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Big Feelings: A Study on Children's Emotions in Therapy

Primary Purpose

Anxiety Disorders, Depressive Disorder, Mood Disorders

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Modular Approach to Therapy for Children with Anxiety, Depression, Trauma or Conduct Problems
Sponsored by
University of Guelph
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety Disorders focused on measuring Child psychotherapy, Emotion regulation, Physiology, Mechanism of change

Eligibility Criteria

8 Years - 15 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Child must be between the ages of 8 and 15 years old and have English proficiency Parents must be over the age of 18 and have English proficiency Must be seeking psychosocial treatment for concerns related to anxiety, depression, or disruptive behaviours Exclusion Criteria: Child has low cognitive functioning that would prevent active participation in research tasks Child reports active suicidality that requiring acute care or hospital intervention Child meets criteria for psychosis, schizophrenia spectrum disorders, eating disorders or autism spectrum disorders Child does not assent to participate in the study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Intervention Arm

    Control Arm

    Arm Description

    Treatment will be administered to participants in this arm.

    No treatment will be administered to participants in this arm until post-test assessment has been completed.

    Outcomes

    Primary Outcome Measures

    Change in parent-rated child psychopathology symptoms
    This outcome will be measured through the Child Behavior Checklist (CBCL), a 113-item measure of child psychopathology symptoms that is completed by parents (parent-report). Parents will rate items on a three-point Likert scale from (0 = Never, 1 = Sometimes, 2 = Often) with scores across syndrome scales (anxious/depressed, withdrawn/depressed, somatic complaints, social problems, thought problems, attention problems, rule-breaking behaviour, and aggressive behaviours) and DSM-oriented scales (affective problems, anxiety problems, somatic problems, attention-deficit/hyperactivity problems, oppositional defiant problems, and conduct problems).
    Change in child self-reported psychopathology symptoms
    This outcome will be measured through the Youth Self Report (YSR) a 112-item measure of child psychopathology symptoms that is completed by children aged 11 - 15 (youth-report). Children will rate items on a three-point Likert scale from (0 = Never, 1 = Sometimes, 2 = Often) with scores across syndrome scales (anxious/depressed, withdrawn/depressed, somatic problems, social problems, thought problems, rule-breaking behaviour, and aggressive behaviours) and DSM-oriented scales (depressive problems, anxiety problems, somatic problems, attention-deficit/hyperactivity problems, oppositional defiant problems, and conduct problems).
    Change in child psychopathology symptoms (past week)
    This outcome will be measured through the Behavior and Feelings Survey (BFS), a 12-item measure of child psychopathology symptoms to be completed by parents (parent-report) and children (youth-report). Parents and children will rate items on a five-point Likert scale from 0 (Not a problem) to 4 (A very big problem) with greater scores (internalizing subscale range = 0-24; externalizing subscale range = 0-24; total score range = 0-48) indicating more severe psychopathology. The BFS generates Internalizing, Externalizing, and Total Problems scores.
    Change in child emotional-behavioural problems
    This outcome will be measured through the Top Problems Assessment (TPA), a brief, clinical interview that is completed by parents (parent-report) and children (youth-report). Children and parents will identify and describe one to three primary issues, rate the severity of each problem on a scale of 0 (not a problem) to 4 (a very big problem). They will then rank order the problems from 1 (biggest problem) to 3 (least big problem).
    Change in child impairment
    This outcome will be measured through the Brief Impairment Scale (BIS), a 23-item measure of child impairment that is completed by one or both parents (parent-report). Parents will rate items on a four-point Likert scale from 0 (No problem) to 3 (A Serious Problem) with greater scores across three domains (interpersonal subscale = 0 - 24, school/work = 0 - 24, self-fulfillment = 0 - 24) indicating more severe impairment.
    Change in ratings of child emotion regulation
    This outcome will be measured through the Negative Emotionality subscale of the Child and Adolescent Dispositions Scale (CADS), a scale of child emotion regulation to be completed by parents (parent-report) and children (youth-report for children). Parents and children will rate the items on a four-point Likert scale from 1 (Not at all) to 4 (Very much/very often) with greater scores (range = 7 - 28) indicating poorer emotion regulation.
    Change in child physiological emotion regulation (heart rate variability)
    This outcome will be measured by child heart rate variability during the completion of lab tasks (Modified Trier Social Stress Test for Children, Piñata Task, Cognitive Reappraisal, Parent-Child Conflict Discussion).
    Change in child physiological emotion regulation (skin conductance)
    This outcome measure will be measured by child skin conductance level during the completion of lab tasks (Modified Trier Social Stress Test for Children, Piñata Task, Cognitive Reappraisal, Parent-Child Conflict Discussion).

