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Parent-Child Single-Session Growth Mindset Intervention on Adolescent Depression and Anxiety Problems

Primary Purpose

Depression, Anxiety

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
The Parent-Child Single-Session-intervention of Mindset Intelligence, Failure and Emotion (PC-SMILE)
Sponsored by
The Hong Kong Polytechnic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Depression, Anxiety

Eligibility Criteria

11 Years - 16 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • The inclusion criteria for adolescent participants are:

    1. aged between 11-16 (inclusive) with one parent willing to participate;
    2. Chinese youth who can read and write in Chinese;
    3. sufficient visual and auditory abilities to complete the intervention and assessment;
    4. ability to give consent to participate in the study.
  • The inclusion criteria for parent participants are:

    1. living with the child participant;
    2. Chinese-language proficiency and comfort with completing computer-based activities;
    3. sufficient visual and auditory abilities to complete the intervention and assessment;
    4. ownership of personal internet-equipped devices.

Exclusion Criteria:

  • Exclusion criteria for adolescent participants are:

    1. no parental consent;
    2. inability to remain focused to complete the intervention and the survey, which take approximately 45 and 25 minutes respective;
    3. intellectual disability or severe illness or pain that would lead to significant bias in students' health and mental health situation.
  • Exclusion criteria for parent participants are:

    1. having a mental illness;
    2. inability to remain focused to complete the intervention and the survey, which take approximately 45 and 25 minutes respective;
    3. intellectual disability or severe illness or pain that would lead to significant bias in students' health and mental health situation.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    The Parent-Child Single-Session-intervention of Mindset Intelligence, Failure and Emotion (PC-SMILE)

    Waitlist control group

    Arm Description

    The PC-SMILE integrates the growth mindsets of intelligence, failure and negative emotions. The interventions for both students and parents consist of five components: (a) an introduction to brain functions regarding the potential of neuroplasticity and the possibility of changes in intelligence and emotions; (b) stories and testimonials from high-school-aged youths who describe their beliefs-in-change; (c) short videos with stories of improving intelligence and emotions and of failure-is-enhancing; (d) common questions and misconceptions about growth mindset; and (e) self-persuasion writing exercises in which the participants write notes to young students/others about the growth mindsets. The interventions for parents and students are different in terms of narrative and content. A total of 10 weekly booster messages with core intervention content will be sent to the intervention group between the two-week post-test and the three-month follow-up survey.

    The waitlist control group will continue with normal education activities and do the pre- and post- intervention surveys at the same timeframe as the intervention group. Participants in waitlist group will be invited to complete the PC-SMILE after the three-month post-intervention survey.

    Outcomes

    Primary Outcome Measures

    Children's depression and anxiety symptoms
    25-item Revised Children's Anxiety and Depression Scale (RCADS-25)
    Children's depression and anxiety symptoms
    25-item Revised Children's Anxiety and Depression Scale (RCADS-25)
    Children's depression and anxiety symptoms
    25-item Revised Children's Anxiety and Depression Scale (RCADS-25)
    Parental anxiety
    the anxious rearing subscale of the Egna Minnen Betraffande Uppfostran Scale (EMBU)
    Parental anxiety
    the anxious rearing subscale of the Egna Minnen Betraffande Uppfostran Scale (EMBU)
    Parental anxiety
    the anxious rearing subscale of the Egna Minnen Betraffande Uppfostran Scale (EMBU)

    Secondary Outcome Measures

    Children's perceived control
    the four-item Emotion Control subscale of the Anxiety Control Questionnaire
    Children's perceived control
    the four-item Emotion Control subscale of the Anxiety Control Questionnaire
    Children's hopelessness
    the four-item Hopelessness Scale
    Children's hopelessness
    the four-item Hopelessness Scale
    Children's attitude towards seeking help
    it will be measured by a single-item scale
    Children's attitude towards seeking help
    it will be measured by a single-item scale
    Children's psychological well-being
    the Warwick-Edinburgh Mental Well-Being Scale
    Children's psychological well-being
    the Warwick-Edinburgh Mental Well-Being Scale
    Parents' psychological well-being
    the Warwick-Edinburgh Mental Well-Being Scale
    Parents' psychological well-being
    the Warwick-Edinburgh Mental Well-Being Scale
    Parent-child relationships
    the cohesion subscale of the Family Adaptation and Cohesion Evaluation Scales II - Chinese Version
    Parent-child relationships
    the cohesion subscale of the Family Adaptation and Cohesion Evaluation Scales II - Chinese Version

