symptom Inventory (BSI) [ Time Frame: Baseline ]
    Parents complete this 53-item, self-report measure of adult symptomatology at baseline. This measure generates scores on nine dimensions (e.g., Depression, Anxiety, Hostility) and a General Severity Index (GSI).

  12. The Children's Emotion Management Scale (CEMS) [ Time Frame: Change over time from Day 1 to 6 month follow-up ]
    The CEMS (Zeman et al., 2001) assesses children's self-report of sadness, anger, and worry regulation. Children indicate the frequency with which they engage in a variety of emotion management strategies using a Likert scale of 1 (hardly ever), 2 (sometimes), or 3 (often). Three subscales have been identified for each emotion: (a) Inhibition (four items),(b) Dysregulated Expression (three items), and (c) Emotion Regulation Coping (five items for sadness scale and four items for anger scale). Examination of the reliability of the CEMS anger and sadness scales indicate coefficient alphas that range from .62 to .77 and test-retest reliability ranging from .61 to .80 for the individual subscales. Children complete the CEMS at baseline, post-treatment, and 6 month follow-up.

  13. The Children's Response Style Questionnaire (CRSQ) [ Time Frame: Baseline ]
    The CRSQ is modeled after Nolen-Hoeksema's Response Styles Questionnaire (Nolen-Hoeksema & Morrow, 1991). The CRSQ consists of 25 items, each of which describes a particular response to symptoms of depression. The items are grouped into three scales: (1) Ruminative Response subscale (CRSQ-Rumination); (2) Distracting Response subscale (CRSQ-Distraction); and (3) Problem-Solving subscale (CRSQ-Problem solving). For each item, children are asked to indicate how often they respond in this way when they are feeling sad (almost never = 0,sometimes = 1, often = 2, or almost always = 3). Scores range from 0 to 39 on the Ruminative Response subscale, from 0 to 21 on the Distracting Response subscale, and from 0 to 15 on the Problem Solving subscale. Higher scores on each subscale indicate a greater tendency to engage in that particular response style.Children complete the CRSQ at baseline.

  14. Perceived Control Scale for Children (PCSC) [ Time Frame: Change over time from Day 1 to 6 month follow-up ]
    The PCSC (Weisz et al., 2001) assesses perceived ability to exert primary control—that is, to influence or alter objective events or conditions through one's own effort. Children rate agreement with statements about their ability to exert primary control, with half the items worded in a positive direction (e.g., "I can do well on tests if I study hard.") and half in a negative direction (e.g., "I cannot get other kids to like me no matter how hard I try."). Responses can range from "very true" to "very false." This scale has shown acceptable internal consistency (α=0.88) and six-month test-retest reliability (r=0.57) as well as a strong inverse relation to depressive symptoms (r=0.58 with Children's Depression Inventory scores) (Weisz et al. 2001).

  15. Secondary Control Scale for Children (SCSC) [ Time Frame: Change over time from Day 1 to 6 month follow-up ]
    This 20-item scale was designed to assess perceived ability to exert secondary control—that is, to influence the personal psychological impact of objective conditions on oneself, by adjusting oneself to fit those conditions. The item content reflects response patterns associated with secondary control in the two-process model (Rothbaum et al. 1982; Weisz et al. 1984a,b)—for example, finding a silver lining, adjusting cognition, avoiding rumination, and generic secondary control. To discourage response sets, half the items are worded in a positive direction and half in a negative direction. Respondents rate their agreement with each item (on a 4-point scale, from "very false" to "very true").

  16. Implicit Theories of Personality Measure [ Time Frame: Change over time from Day 1 to 6 month follow-up ]
    At baseline, post-treatment, and 6 month follow-up, students were given three items used in previous research to assess children's implicit theories of personality ( e.g., "You have a certain personality, and it is something that you can't do much about" ). Responses can range from 1 (strongly agree) to 6 (strongly disagree). Responses were averaged and higher values corresponded to stronger endorsement of an incremental theory.

  17. Reduced Aggression and Victimization Scales (RAVS) [ Time Frame: Change over time from Day 1 to 6 month follow-up ]
    The Reduced Aggression and Victimization Scales (Orpinas and Horne,2006) will be administered at baseline, post-treatment, and 6 month follow-up. RAVS measures the frequency of reporting aggressive behaviors or of being victimized during the previous week prior to the survey. The scales are composed of six items each. Each point represents one instance of aggression or victimization reported by the student.