    Secondary Outcome Measures

    Change in child psychopathology symptoms on a weekly basis
    This outcome will be measured through the Behavior and Feelings Survey (BFS), a 12-item measure of child psychopathology symptoms to be completed by parents (parent-report) and children (youth-report). Parents and children will rate items on a five-point Likert scale from 0 (Not a problem) to 4 (A very big problem) with greater scores (internalizing subscale range = 0-24; externalizing subscale range = 0-24; total score range = 0-48) indicating more severe psychopathology
    Change in child emotion regulation on a weekly basis
    This outcome will be measured through the Negative Emotionality subscale of the Child and Adolescent Dispositions Scale (CADS), a scale of child emotion regulation to be completed by parents (parent-report) and children (youth-report). Parents and children will rate the items on a four-point Likert scale from 1 (Not at all) to 4 (Very much/very often) with greater scores (range = 7 - 28) indicating poorer emotion regulation.
    Change in parent psychopathology symptoms
    This outcome will be measured through the Brief Symptom Inventory (BSI-18), an 18-item measure of adult psychopathology symptoms to be completed by parents (parent-report). Parents will rate items on a five-item Likert scale from 0 (Not at all) to 4 (Extremely) with greater scores on three dimensions (somatization, depression, anxiety, total score range = 0 - 72) indicating more severe psychopathology.
    Change in parent stress
    This outcome will be measured through the Parenting Stress Index-Short form (PSI-SF), a 36-item of stress in the parent-child relationship. Parents will rate items on a five-point Likert scale from 1 (Strongly Disagree) to 5 (Strongly Agree) with scores categorized into subscales (parental distress, parent-child dysfunctional interaction, and difficult child), and higher scores (range = 0 - 180) indicating greater stress.
    Change in parent emotion regulation
    This outcome will be measured through the Difficulties in Emotion Regulation Scale - Short Form (DERS), an 18-item self-report measure of emotion regulation difficulties to be completed by parents. Parents will indicate the frequency with which they experience difficulties with emotion regulation on a five-point Likert scale from 1 (Almost never) to 5 (Almost always), with greater total scores (range = 18 - 90) indicating greater difficulties with emotion regulation.
    Change in family function
    This outcome will be measured through the Family Functioning Style Scale (FFSS), a 26-item self-report measure of family function to be completed by parents. Parents will rate items on a five-point Likert scale from 0 (Not at all like my family) to 4 (Almost always like my family), with scores categorized into five subscales (interactional patterns, family values, coping strategies, family commitment and resource mobilization) of a family's functioning style
    Change in family organization
    This outcome will be measured using the Confusion, Hubbub, and Order Scale (CHAOS), a 15-item measure of family organization within the home, with 7 items reflecting routine and organization and 8 items reflecting disorganization and commotion. Parents will rate each item as true or false, with scores indicating higher or lower levels of chaos and disorganization.
    Change in parenting
    This outcome will be measured through the Coping with Children's Negative Emotions Scale (CCNES), a 12-item self-report measure of parental emotion parenting practices in response to children's expression of negative emotion. Responses are divided into six subscales representing six distinct types of parental responses. The responses will be grouped in two overall scores: Supportive (Expressive Encouragement, Problem-Focused, and Emotion-Focused Reactions) and Unsupportive (Punitive, Minimizing, and Distress Reactions) practices. Parents will rate the likelihood that they would respond in these distinct ways on a seven-point Likert scale from 1 (Very unlikely) to 7 (Very likely), with greater overall scores (range = 1-7) indicating greater levels of each type of parental response.
    Change in child trauma symptoms
    This outcome will be measured with the Child and Adolescent Trauma Screener (CATS), a 15-item screener of the occurrence of traumatic events, and 25-items of trauma symptoms. Parents will rate items on a four-point Likert scale from 0 (Never) to 3 (Almost always) with greater scores (range = 0 - 75) indicating more severe trauma symptoms.
    Change in child positive and negative affect
    This outcome will be measured with the Positive and Negative Affect Scale (PANAS), a 20-item questionnaire consisting of single-word items describing positive (e.g. excited) and negative (e.g. scared) feelings. Each item is rated on a 5-point scale (1 = Very slightly or not at all; 5 = Extremely).