    Full Information

    First Posted
    August 7, 2022
    Last Updated
    August 7, 2022
    Sponsor
    The Hong Kong Polytechnic University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05493865
    Brief Title
    Parent-Child Single-Session Growth Mindset Intervention on Adolescent Depression and Anxiety Problems
    Official Title
    Effects of Parent-Child Single-Session Growth Mindset Intervention on Adolescent Depression and Anxiety Problems: A Two-Arm Waitlist Randomised Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 1, 2023 (Anticipated)
    Primary Completion Date
    December 31, 2024 (Anticipated)
    Study Completion Date
    December 31, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    The Hong Kong Polytechnic University

    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
    Depression and anxiety are common mental health problems among adolescents worldwide. In Hong Kong, one in every four secondary school students reports clinical-level depression or anxiety symptoms. Extant research has found that a fixed mindset on intelligence and emotions and failure-is-debilitating belief are closely related to more depression and anxiety symptoms, hopelessness and suicidality. At the same time, recent research also points to the importance of parental mindset. Parents are the primary social support of adolescents; parental belief systems can strongly influence children's affect, behaviour and mental health. However, the effects of parent-child mindset interventions on a child's internalising problems have not yet been empirically examined. As emerging evidence has shown the promise of single-session interventions on reducing and preventing youth internalising problems, this project develops and examines a parent and child single-session intervention on mindsets of intelligence, failure and emotion (PC-SMILE) - to tackle depression and anxiety in young people and promote parental well-being. Using a two-arm randomised controlled trial, the proposed study will examine the effectiveness of PC-SMILE on reducing depression and anxiety symptoms among children, reducing parental anxiety, enhancing perceived control and parent-child relationships. A total of 366 parent-child dyads will be recruited from eight secondary schools and randomly assigned to either the PC-SMILE intervention group or the no-intervention waitlist control group. The PC-SMILE is approximately 45 minutes in length. Parent and child mental health and family relationship will be assessed at three time points: baseline before intervention (T1), within two weeks post-intervention (T2) and three months post-intervention (T3). A pilot test (n = 9) has supported the feasibility and acceptability of the PC-SMILE intervention. We hypothesise that the PC-SMILE intervention will significantly improve child depression and anxiety and parent anxiety (primary outcome) and significantly improve secondary outcomes, including child perceived control over emotion, children's and parents' hopelessness, psychological wellbeing, and parent-child relationships. The intention-to-treat principle and linear-regression-based maximum likelihood multi-level models will be used for data analysis. The project brings together experts in mindset research, family therapy, statistics, youth depression, and psychiatry. The Principal Investigator's strong connection with schools ensures the feasibility of the study. This study will not only provide evidence on parent-child growth mindset intervention for adolescent internalising problems but can also serve as a scalable and accessible intervention for improving the well-being of young people and their parents.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Depression, Anxiety

