- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05493865
Parent-Child Single-Session Growth Mindset Intervention on Adolescent Depression and Anxiety Problems
Effects of Parent-Child Single-Session Growth Mindset Intervention on Adolescent Depression and Anxiety Problems: A Three-Arm Waitlist Randomised Controlled Trial
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 in 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 three-arm randomised controlled trial, the proposed study will examine the effectiveness of PC-SMILE on reducing depression and anxiety symptoms among children, enhancing well-being and parent-child relationships.
A total of 549 parent-child dyads will be recruited from six secondary schools and randomly assigned to either the PC-SMILE intervention group, the C-SMILE intervention group, or the no-intervention waitlist control group. The intervention is approximately 45 minutes in length. In the PC-SMILE group, both parent and child will receive intervention, and their 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). In the C-SMILE group, only the child will undergo intervention, while both the child and parent will be required to complete the repeated assessments. A pilot test (n = 9) has supported the feasibility and acceptability of the PC-SMILE intervention. We hypothesise that compared to the waitlist control group, the PC-SMILE intervention group and C-SMILE group will significantly improve child depression and anxiety (primary outcome) and significantly improve secondary outcomes, including children's academic self-efficacy, hopelessness, psychological well-being, and parent-child interactions and relationships, and PC-SMILE group is more effective than C-SMILE group. The intention-to-treat principle and linear-regression-based maximum likelihood multi-level models will be used for data analysis.
As of May 2024, we enrolled 75 students and their parents in 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.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Shimin Zhu, phD
- Phone Number: +85251187809
- Email: jasmine.zhu@polyu.edu.hk
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: The Parent-Child Single-Session-intervention of Mindset Intelligence, Failure and Emotion (PC-SMILE)
The PC-SMILE integrates the growth mindsets of intelligence, failure, and negative emotions and introduces these growth mindsets to students and parents, which 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 between the two-week post-test and the three-month follow-up survey.
|
This study will be a three-arm cluster-randomised controlled trial to examine the efficacy of the PC-SMILE for adolescents by comparing to a C-SMILE intervention group and a no-intervention waitlist control group.
|
|
Experimental: The Child Single-Session-intervention of Mindset Intelligence, Failure and Emotion (C-SMILE)
The C-SMILE only provides intervention to children, which has the same components as PC-SMILE.
|
This study will be a three-arm cluster-randomised controlled trial to examine the efficacy of the PC-SMILE for adolescents by comparing to a C-SMILE intervention group and a no-intervention waitlist control group.
|
|
No Intervention: Waitlist control group
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 groups.
Participants in the waitlist group and C-SMILE group will be invited to complete the PC-SMILE after the three-month post-intervention survey.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Children's depression and anxiety symptoms
Time Frame: baseline
|
25-item Revised Children's Anxiety and Depression Scale (RCADS-25)
|
baseline
|
|
Children's depression and anxiety symptoms
Time Frame: two weeks post-intervention
|
25-item Revised Children's Anxiety and Depression Scale (RCADS-25)
|
two weeks post-intervention
|
|
Children's depression and anxiety symptoms
Time Frame: three months post-intervention
|
25-item Revised Children's Anxiety and Depression Scale (RCADS-25)
|
three months post-intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Children's hopelessness
Time Frame: baseline
|
the four-item Hopelessness Scale
|
baseline
|
|
Children's hopelessness
Time Frame: three months post-intervention
|
the four-item Hopelessness Scale
|
three months post-intervention
|
|
Children's hopelessness
Time Frame: two weeks post-intervention
|
the four-item Hopelessness Scale
|
two weeks post-intervention
|
|
Children's psychological well-being
Time Frame: baseline
|
the Warwick-Edinburgh Mental Well-Being Scale-7
|
baseline
|
|
Children's psychological well-being
Time Frame: two weeks post-intervention
|
the Warwick-Edinburgh Mental Well-Being Scale-7
|
two weeks post-intervention
|
|
Children's psychological well-being
Time Frame: three months post-intervention
|
the Warwick-Edinburgh Mental Well-Being Scale-7
|
three months post-intervention
|
|
Parents' psychological well-being
Time Frame: baseline
|
the Warwick-Edinburgh Mental Well-Being Scale-7
|
baseline
|
|
Parents' psychological well-being
Time Frame: three months post-intervention
|
the Warwick-Edinburgh Mental Well-Being Scale-7
|
three months post-intervention
|
|
Parent-child relationships
Time Frame: baseline
|
three items
|
baseline
|
|
Parent-child relationships
Time Frame: two weeks post-intervention
|
three items
|
two weeks post-intervention
|
|
Parent-child relationships
Time Frame: three months post-intervention
|
three items
|
three months post-intervention
|
|
Parent-child interactions
Time Frame: baseline
|
three questions about how many days the children spend more than 15 minutes per day doing activities with their parents in a week
|
baseline
|
|
Parent-child interactions
Time Frame: two weeks post-intervention
|
three questions about how many days the children spend more than 15 minutes per day doing activities with their parents in a week
|
two weeks post-intervention
|
|
Parent-child interactions
Time Frame: three months post-intervention
|
three questions about how many days the children spend more than 15 minutes per day doing activities with their parents in a week
|
three months post-intervention
|
|
Perceived parent learning versus performance orientation
Time Frame: baseline
|
8 items for children and 12 items for parents to indicate the extent to which reactions parents would have and which reactions children would perceive
|
baseline
|
|
Perceived parent learning versus performance orientation
Time Frame: two weeks post-intervention
|
8 items for children and 12 items for parents to indicate the extent to which reactions parents would have and which reactions children would perceive
|
two weeks post-intervention
|
|
Perceived parent learning versus performance orientation
Time Frame: three months post-intervention
|
8 items for children and 12 items for parents to indicate the extent to which reactions parents would have and which reactions children would perceive
|
three months post-intervention
|
|
Children's academic self-efficacy
Time Frame: baseline
|
a 5-item scale that was adapted from the part of Patterns of Adaptive Learning Survey
|
baseline
|
|
Children's academic self-efficacy
Time Frame: two weeks post-intervention
|
a 5-item scale that was adapted from the part of Patterns of Adaptive Learning Survey
|
two weeks post-intervention
|
|
Children's academic self-efficacy
Time Frame: three months post-intervention
|
a 5-item scale that was adapted from the part of Patterns of Adaptive Learning Survey
|
three months post-intervention
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HSEARS20211009001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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