    Full Information

    First Posted
    November 15, 2022
    Last Updated
    November 23, 2022
    Sponsor
    University of Guelph
    Collaborators
    Centre for Addiction and Mental Health, Canadian Institutes of Health Research (CIHR)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05637320
    Brief Title
    Big Feelings: A Study on Children's Emotions in Therapy
    Official Title
    Biobehavioural Regulation of Negative Emotion as a Transdiagnostic Mechanism of Children's Psychotherapy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 1, 2022 (Anticipated)
    Primary Completion Date
    December 31, 2027 (Anticipated)
    Study Completion Date
    December 31, 2027 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Guelph
    Collaborators
    Centre for Addiction and Mental Health, Canadian Institutes of Health Research (CIHR)

    4. Oversight

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

    5. Study Description

    Brief Summary
    The goal of this clinical trial is to learn about how psychotherapy works for children and adolescents aged 8 - 15 with anxiety, depression, trauma, or disruptive behaviour. The main question it aims to answer is: • Is the biobehavioural regulation of negative emotion a transdiagnostic mechanism of treatment response in psychotherapy for children with anxiety, depression, trauma and/or disruptive behaviour? Children and their parents will be randomly assigned to an evidence-based, transdiagnostic treatment (the Modular Approach to Therapy for Children with Anxiety, Depression, Trauma, and Conduct Problems; MATCH-ADTC) or a waitlist control condition. Participants in both groups will complete a baseline assessment, weekly measures consisting of brief symptom scales and medication tracking, and quarterly assessments every 3 months. Following the intervention/waitlist period, our team will conduct post-test assessments. All assessments, except for the weekly surveys, will consist of symptom scales, clinical interviews, experimental tasks and physiological measures.
    Detailed Description
    Research shows that evidence-based psychotherapies for children's mental health problems are only moderately effective, and as many as 50% of children will fail to respond to treatment or will drop out of treatment. There is thus significant room for improvement. One way to improve outcomes for children and their families is to understand how psychotherapy works for children and to make personalized adjustments to optimize their effectiveness. The primary aim of this study is to test biobehavioural regulation of negative emotion as a transdiagnostic mechanism of treatment response in psychotherapy for children with anxiety, depression, trauma, and/or disruptive behavior. Treatment response will be evaluated as pre-to-post change in symptoms and the rate of symptom change. Biobehavioural regulation of emotion will be measured using a multimodal approach comprising validated parent and child-report questionnaires, performance on behavioral and cognitive regulation tasks, and physiological reactivity. Our second aim is to apply association rule mining, a machine learning technique, to uncover patterns governing variations in regulation components throughout the course of treatment. Patterns will be expressed in the form of data-driven and rule-based algorithms reflecting the relation between emotion regulation and treatment response. Clinicians will be trained on administering the Modular Approach to Therapy for Children with Anxiety, Depression, Trauma, and Conduct Problems (MATCH-ADTC) treatment. Children aged 8 - 15 seeking psychotherapy for anxiety, depression, trauma, or disruptive behaviour will be recruited from two outpatient mental health clinics. Approximately 202 dyads of a child and parent will be recruited for this study. Participants will be randomly assigned to the intervention arm or the waitlist control arm. Participants in both groups will complete a baseline assessment, weekly measures consisting of brief symptom scales and medication tracking, and quarterly assessments every 3 months. Following the intervention/waitlist period, our team will conduct post-test assessments. All assessments, except for the weekly surveys, will consist of symptom scales, clinical interviews, experimental tasks and physiological measures. Participants in the control condition will complete a follow up assessment after their completion of usual care (should they receive usual care), and participants in the intervention condition will complete a follow up assessment 1-year after their completion of treatment.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Anxiety Disorders, Depressive Disorder, Mood Disorders, Conduct Disorder, Oppositional Defiant Disorder, Regulation, Emotion, Child Behavior Disorders, Trauma and Stressor Related Disorders
    Keywords
    Child psychotherapy, Emotion regulation, Physiology, Mechanism of change

