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Transitioning Emotionally and Academically to Middle School Successfully (TEAMSS) (TEAMSS)

Primary Purpose

Anxiety Disorders

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Transitioning Emotionally and Academically to Middle School Successfully (TEAMSS)
Sponsored by
UConn Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety Disorders focused on measuring Middle school, Transition, Anxiety

Eligibility Criteria

9 Years - 13 Years (Child)All SexesAccepts Healthy Volunteers

Student:

Inclusion Criteria:

  • be in the last year of a participating elementary school
  • have elevated anxiety symptoms that are their primary concern as indicated by 1) a total SCARED score at baseline of 15 or higher using parent and/or child report, and/or 2) a Clinician Severity Rating (CSR) of 3 or higher on the ADIS
  • read and understand English (both parent and child).

Exclusion Criteria:

  • Students who have a non-anxiety primary mental health concern (e.g., ADHD) will be excluded from TEAMSS, as this intervention is aimed at reducing anxiety and it would not be effective at treating other mental health concerns. Students with comorbid conditions secondary to anxiety will be eligible.

Clinician:

Inclusion Criteria:

  • All clinician participants must be at least a part time employee of a CT MS in the role of school clinician.

Exclusion Criteria:

  • None

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    TEAMSS Intervention in the RCT

    Enhanced Usual Care in the RCT

    Arm Description

    Students randomly assigned to the TEAMSS intervention will receive the 5th and 6th grade components.

    Enhanced Usual Care (EUC) will serve as the comparison group. EUC will be comprised of written materials (given all at once after randomization by study team) for parents and children that include: 1) a specialty mental health referral list; 2) a list of websites and books on child anxiety; and 3) tip sheets on successful transitions to MS. Families in this condition will not be prohibited from seeking treatment (though this will be monitored) for their children. These students will visit and meet with the 6th grade clinician in the spring of 5th grade.

    Outcomes

    Primary Outcome Measures

    Change in Clinical Global Impression - Severity (CGI-S) Scale
    The CGI-S score provides a global rating of anxiety severity ranging from 1= "not at all ill" to 7= "extremely ill".
    Change in Clinical Global Impression - Improvement (CGI-I) Scale
    The CGI-I provides a global rating of clinical improvement in anxiety (relative to baseline) ranging from 1= "very much improved" to 7= "very much worse." Scores of 1-2 are considered "responders."

