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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05493865
Other study ID # HSEARS20211009001
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date September 1, 2024
Est. completion date October 31, 2025

Study information

Verified date February 2024
Source The Hong Kong Polytechnic University
Contact Shimin Zhu, phD
Phone +85251187809
Email jasmine.zhu@polyu.edu.hk
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 549
Est. completion date October 31, 2025
Est. primary completion date April 30, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 11 Years to 16 Years
Eligibility 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.

Study Design


Intervention

Behavioral:
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
The Hong Kong Polytechnic University

Outcome

Type Measure Description Time frame Safety issue
Primary Children's depression and anxiety symptoms 25-item Revised Children's Anxiety and Depression Scale (RCADS-25) baseline
Primary Children's depression and anxiety symptoms 25-item Revised Children's Anxiety and Depression Scale (RCADS-25) two weeks post-intervention
Primary Children's depression and anxiety symptoms 25-item Revised Children's Anxiety and Depression Scale (RCADS-25) three months post-intervention
Secondary Children's hopelessness the four-item Hopelessness Scale baseline
Secondary Children's hopelessness the four-item Hopelessness Scale two weeks post-intervention
Secondary Children's hopelessness the four-item Hopelessness Scale three months post-intervention
Secondary Children's psychological well-being the Warwick-Edinburgh Mental Well-Being Scale-7 baseline
Secondary Children's psychological well-being the Warwick-Edinburgh Mental Well-Being Scale-7 two weeks post-intervention
Secondary Children's psychological well-being the Warwick-Edinburgh Mental Well-Being Scale-7 three months post-intervention
Secondary Parents' psychological well-being the Warwick-Edinburgh Mental Well-Being Scale-7 baseline
Secondary Parents' psychological well-being the Warwick-Edinburgh Mental Well-Being Scale-7 three months post-intervention
Secondary Parent-child relationships three items baseline
Secondary Parent-child relationships three items two weeks post-intervention
Secondary Parent-child relationships three items three months post-intervention
Secondary 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 baseline
Secondary 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 two weeks post-intervention
Secondary 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 three months post-intervention
Secondary 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 baseline
Secondary 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 two weeks post-intervention
Secondary 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 three months post-intervention
Secondary Children's academic self-efficacy a 5-item scale that was adapted from the part of Patterns of Adaptive Learning Survey baseline
Secondary Children's academic self-efficacy a 5-item scale that was adapted from the part of Patterns of Adaptive Learning Survey two weeks post-intervention
Secondary Children's academic self-efficacy a 5-item scale that was adapted from the part of Patterns of Adaptive Learning Survey three months post-intervention
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