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    This study is a randomized controlled trial, consisting of an intervention arm and a control arm, which will occur concurrently. Participants will be continually enrolled in the study until 202 parent-child dyads are recruited.
    Masking
    InvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    404 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention Arm
    Arm Type
    Experimental
    Arm Description
    Treatment will be administered to participants in this arm.
    Arm Title
    Control Arm
    Arm Type
    No Intervention
    Arm Description
    No treatment will be administered to participants in this arm until post-test assessment has been completed.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Modular Approach to Therapy for Children with Anxiety, Depression, Trauma or Conduct Problems
    Other Intervention Name(s)
    MATCH-ADTC
    Intervention Description
    The intervention arm will consist of a transdiagnostic psychotherapy program: The Modular Approach to Therapy for Children with Anxiety, Depression, Trauma, or Conduct Problems (MATCH-ADTC). MATCH draws from various domains of evidence-based treatment and consists of 33 treatment modules. There are several core module sequences for problem areas such as depression, anxiety, trauma, and disruptive behavior, and a clinician can utilize these sequences based on the primary concern of the presenting child. If an individual reports additional stressors or comorbid conditions, the clinician can modify the sequence of the modules to address these comorbidities. MATCH treatment is flexible and is tailored for each individual client.
    Primary Outcome Measure Information:
    Title
    Change in parent-rated child psychopathology symptoms
    Description
    This outcome will be measured through the Child Behavior Checklist (CBCL), a 113-item measure of child psychopathology symptoms that is completed by parents (parent-report). Parents will rate items on a three-point Likert scale from (0 = Never, 1 = Sometimes, 2 = Often) with scores across syndrome scales (anxious/depressed, withdrawn/depressed, somatic complaints, social problems, thought problems, attention problems, rule-breaking behaviour, and aggressive behaviours) and DSM-oriented scales (affective problems, anxiety problems, somatic problems, attention-deficit/hyperactivity problems, oppositional defiant problems, and conduct problems).
    Time Frame
    Change at quarterly (3 month intervals after pre-test), change at post-test (after completion of the waitlist or intervention treatment; an average range 4 - 6 months), change at follow up (1 year after post-test completion)
    Title
    Change in child self-reported psychopathology symptoms
    Description
    This outcome will be measured through the Youth Self Report (YSR) a 112-item measure of child psychopathology symptoms that is completed by children aged 11 - 15 (youth-report). Children will rate items on a three-point Likert scale from (0 = Never, 1 = Sometimes, 2 = Often) with scores across syndrome scales (anxious/depressed, withdrawn/depressed, somatic problems, social problems, thought problems, rule-breaking behaviour, and aggressive behaviours) and DSM-oriented scales (depressive problems, anxiety problems, somatic problems, attention-deficit/hyperactivity problems, oppositional defiant problems, and conduct problems).
    Time Frame
    Change at quarterly (3 month intervals after pre-test), change at post-test (after completion of the waitlist or intervention treatment; an average range 4 - 6 months), change at follow up (1 year after post-test completion)
    Title
    Change in child psychopathology symptoms (past week)
    Description
    This outcome will be measured through the Behavior and Feelings Survey (BFS), a 12-item measure of child psychopathology symptoms to be completed by parents (parent-report) and children (youth-report). Parents and children will rate items on a five-point Likert scale from 0 (Not a problem) to 4 (A very big problem) with greater scores (internalizing subscale range = 0-24; externalizing subscale range = 0-24; total score range = 0-48) indicating more severe psychopathology. The BFS generates Internalizing, Externalizing, and Total Problems scores.
    Time Frame
    Change at post-test (after completion of the waitlist or intervention treatment; an average range 4 - 6 months), change at follow up (1 year after post-test completion)
    Title
    Change in child emotional-behavioural problems
    Description
    This outcome will be measured through the Top Problems Assessment (TPA), a brief, clinical interview that is completed by parents (parent-report) and children (youth-report). Children and parents will identify and describe one to three primary issues, rate the severity of each problem on a scale of 0 (not a problem) to 4 (a very big problem). They will then rank order the problems from 1 (biggest problem) to 3 (least big problem).
    Time Frame
    Change at quarterly (3 month intervals after pre-test), change at post-test (after completion of the waitlist or intervention treatment; an average range 4 - 6 months), change at follow up (1 year after post-test completion)
    Title
    Change in child impairment
    Description