    Secondary Outcome Measures

    Change in Screen for Child Anxiety Related Emotional Disorders, Child and Parent Versions (SCARED)
    A widely used 41 item measure of childhood anxiety. Informants respond to items using a 3-point Likert-type scale (0 = "not true or hardly ever true", 1 = "somewhat true or sometimes true", 2 = "very true or often true").
    Change in Anxiety Disorders Interview Schedule for DSM-V, Parent and Child Versions (ADIS-V)
    Considered the gold standard for assessing anxiety diagnosis and severity. Impairment ratings are generated for each disorder using the Clinician Severity Rating (CSR, range = 0-8; 4 or higher is required to assign a diagnosis).
    Change in Child Anxiety Impact Scale (CAIS)
    A 27 item measure of anxiety-related interference in social, academic and family functioning. It is scored on a 4-point Likert scale, from 0= "not at all" to 3= "very much."
    Change in School Anxiety Scale - Teacher Report (SAS)
    The SAS is a 16 item questionnaire of student anxiety, items are rated on a 3 point scale (0 = "never" to 3 = "always").
    Change in School Records
    Assess grades, attendance, referrals for special education, grade retention and referrals for disciplinary actions (e.g., suspensions, detentions).
    Change in Academic Competence Evaluation Scale (ACES)
    A 50 item questionnaire, scored on a 5-point Likert scale ranging from "never" to "almost always" that assesses: Academic Skills (reading, mathematics, critical thinking) and Academic Enablers (Motivation, Engagement, Study Skills, Interpersonal Skills).
    Change in Subtests from the Woodcock-Johnson IV Tests of Achievement and Cognitive Abilities (WJ IV)
    These subtests are a widely used, norm-referenced measure of academic achievement and cognitive abilities. Reading, math fluency and numbers reversed will be administered to measure cognitive factors (e.g., efficiency, speed, working memory) that are affected by anxiety.
    Change in Children's Automatic Thoughts Scale (CATS)
    A 40 item questionnaire of maladaptive thoughts associated with anxiety. Items are scored on a 5-point Likert scale from 0= "not at all" to 4= "all the time." To reduce burden, only the Physical and Social Threat subscale will be used.
    Change in Avoidance Hierarchy
    A 3 item measure used in our ongoing studies, which assesses how frequently the student avoids specific anxiety provoking situations from 1 = "never" to 7 = "every time."
    Change in Children's Somatization Inventory (CSI-24)
    A 24 item measure of the child's somatic symptoms (headaches, stomach aches). Items are ranked using a 5 point scale ranging from "not at all" to "a whole lot."
    Change in My Memories of Growing Up (Egna Minnen Beträffande Uppfostran; EMBU)
    A 40 item measure of parental over control and anxious rearing practices associated with higher anxiety. This scale consists of four subscales with 10 items each: overprotection/control, emotional warmth, rejection, and anxious rearing. For purposes of this study, only the overprotection/control and anxious rearing subscales will be used. Items are answered on a 4-point Likert scale ranging from 1= "no," to 4= "yes, most of the time."
    Change in Family Accommodation Scale - Anxiety (FASA)
    A measure of accommodation. Parents respond to 9 items, which are coded on a 5-point Likert scale from 0 = "never" to 4 = "daily."
    Change in Children's Organizational Skills Scale (COSS)
    A 41 item parent, teacher and child measure of organization, planning and time-management. The COSS yields three subscale scores: task planning, organized actions and memory and materials management.
    Change in Children's Global Assessment Scale (CGA-S)
    A measure to assess the student's overall improvement, as a result of participating in the intervention.
    Change in Strength and Difficulties Questionnaire Parent Version (SDQ
    A widely used and psychometrically sound (alpha = .80) 25 item parent report questionnaire that assesses emotional and behavioral difficulties in children 4-17 years old. It yields a total score and five subscale scores: emotion problems, conduct problems, hyperactivity, peer problems and prosocial.
    Change in Revised Child Anxiety and Depression Scale - Depression subscale only (RCADS)
    The RCADS Depression subscale is comprised of 10 items. Youth respond to items using a 4-point Likert-type scale (0-3) to indicate the frequency of symptoms: 'never,' 'sometimes,' 'often,' and 'always.' Higher scores reflect greater frequency of depressive symptoms.

    Full Information

    First Posted
    November 5, 2021
    Last Updated
    September 19, 2023
    Sponsor
    UConn Health
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05145387
    Brief Title
    Transitioning Emotionally and Academically to Middle School Successfully (TEAMSS)
    Acronym
    TEAMSS
    Official Title
    Transitioning Emotionally and Academically to Middle School Successfully: Development of a Brief Intervention to Reduce Student Anxiety (TEAMSS)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 2024 (Anticipated)
    Primary Completion Date
    May 2025 (Anticipated)
    Study Completion Date
    June 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    UConn Health