  18. Implicit Theories of Thoughts, Emotions, and Behaviors Scale (ITEB-Q) [ Time Frame: Change over time from Day 1 to 6 month follow-up ]
    This study includes a new scale adapted from Dweck's work on implicit theories for intelligence (Dweck & Henderson, 1988) to measure implicit theories regarding thoughts, emotions, and behaviors. The ITEB-Q contains twelve items; four items each address implicit theories regarding thoughts, feelings, and behavior. Items on each subscale present extreme incremental theory beliefs (e.g., "When I try, I can control how I feel," "When I feel bad, I can make myself feel better"). Responses are measured using a four-point scale ranging from 1 ("Very False") to 4 ("Very True"). The higher participants' summed scores on the full ITEB-Q, the less they believe thoughts, emotions, and behavior are fixed entities.

  19. Children's Alexithymia Scale (CAS) [ Time Frame: Change over time from Day 1 to 6 month follow-up ]
    The Children's Alexithymia Scale is based on the original Toronto Alexithymia Scale 20 (TAS-20, Bagby, Parker & Taylor, 1994) that assesses alexithymia in adults. The Alexithymia Questionnaire for Children consists of 20 items that represent the three factors: Difficulty identifying feelings, Difficulty describing feelings and Externally oriented thinking. The item response format is: strongly disagree to strongly agree.

  20. Evidence-Based Practice Attitudes Scale (EBPAS) [ Time Frame: Change over time from Day 1 to post-treatment ]
    The EBPAS (Aarons, 2004) consists of 15 items measured on a 5-point scale ranging from 0 (Not at all) to 4 (To a very great extent). The EBPAS is comprised of four subscales (Appeal, Requirements, Oppenness, and Divergence) and a total scale score, which represents respondents' global attitude toward adoption of EBPs. Cronbach's alpha reliability for the EBPAS is good (alpha = 0.77), with subscale alphas ranging from 0.59 to 0.90 (Aarons 2004). Therapist complete this measure at baseline and post-treatment.

  21. Academic Competence Evaluation Scales [ Time Frame: Change over time from Day 1 to 6 month follow-up ]
    School functioning in the classroom will be assessed by teacher reports on the Academic Competence Evaluation Scales (ACES) at baseline, monthly during treatment, at post-treatment and at 6 month follow-up. The ACES assesses Academic Skills (including Reading/Language Arts, Mathematics, and Critical Thinking) and Academic Enablers (including Interpersonal Skills, Engagement, Motivation, and Study Skills).

  22. The School Engagement Measure-MacArthur Network [ Time Frame: Weekly from baseline to the end of treatment, assessed up to 40 weeks, and 6 month follow-up ]
    The School Engagement Measure-MacArthur Network is a student-self report measure of three components of student engagement that have been supported in factor analysis; these are: Behavioral, Emotional and Cognitive. The Cognitive subscale has not fared so well psychometrically, so only the two psychometrically stronger subscales: Behavioral and Emotional Engagement, will be administered weekly to the child.



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Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   7 Years to 13 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Enrolled in grades 3-7
  2. Have a primary clinical problem in the areas of anxiety, depression, conduct, or posttraumatic stress
  3. Clinically elevated problem levels on the Internalizing, Externalizing, Anxious-Depressed, Withdrawn-Depressed, Aggressive Behavior, or Rule-Breaking Behavior scales of the Child Behavior Checklist or Youth Self-Report or on the UCLA Post-traumatic Stress Disorder Reaction Index

Exclusion Criteria:

  1. Mental retardation
  2. Pervasive developmental disorder
  3. Eating disorders
  4. Children for whom attention problems or hyperactivity are the primary referral concern
  5. Active psychosis and/or a suicide attempt in the previous year

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): NCT02877875


Contacts
Contact: John R. Weisz jrw@wjh.harvard.edu

Locations
United States, Massachusetts
Harvard University Recruiting
Cambridge, Massachusetts, United States, 02138
Contact: John R. Weisz, PhD       jrw@wjh.harvard.edu   
Principal Investigator: John R Weisz, PhD         
Sponsors and Collaborators
Harvard University
Investigators
Principal Investigator: John R. Weisz Harvard University

Publications:

Responsible Party: John Weisz, Professor and Primary Investigator, Harvard University
ClinicalTrials.gov Identifier: NCT02877875     History of Changes
Other Study ID Numbers: R305A140253
First Posted: August 24, 2016    Key Record Dates
Last Update Posted: August 24, 2016
Last Verified: August 2016

Keywords provided by John Weisz, Harvard University:
anxiety
depression
trauma
behavior problems
evidence-based treatments
manualized treatments
cognitive-behavioral therapy
youth
mental health

Additional relevant MeSH terms:
Depression
Problem Behavior
Behavioral Symptoms