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Masking Description
    Due to the nature of intervention, blinding participants to the allocation is impossible. But Before the intervention starts, participants have no knowledge on which group they are belonging to.
    Allocation
    Randomized
    Enrollment
    366 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    The Parent-Child Single-Session-intervention of Mindset Intelligence, Failure and Emotion (PC-SMILE)
    Arm Type
    Experimental
    Arm Description
    The PC-SMILE integrates the growth mindsets of intelligence, failure and negative emotions. The interventions for both students and parents consist of five components: (a) an introduction to brain functions regarding the potential of neuroplasticity and the possibility of changes in intelligence and emotions; (b) stories and testimonials from high-school-aged youths who describe their beliefs-in-change; (c) short videos with stories of improving intelligence and emotions and of failure-is-enhancing; (d) common questions and misconceptions about growth mindset; and (e) self-persuasion writing exercises in which the participants write notes to young students/others about the growth mindsets. The interventions for parents and students are different in terms of narrative and content. A total of 10 weekly booster messages with core intervention content will be sent to the intervention group between the two-week post-test and the three-month follow-up survey.
    Arm Title
    Waitlist control group
    Arm Type
    No Intervention
    Arm Description
    The waitlist control group will continue with normal education activities and do the pre- and post- intervention surveys at the same timeframe as the intervention group. Participants in waitlist group will be invited to complete the PC-SMILE after the three-month post-intervention survey.
    Intervention Type
    Behavioral
    Intervention Name(s)
    The Parent-Child Single-Session-intervention of Mindset Intelligence, Failure and Emotion (PC-SMILE)
    Intervention Description
    This study will be a two-arm cluster-randomised controlled trial to examine the efficacy of the PC-SMILE for adolescents and their parents by comparing to a no-intervention waitlist control group.
    Primary Outcome Measure Information:
    Title
    Children's depression and anxiety symptoms
    Description
    25-item Revised Children's Anxiety and Depression Scale (RCADS-25)
    Time Frame
    baseline
    Title
    Children's depression and anxiety symptoms
    Description
    25-item Revised Children's Anxiety and Depression Scale (RCADS-25)
    Time Frame
    two weeks post-intervention
    Title
    Children's depression and anxiety symptoms
    Description
    25-item Revised Children's Anxiety and Depression Scale (RCADS-25)
    Time Frame
    three months post-intervention
    Title
    Parental anxiety
    Description
    the anxious rearing subscale of the Egna Minnen Betraffande Uppfostran Scale (EMBU)
    Time Frame
    baseline
    Title
    Parental anxiety
    Description
    the anxious rearing subscale of the Egna Minnen Betraffande Uppfostran Scale (EMBU)
    Time Frame
    two weeks post-intervention
    Title
    Parental anxiety
    Description
    the anxious rearing subscale of the Egna Minnen Betraffande Uppfostran Scale (EMBU)
    Time Frame
    three months post-intervention
    Secondary Outcome Measure Information:
    Title
    Children's perceived control
    Description
    the four-item Emotion Control subscale of the Anxiety Control Questionnaire
    Time Frame
    baseline
    Title
    Children's perceived control
    Description
    the four-item Emotion Control subscale of the Anxiety Control Questionnaire
    Time Frame
    three months post-intervention
    Title
    Children's hopelessness
    Description
    the four-item Hopelessness Scale
    Time Frame
    baseline
    Title
    Children's hopelessness
    Description
    the four-item Hopelessness Scale
    Time Frame
    three months post-intervention
    Title
    Children's attitude towards seeking help
    Description
    it will be measured by a single-item scale
    Time Frame
    baseline
    Title
    Children's attitude towards seeking help
    Description
    it will be measured by a single-item scale
    Time Frame
    three months post-intervention
    Title
    Children's psychological well-being
    Description
    the Warwick-Edinburgh Mental Well-Being Scale
    Time Frame
    baseline
    Title
    Children's psychological well-being
    Description
    the Warwick-Edinburgh Mental Well-Being Scale
    Time Frame
    three months post-intervention
    Title
    Parents' psychological well-being
    Description
    the Warwick-Edinburgh Mental Well-Being Scale
    Time Frame
    baseline
    Title
    Parents' psychological well-being
    Description
    the Warwick-Edinburgh Mental Well-Being Scale
    Time Frame
    three months post-intervention
    Title
    Parent-child relationships
    Description
    the cohesion subscale of the Family Adaptation and Cohesion Evaluation Scales II - Chinese Version
    Time Frame
    baseline
    Title
    Parent-child relationships
    Description
    the cohesion subscale of the Family Adaptation and Cohesion Evaluation Scales II - Chinese Version
    Time Frame
    three months post-intervention

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    11 Years
    Maximum Age & Unit of Time
    16 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: The inclusion criteria for adolescent participants are: aged between 11-16 (inclusive) with one parent willing to participate; Chinese youth who can read and write in Chinese; sufficient visual and auditory abilities to complete the intervention and assessment; ability to give consent to participate in the study. The inclusion criteria for parent participants are: living with the child participant; Chinese-language proficiency and comfort with completing computer-based activities; sufficient visual and auditory abilities to complete the intervention and assessment; ownership of personal internet-equipped devices. Exclusion Criteria: Exclusion criteria for adolescent participants are: no parental consent; inability to remain focused to complete the intervention and the survey, which take approximately 45 and 25 minutes respective; intellectual disability or severe illness or pain that would lead to significant bias in students' health and mental health situation. Exclusion criteria for parent participants are: having a mental illness; inability to remain focused to complete the intervention and the survey, which take approximately 45 and 25 minutes respective; intellectual disability or severe illness or pain that would lead to significant bias in students' health and mental health situation.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Shimin Zhu, phD
    Phone
    +85251187809
    Email
    jasmine.zhu@polyu.edu.hk

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Parent-Child Single-Session Growth Mindset Intervention on Adolescent Depression and Anxiety Problems

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