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Excessive anxiety is a common problem that severely impairs short and long term academic functioning. The transition to middle school (MS) results in increases in anxiety and decreases in academic functioning. Students with anxiety in particular, due to their vulnerability to school-based stressors, are at risk for social, emotional and academic failure during the transition to MS. Unfortunately, the majority of these students do not get identified. Reducing student anxiety has been associated with improvement in academic functioning. Because the transition to MS is inevitable, targeting students with excessive anxiety will help their adjustment to their new school setting, reducing the need for special education and mental health counseling. No interventions exist to help these students with this transition. This study aims to: (1) develop and assess the feasibility of a brief, multi-component intervention, referred to as TEAMSS, Transitioning Emotionally and Academically to Middle School Successfully, to reduce anxiety and improve academic functioning through the transition to MS using an iterative development process (i.e., expert review, two open trials, and small randomized controlled trial (RCT)); (2) conduct a pilot RCT comparing the preliminary impact of TEAMSS, relative to enhanced usual care (EUC), in improving students' social, behavioral, and academic functioning through the transition to MS; and (3) examine theory-based mediators, predictors, and moderators of TEAMSS and assess intervention costs.
    Detailed Description
    The current study will implement two sequential open trials to evaluate the feasibility of TEAMSS and assess intervention acceptability and satisfaction (from children, parents and clinicians). Specifically, data on implementation, acceptability, fidelity and child outcomes will be collected. After each open trial, feedback (via interviews and standardized measures) from students, parents and clinicians will be integrated and presented to the TEAMSS Development Workgroup (TDW) for revision. Potentially eligible 5th grade students (approximately n = 10) will complete the consent process and conduct baseline 1 evaluations. Eligible 5th grade students will meet with the 6th grade school clinician for a school tour and meeting, and will receive written material to foster the successful transition to MS. Immediately prior to starting 6th grade, these students will be contacted and re-evaluated (baseline 2) using an abbreviated assessment to confirm eligibility. Within the first 10 weeks of 6th grade, school clinicians will implement TEAMSS with enrolled students and their parents/teachers. Ten weeks after TEAMSS begins, a post assessment will be completed (i.e., in December) followed by an 8-month follow-up, near the end of the school year (i.e., in May). This process will be repeated for open trial 2 with the exclusion of the 8-month follow-up. The pilot RCT will be conducted with 4-6 school-based clinicians from 4-6 MSs. Approximately 42 5th grade students from 12 elementary schools (approximately 3-6 students per group) with elevated anxiety will be recruited. The RCT will be conducted in 3 phases: Phase 1 - Recruitment, Screening, Baseline Evaluation and Randomization: In Phase 1, 5th grade students will be referred to study staff for screening and evaluation from 5th grade teachers, clinicians and parents and self-referrals. Interested parents and students will contact study staff and complete a brief phone screen (see Recruitment section). Families who pass the screen will complete informed consent and the full baseline evaluation (consisting of a diagnostic interview and questionnaires) with an Independent Evaluator. Families who pass the baseline evaluation will be considered for eligibility. Phase 2 - Intervention and Monitoring: Eligible students will receive TEAMSS (n = 21) or EUC (n= 21) depending on their random assignment. Students in both groups will receive the 5th grade components but only students randomized to TEAMSS will receive the TEAMSS group sessions (in 6th grade), delivered over 10 weeks. During the 10 weeks of TEAMSS, parents of students will attend two group meetings and clinicians will consult with at least one teacher (usually the advisory/homeroom teacher). Phase 3 - Post- and Follow-up Evaluations: At the end of the 10-week intervention phase, students in both groups will complete the post-intervention (3 months into transition year i.e., December). Five months after the intervention ends (8 months into the transition year i.e., May), students in both groups will complete a follow up evaluation to assess the durability of the intervention. A seventh group with students, and a third group for parents, occurring approximately four weeks after session 6 will be conducted to debrief (discuss their experience in the program), ask them about any lingering questions or concerns related to anxiety, and update them on what was learned.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Anxiety Disorders
    Keywords
    Middle school, Transition, Anxiety