    This outcome will be measured through the Brief Impairment Scale (BIS), a 23-item measure of child impairment that is completed by one or both parents (parent-report). Parents will rate items on a four-point Likert scale from 0 (No problem) to 3 (A Serious Problem) with greater scores across three domains (interpersonal subscale = 0 - 24, school/work = 0 - 24, self-fulfillment = 0 - 24) indicating more severe impairment.
    Time Frame
    Change at post-test (after completion of the waitlist or intervention treatment; an average range 4 - 6 months), change at follow up (1 year after post-test completion)
    Title
    Change in ratings of child emotion regulation
    Description
    This outcome will be measured through the Negative Emotionality subscale of the Child and Adolescent Dispositions Scale (CADS), a scale of child emotion regulation to be completed by parents (parent-report) and children (youth-report for children). Parents and children will rate the items on a four-point Likert scale from 1 (Not at all) to 4 (Very much/very often) with greater scores (range = 7 - 28) indicating poorer emotion regulation.
    Time Frame
    Change at post-test (after completion of the waitlist or intervention treatment; an average range 4 - 6 months), change at follow up (1 year after post-test completion)
    Title
    Change in child physiological emotion regulation (heart rate variability)
    Description
    This outcome will be measured by child heart rate variability during the completion of lab tasks (Modified Trier Social Stress Test for Children, Piñata Task, Cognitive Reappraisal, Parent-Child Conflict Discussion).
    Time Frame
    Change at quarterly (3 month intervals after pre-test), change at post-test (after completion of the waitlist or intervention treatment; an average range 4 - 6 months), change at follow up (1 year after post-test completion)
    Title
    Change in child physiological emotion regulation (skin conductance)
    Description
    This outcome measure will be measured by child skin conductance level during the completion of lab tasks (Modified Trier Social Stress Test for Children, Piñata Task, Cognitive Reappraisal, Parent-Child Conflict Discussion).
    Time Frame
    Change at quarterly (3 month intervals after pre-test), change at post-test (after completion of the waitlist or intervention treatment; an average range 4 - 6 months), change at follow up (1 year after post-test completion)
    Secondary Outcome Measure Information:
    Title
    Change in child psychopathology symptoms on a weekly basis
    Description
    This outcome will be measured through the Behavior and Feelings Survey (BFS), a 12-item measure of child psychopathology symptoms to be completed by parents (parent-report) and children (youth-report). Parents and children will rate items on a five-point Likert scale from 0 (Not a problem) to 4 (A very big problem) with greater scores (internalizing subscale range = 0-24; externalizing subscale range = 0-24; total score range = 0-48) indicating more severe psychopathology
    Time Frame
    From pre-test assessment to post-test assessment, an average of 4 - 6 months
    Title
    Change in child emotion regulation on a weekly basis
    Description
    This outcome will be measured through the Negative Emotionality subscale of the Child and Adolescent Dispositions Scale (CADS), a scale of child emotion regulation to be completed by parents (parent-report) and children (youth-report). Parents and children will rate the items on a four-point Likert scale from 1 (Not at all) to 4 (Very much/very often) with greater scores (range = 7 - 28) indicating poorer emotion regulation.
    Time Frame
    From pre-test assessment to post-test assessment, an average of 4 - 6 months
    Title
    Change in parent psychopathology symptoms
    Description
    This outcome will be measured through the Brief Symptom Inventory (BSI-18), an 18-item measure of adult psychopathology symptoms to be completed by parents (parent-report). Parents will rate items on a five-item Likert scale from 0 (Not at all) to 4 (Extremely) with greater scores on three dimensions (somatization, depression, anxiety, total score range = 0 - 72) indicating more severe psychopathology.
    Time Frame
    Change at post-test (after completion of the waitlist or intervention treatment; an average range 4 - 6 months), change at follow up (1 year after post-test completion)
    Title
    Change in parent stress
    Description
    This outcome will be measured through the Parenting Stress Index-Short form (PSI-SF), a 36-item of stress in the parent-child relationship. Parents will rate items on a five-point Likert scale from 1 (Strongly Disagree) to 5 (Strongly Agree) with scores categorized into subscales (parental distress, parent-child dysfunctional interaction, and difficult child), and higher scores (range = 0 - 180) indicating greater stress.
    Time Frame
    Change at post-test (after completion of the waitlist or intervention treatment; an average range 4 - 6 months), change at follow up (1 year after post-test completion)
    Title
    Change in parent emotion regulation
    Description
