NCT05493865

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 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
549

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2024

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 7, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 9, 2022

Completed
2.1 years until next milestone

Study Start

First participant enrolled

September 1, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2025

Completed
Last Updated

June 12, 2024

Status Verified

February 1, 2024

Enrollment Period

8 months

First QC Date

August 7, 2022

Last Update Submit

June 10, 2024

Conditions

Keywords

implicit theory, fixed mindset, mental health, secondary school students, belief in change

Outcome Measures

Primary Outcomes (3)

  • Children's depression and anxiety symptoms

    25-item Revised Children's Anxiety and Depression Scale (RCADS-25)

    baseline

  • Children's depression and anxiety symptoms

    25-item Revised Children's Anxiety and Depression Scale (RCADS-25)

    two weeks post-intervention

  • Children's depression and anxiety symptoms

    25-item Revised Children's Anxiety and Depression Scale (RCADS-25)

    three months post-intervention

Secondary Outcomes (20)

  • Children's hopelessness

    baseline

  • Children's hopelessness

    two weeks post-intervention

  • Children's hopelessness

    three months post-intervention

  • Children's psychological well-being

    baseline

  • Children's psychological well-being

    two weeks post-intervention

  • +15 more secondary outcomes

Study Arms (3)

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.

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.

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.

Interventions

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.

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)

Eligibility Criteria

Age11 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

DepressionAnxiety DisordersPsychological Well-Being

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental DisordersPersonal Satisfaction

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
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.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 7, 2022

First Posted

August 9, 2022

Study Start

September 1, 2024

Primary Completion

April 30, 2025

Study Completion

October 31, 2025

Last Updated

June 12, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share