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    42 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    TEAMSS Intervention in the RCT
    Arm Type
    Experimental
    Arm Description
    Students randomly assigned to the TEAMSS intervention will receive the 5th and 6th grade components.
    Arm Title
    Enhanced Usual Care in the RCT
    Arm Type
    No Intervention
    Arm Description
    Enhanced Usual Care (EUC) will serve as the comparison group. EUC will be comprised of written materials (given all at once after randomization by study team) for parents and children that include: 1) a specialty mental health referral list; 2) a list of websites and books on child anxiety; and 3) tip sheets on successful transitions to MS. Families in this condition will not be prohibited from seeking treatment (though this will be monitored) for their children. These students will visit and meet with the 6th grade clinician in the spring of 5th grade.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Transitioning Emotionally and Academically to Middle School Successfully (TEAMSS)
    Intervention Description
    Students randomized to TEAMSS will receive reading materials on transitioning to middle school and a a school tour with the middle school clinician (in 5th grade) and the TEAMSS group sessions (in 6th grade) delivered over 10 weeks. During the 10 weeks of TEAMSS, parents of students will attend two group meetings and clinicians will consult with at least one teacher (usually the advisory/homeroom teacher).
    Primary Outcome Measure Information:
    Title
    Change in Clinical Global Impression - Severity (CGI-S) Scale
    Description
    The CGI-S score provides a global rating of anxiety severity ranging from 1= "not at all ill" to 7= "extremely ill".
    Time Frame
    Change from baseline (before intervention) to follow up at 8 months
    Title
    Change in Clinical Global Impression - Improvement (CGI-I) Scale
    Description
    The CGI-I provides a global rating of clinical improvement in anxiety (relative to baseline) ranging from 1= "very much improved" to 7= "very much worse." Scores of 1-2 are considered "responders."
    Time Frame
    Change from post intervention evaluation to follow up at 8 months
    Secondary Outcome Measure Information:
    Title
    Change in Screen for Child Anxiety Related Emotional Disorders, Child and Parent Versions (SCARED)
    Description
    A widely used 41 item measure of childhood anxiety. Informants respond to items using a 3-point Likert-type scale (0 = "not true or hardly ever true", 1 = "somewhat true or sometimes true", 2 = "very true or often true").
    Time Frame
    Change from baseline (before intervention) to follow up at 8 months
    Title
    Change in Anxiety Disorders Interview Schedule for DSM-V, Parent and Child Versions (ADIS-V)
    Description
    Considered the gold standard for assessing anxiety diagnosis and severity. Impairment ratings are generated for each disorder using the Clinician Severity Rating (CSR, range = 0-8; 4 or higher is required to assign a diagnosis).
    Time Frame
    Change from baseline (before intervention) to follow up at 8 months
    Title
    Change in Child Anxiety Impact Scale (CAIS)
    Description
    A 27 item measure of anxiety-related interference in social, academic and family functioning. It is scored on a 4-point Likert scale, from 0= "not at all" to 3= "very much."
    Time Frame
    Change from baseline (before intervention) to follow up at 8 months
    Title
    Change in School Anxiety Scale - Teacher Report (SAS)
    Description
    The SAS is a 16 item questionnaire of student anxiety, items are rated on a 3 point scale (0 = "never" to 3 = "always").
    Time Frame
    Change from baseline (before intervention) to follow up at 8 months
    Title
    Change in School Records
    Description
    Assess grades, attendance, referrals for special education, grade retention and referrals for disciplinary actions (e.g., suspensions, detentions).
    Time Frame
    Change from baseline (before intervention) to follow up at 8 months
    Title
    Change in Academic Competence Evaluation Scale (ACES)
    Description
    A 50 item questionnaire, scored on a 5-point Likert scale ranging from "never" to "almost always" that assesses: Academic Skills (reading, mathematics, critical thinking) and Academic Enablers (Motivation, Engagement, Study Skills, Interpersonal Skills).
    Time Frame
    Change from baseline (before intervention) to follow up at 8 months
    Title
    Change in Subtests from the Woodcock-Johnson IV Tests of Achievement and Cognitive Abilities (WJ IV)
    Description
    These subtests are a widely used, norm-referenced measure of academic achievement and cognitive abilities. Reading, math fluency and numbers reversed will be administered to measure cognitive factors (e.g., efficiency, speed, working memory) that are affected by anxiety.
    Time Frame
    Change from baseline (before intervention) to follow up at 8 months
    Title
    Change in Children's Automatic Thoughts Scale (CATS)
    Description
    A 40 item questionnaire of maladaptive thoughts associated with anxiety. Items are scored on a 5-point Likert scale from 0= "not at all" to 4= "all the time." To reduce burden, only the Physical and Social Threat subscale will be used.
    Time Frame
    Change from baseline (before intervention) to follow up at 8 months
    Title