    This outcome will be measured through the Difficulties in Emotion Regulation Scale - Short Form (DERS), an 18-item self-report measure of emotion regulation difficulties to be completed by parents. Parents will indicate the frequency with which they experience difficulties with emotion regulation on a five-point Likert scale from 1 (Almost never) to 5 (Almost always), with greater total scores (range = 18 - 90) indicating greater difficulties with emotion regulation.
    Time Frame
    Change at post-test (after completion of the waitlist or intervention treatment; an average range 4 - 6 months), change at follow up (1 year after post-test completion)
    Title
    Change in family function
    Description
    This outcome will be measured through the Family Functioning Style Scale (FFSS), a 26-item self-report measure of family function to be completed by parents. Parents will rate items on a five-point Likert scale from 0 (Not at all like my family) to 4 (Almost always like my family), with scores categorized into five subscales (interactional patterns, family values, coping strategies, family commitment and resource mobilization) of a family's functioning style
    Time Frame
    Change at post-test (after completion of the waitlist or intervention treatment; an average range 4 - 6 months), change at follow up (1 year after post-test completion)
    Title
    Change in family organization
    Description
    This outcome will be measured using the Confusion, Hubbub, and Order Scale (CHAOS), a 15-item measure of family organization within the home, with 7 items reflecting routine and organization and 8 items reflecting disorganization and commotion. Parents will rate each item as true or false, with scores indicating higher or lower levels of chaos and disorganization.
    Time Frame
    Change at post-test (after completion of the waitlist or intervention treatment; an average range 4 - 6 months), change at follow up (1 year after post-test completion)
    Title
    Change in parenting
    Description
    This outcome will be measured through the Coping with Children's Negative Emotions Scale (CCNES), a 12-item self-report measure of parental emotion parenting practices in response to children's expression of negative emotion. Responses are divided into six subscales representing six distinct types of parental responses. The responses will be grouped in two overall scores: Supportive (Expressive Encouragement, Problem-Focused, and Emotion-Focused Reactions) and Unsupportive (Punitive, Minimizing, and Distress Reactions) practices. Parents will rate the likelihood that they would respond in these distinct ways on a seven-point Likert scale from 1 (Very unlikely) to 7 (Very likely), with greater overall scores (range = 1-7) indicating greater levels of each type of parental response.
    Time Frame
    Change at post-test (after completion of the waitlist or intervention treatment; an average range 4 - 6 months), change at follow up (1 year after post-test completion)
    Title
    Change in child trauma symptoms
    Description
    This outcome will be measured with the Child and Adolescent Trauma Screener (CATS), a 15-item screener of the occurrence of traumatic events, and 25-items of trauma symptoms. Parents will rate items on a four-point Likert scale from 0 (Never) to 3 (Almost always) with greater scores (range = 0 - 75) indicating more severe trauma symptoms.
    Time Frame
    Change at post-test (after completion of the waitlist or intervention treatment; an average range 4 - 6 months), change at follow up (1 year after post-test completion)
    Title
    Change in child positive and negative affect
    Description
    This outcome will be measured with the Positive and Negative Affect Scale (PANAS), a 20-item questionnaire consisting of single-word items describing positive (e.g. excited) and negative (e.g. scared) feelings. Each item is rated on a 5-point scale (1 = Very slightly or not at all; 5 = Extremely).
    Time Frame
    Change at post-test (after completion of the waitlist or intervention treatment; an average range 4 - 6 months), change at follow up (1 year after post-test completion)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    8 Years
    Maximum Age & Unit of Time
    15 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Child must be between the ages of 8 and 15 years old and have English proficiency Parents must be over the age of 18 and have English proficiency Must be seeking psychosocial treatment for concerns related to anxiety, depression, or disruptive behaviours Exclusion Criteria: Child has low cognitive functioning that would prevent active participation in research tasks Child reports active suicidality that requiring acute care or hospital intervention Child meets criteria for psychosis, schizophrenia spectrum disorders, eating disorders or autism spectrum disorders Child does not assent to participate in the study
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Cherlyne Wong, BSc
    Phone
    416-535-8501
    Ext
    39142
    Email
    cherlyne.wong@camh.ca
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Kristel Thomassin, PhD
    Organizational Affiliation
    University of Guelph
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
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    Big Feelings: A Study on Children's Emotions in Therapy

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