Depression, AnxietyNCT05493865
Parent-Child Single-Session Growth Mindset Intervention on Adolescent Depression and Anxiety Problems
A study testing The Parent-Child Single-Session-intervention of Mindset Intelligence, Failure and Emotion (PC-SMILE) in people with Depression, Anxiety, run by The Hong Kong Polytechnic University.
Trial 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. Read more about this study
- Who is it for?
- Ages 11 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression, Anxiety
- What is being tested?
- The Parent-Child Single-Session-intervention of Mindset Intelligence, Failure and Emotion (PC-SMILE)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 549 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2024to 31 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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:
Show all 10Show fewer
- 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.
Who cannot join
- 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.
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read more
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.
- Conditions
- Depression, Anxiety
- Being tested
- The Parent-Child Single-Session-intervention of Mindset Intelligence, Failure and Emotion (PC-SMILE)
- Keywords
- implicit theory, fixed mindset, mental health, secondary school students, belief in change
- Medical subject headings
- Depression, Anxiety Disorders, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Parent-Child Single-Session-intervention of Mindset Intelligence, Failure and Emotion (PC-SMILE)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| The Parent-Child Single-Session-intervention of Mindset Intelligence, Failure and Emotion (PC-SMILE) | Experimental | 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. Receives: Behavioral: The Parent-Child Single-Session-intervention of Mindset Intelligence, Failure and Emotion (PC-SMILE) |
| The Child Single-Session-intervention of Mindset Intelligence, Failure and Emotion (C-SMILE) | Experimental | The C-SMILE only provides intervention to children, which has the same components as PC-SMILE. Receives: Behavioral: The Parent-Child Single-Session-intervention of Mindset Intelligence, Failure and Emotion (PC-SMILE) |
| Waitlist control group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Children's depression and anxiety symptoms
25-item Revised Children's Anxiety and Depression Scale (RCADS-25)
Measured: baseline
Children's depression and anxiety symptoms
25-item Revised Children's Anxiety and Depression Scale (RCADS-25)
Measured: two weeks post-intervention
Children's depression and anxiety symptoms
25-item Revised Children's Anxiety and Depression Scale (RCADS-25)
Measured: three months post-intervention
Secondary outcomes (20)
Children's hopelessness
the four-item Hopelessness Scale
Measured: baseline
Children's hopelessness
the four-item Hopelessness Scale
Measured: two weeks post-intervention
Children's hopelessness
the four-item Hopelessness Scale
Measured: three months post-intervention
Children's psychological well-being
the Warwick-Edinburgh Mental Well-Being Scale-7
Measured: baseline
Children's psychological well-being
the Warwick-Edinburgh Mental Well-Being Scale-7
Measured: two weeks post-intervention
Children's psychological well-being
the Warwick-Edinburgh Mental Well-Being Scale-7
Measured: three months post-intervention
Parents' psychological well-being
the Warwick-Edinburgh Mental Well-Being Scale-7
Measured: baseline
Parents' psychological well-being
the Warwick-Edinburgh Mental Well-Being Scale-7
Measured: three months post-intervention
Parent-child relationships
three items
Measured: baseline
Parent-child relationships
three items
Measured: two weeks post-intervention
Parent-child relationships
three items
Measured: three months post-intervention
Parent-child interactions
three questions about how many days the children spend more than 15 minutes per day doing activities with their parents in a week
Measured: baseline
Parent-child interactions
three questions about how many days the children spend more than 15 minutes per day doing activities with their parents in a week
Measured: two weeks post-intervention
Parent-child interactions
three questions about how many days the children spend more than 15 minutes per day doing activities with their parents in a week
Measured: three months post-intervention
Perceived parent learning versus performance orientation
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
Measured: baseline
Perceived parent learning versus performance orientation
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
Measured: two weeks post-intervention
Perceived parent learning versus performance orientation
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
Measured: three months post-intervention
Children's academic self-efficacy
a 5-item scale that was adapted from the part of Patterns of Adaptive Learning Survey
Measured: baseline
Children's academic self-efficacy
a 5-item scale that was adapted from the part of Patterns of Adaptive Learning Survey
Measured: two weeks post-intervention
Children's academic self-efficacy
a 5-item scale that was adapted from the part of Patterns of Adaptive Learning Survey
Measured: three months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2022
- Study start1 Sep 2024 (estimated)
- Primary completion30 Apr 2025 (estimated)
- Study completion31 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Depression, AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 549 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05493865
- Sponsor's protocol ID
- HSEARS20211009001
- Status last verified
- Feb 2024
- First submitted
- 7 Aug 2022
- Last updated
- 12 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhu S, Hu Y, Qi D, Xi A, Chen S, Wang R, Lee P, Wong PWC. Effects of a Digital Parent-Child Single-Session Growth Mindset Intervention on Adolescent Depression and Anxiety Symptoms: A Three-Arm Waitlist Randomized Controlled Trial. Eur J Investig Health Psychol Educ. 2026 Jun 17;16(6):84. doi: 10.3390/ejihpe16060084.