    Change in Avoidance Hierarchy
    Description
    A 3 item measure used in our ongoing studies, which assesses how frequently the student avoids specific anxiety provoking situations from 1 = "never" to 7 = "every time."
    Time Frame
    Change from baseline (before intervention) to follow up at 8 months
    Title
    Change in Children's Somatization Inventory (CSI-24)
    Description
    A 24 item measure of the child's somatic symptoms (headaches, stomach aches). Items are ranked using a 5 point scale ranging from "not at all" to "a whole lot."
    Time Frame
    Change from baseline (before intervention) to follow up at 8 months
    Title
    Change in My Memories of Growing Up (Egna Minnen Beträffande Uppfostran; EMBU)
    Description
    A 40 item measure of parental over control and anxious rearing practices associated with higher anxiety. This scale consists of four subscales with 10 items each: overprotection/control, emotional warmth, rejection, and anxious rearing. For purposes of this study, only the overprotection/control and anxious rearing subscales will be used. Items are answered on a 4-point Likert scale ranging from 1= "no," to 4= "yes, most of the time."
    Time Frame
    Change from baseline (before intervention) to follow up at 8 months
    Title
    Change in Family Accommodation Scale - Anxiety (FASA)
    Description
    A measure of accommodation. Parents respond to 9 items, which are coded on a 5-point Likert scale from 0 = "never" to 4 = "daily."
    Time Frame
    Change from baseline (before intervention) to follow up at 8 months
    Title
    Change in Children's Organizational Skills Scale (COSS)
    Description
    A 41 item parent, teacher and child measure of organization, planning and time-management. The COSS yields three subscale scores: task planning, organized actions and memory and materials management.
    Time Frame
    Change from baseline (before intervention) to follow up at 8 months
    Title
    Change in Children's Global Assessment Scale (CGA-S)
    Description
    A measure to assess the student's overall improvement, as a result of participating in the intervention.
    Time Frame
    Change from baseline (before intervention) to follow up at 8 months
    Title
    Change in Strength and Difficulties Questionnaire Parent Version (SDQ
    Description
    A widely used and psychometrically sound (alpha = .80) 25 item parent report questionnaire that assesses emotional and behavioral difficulties in children 4-17 years old. It yields a total score and five subscale scores: emotion problems, conduct problems, hyperactivity, peer problems and prosocial.
    Time Frame
    Change from baseline (before intervention) to follow up at 8 months
    Title
    Change in Revised Child Anxiety and Depression Scale - Depression subscale only (RCADS)
    Description
    The RCADS Depression subscale is comprised of 10 items. Youth respond to items using a 4-point Likert-type scale (0-3) to indicate the frequency of symptoms: 'never,' 'sometimes,' 'often,' and 'always.' Higher scores reflect greater frequency of depressive symptoms.
    Time Frame
    Change from baseline (before intervention) to follow up at 8 months
    Other Pre-specified Outcome Measures:
    Title
    Change in TEAMSS Intervention Satisfaction Questionnaire
    Description
    This measure will be modified from the PI's studies (Ginsburg et al., 2019a).
    Time Frame
    Change from post intervention evaluation to follow up at 8 months
    Title
    Change in The Child and Adolescent Services Assessment (CASA)
    Description
    A 20-item measure assessing the use of general medical health, mental health, social service, and education services. Items are rated on a yes/no scale. The measure includes checkboxes for participants to indicate details about the services (e.g., frequency, indication, provider).
    Time Frame
    Change from baseline (before intervention) to follow up at 8 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    9 Years
    Maximum Age & Unit of Time
    13 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Student: Inclusion Criteria: be in the last year of a participating elementary school have elevated anxiety symptoms that are their primary concern as indicated by 1) a total SCARED score at baseline of 15 or higher using parent and/or child report, and/or 2) a Clinician Severity Rating (CSR) of 3 or higher on the ADIS read and understand English (both parent and child). Exclusion Criteria: Students who have a non-anxiety primary mental health concern (e.g., ADHD) will be excluded from TEAMSS, as this intervention is aimed at reducing anxiety and it would not be effective at treating other mental health concerns. Students with comorbid conditions secondary to anxiety will be eligible. Clinician: Inclusion Criteria: All clinician participants must be at least a part time employee of a CT MS in the role of school clinician. Exclusion Criteria: None
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Golda Ginsburg, PhD
    Phone
    (860) 523-3788
    Email
    gginsburg@uchc.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Kevin Rodriguez, MA
    Phone
    (860) 523-6441
    Email
    kerodriguez@uchc.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Golda Ginsburg, PhD
    Organizational Affiliation
    UConn Health
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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