PubMed 42346054
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Parent-Child Single-Session Growth Mindset Intervention on Adolescent Depression and Anxiety Problems: A Three-Arm Waitlist Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05493865
- Acronym / sponsor ID
- HSEARS20211009001
- Conditions
- Depression, Anxiety
- Keywords
- implicit theory, fixed mindset, mental health, secondary school students, belief in change
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 549 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 9 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| The Parent-Child Single-Session-intervention of Mindset Intelligence, Failure and Emotion (PC-SMILE) | Experimental | Behavioral: 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. |
| The Child Single-Session-intervention of Mindset Intelligence, Failure and Emotion (C-SMILE) | Experimental | Behavioral: The Parent-Child Single-Session-intervention of Mindset Intelligence, Failure and Emotion (PC-SMILE)The C-SMILE only provides intervention to children, which has the same components as PC-SMILE. |
| Waitlist control group | No intervention | –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. |
Who may qualify
- Ages
- 11 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- The inclusion criteria for adolescent participants are:
- The inclusion criteria for parent participants are:
Key exclusion criteria (6 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Parent-Child Single-Session-intervention of Mindset Intelligence, Failure and Emotion (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. | Behavioural | The Child Single-Session-intervention of Mindset Intelligence, Failure and Emotion (C-SMILE), The Parent-Child Single-Session-intervention of Mindset Intelligence, Failure and Emotion (PC-SMILE) |
Primary outcome
Children's depression and anxiety symptoms
Time frame: baseline
25-item Revised Children's Anxiety and Depression Scale (RCADS-25)
Children's depression and anxiety symptoms
Time frame: two weeks post-intervention
25-item Revised Children's Anxiety and Depression Scale (RCADS-25)
Children's depression and anxiety symptoms
Time frame: three months post-intervention
25-item Revised Children's Anxiety and Depression Scale (RCADS-25)
20 secondary outcomes
Children's hopelessness
Time frame: baseline
Children's hopelessness
Time frame: two weeks post-intervention
Children's hopelessness
Time frame: three months post-intervention
Children's psychological well-being
Time frame: baseline
Children's psychological well-being
Time frame: two weeks post-intervention
Children's psychological well-being
Time frame: three months post-intervention
Parents' psychological well-being
Time frame: baseline
Parents' psychological well-being
Time frame: three months post-intervention
Parent-child relationships
Time frame: baseline
Parent-child relationships
Time frame: two weeks post-intervention
Parent-child relationships
Time frame: three months post-intervention
Parent-child interactions
Time frame: baseline
Parent-child interactions
Time frame: two weeks post-intervention
Parent-child interactions
Time frame: three months post-intervention
Perceived parent learning versus performance orientation
Time frame: baseline
Perceived parent learning versus performance orientation
Time frame: two weeks post-intervention
Perceived parent learning versus performance orientation
Time frame: three months post-intervention
Children's academic self-efficacy
Time frame: baseline
Children's academic self-efficacy
Time frame: two weeks post-intervention
Children's academic self-efficacy
Time frame: three months post-intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2024.
- Derived from this study: PubMed 42346054Zhu S, Hu Y, Qi D, Xi A, Chen S, Wang R, Lee P, Wong PWC. Effects of a Digital Parent-Child Single-Session Growth Mindset Intervention on Adolescent Depression and Anxiety Symptoms: A Three-Arm Waitlist Randomized Controlled Trial. Eur J Investig Health Psychol Educ. 2026 Jun 17;16(6):84. doi: 10.3390/ejihpe16060084.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing The Parent-Child Single-Session-intervention of Mindset Intelligence, Failure and Emotion (PC-SMILE) in people with Depression, Anxiety, run by The Hong Kong Polytechnic University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shimin Zhu, phD (+85251187809, jasmine.zhu@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Children's depression and anxiety symptoms (time frame: baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05493865, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2024.