A Single-session Growth Mindset Intervention for Children and Young People With Mental Health Difficulties

NCT04652362 | Suspended

• 1 other identifier: 2243
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The present study aims to evaluate whether an online, self-administered, single session intervention (SSI) increases children and adolescents' perceptions of control over external threats and their emotional experience and reduces self-reported symptoms of anxiety and low mood. Children and adolescents, identified by their parents as having difficulties with low mood or anxiety, will be randomised to receive either the growth mindset of personality intervention or an active comparison condition. Whether parental low mood and anxiety has a moderating impact on outcomes will also be investigated.

Conditions

Anxiety; Anxiety Disorders; Depression; Low Mood

Keywords

controlled clinical trials; internet-based intervention

Outcome Measures

Primary Outcomes (2)

• Change in Perceived Primary Control Scale for Children; Youth-Report

  The Perceived Primary Control Scale for Children (Weisz, Southam-Gerow, \& McCarty, 2001; Weisz, Weiss, Wasserman, \& Rintoul, 1987) measures young people's perceived ability to exert control over situations or events by exerting personal effort. The measure includes 24 statements relating to primary control (e.g. "I can make friends with other kids if I really try" or "I cannot get good grades no matter how hard I try") and respondents are required to rate their agreement with the statement on a Likert scale with responses ranging from "very false" to "very true".

  Immediately pre and post intervention

• Change in Perceived Secondary Control Scale for Children; Youth-Report

  The Perceived Secondary Control Scale for Children (Weisz, Francis, \& Bearman, 2010) measures young people's perceived ability to control the psychological impact of situations or events through the use of cognitive and behavioural strategies. Participants are required to rate their degree of agreement (on the same scale as the PCSC) to 20 statements regarding secondary control (e.g. "When something bad happens, I can find a way to think about it that makes me feel better" or "When something bad happens, I keep worrying about how bad it is").

  Immediately pre and post intervention

Secondary Outcomes (2)

• Change in Implicit Theories of Personality Questionnaire; Youth-Report

  Immediately pre and post intervention

• Change in Pediatric Quality of Life Inventory (PEDS-QL) Present Functioning Visual Analogue Scales

  Immediately pre and post intervention

Other Outcomes (4)

• Revised Children's Anxiety and Depression Scale (RCADS); Parent-Report

  Completed by parents pre-intervention

• Patient Health Questionnaire (PHQ-9)

  Completed by parents pre-intervention

• Generalized Anxiety Disorders Scale (GAD 7)

  Completed by parents pre-intervention

Study Arms (2)

Growth Mindset Intervention

EXPERIMENTAL

Behavioral: Growth Mindset Online Single-Session Intervention

Supportive Therapy Intervention

ACTIVE COMPARATOR

Behavioral: Supportive Therapy Online Single-Session Intervention (Control)

Interventions

Growth Mindset Online Single-Session Intervention BEHAVIORAL

During the self-administered single session intervention participants are provided with basic information about the brain and are introduced to the concept of neuroplasticity. The concept of neuroplasticity is applied to personal traits, such as shyness, anxiety and sadness, and young people are taught that these traits are the result of thoughts and feelings in our brain and are amenable to change. Participants are presented with scientific information and research evidence to support the idea that people have the potential to change and are given vignettes from older children detailing how they have used a growth mindset to overcome difficulties. The intervention takes approximately 20-30 minutes to complete.

Growth Mindset Intervention

Supportive Therapy Online Single-Session Intervention (Control) BEHAVIORAL

The single session supportive therapy intervention was designed to be structurally comparable to the growth mindset intervention, including the same number of reading and writing activities. Participants were provided with information about emotions and the benefits of expressing emotions. Vignettes from older children described times they had shared their emotions with friends and family members.

Supportive Therapy Intervention

Eligibility Criteria

• Age: 8 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Young person aged between the ages of 8 and 16 years-old
• Young person has difficulties with low mood or anxiety as identified by a parent or caregiver
• Young person has a parent or caregiver willing to take part in the research
• Both the young person and parent must be able to read and understand English to a level enabling them to access the assessment and intervention

You may not qualify if:

• \- None

Sponsors & Collaborators

• Royal Holloway University: lead

Study Sites (1)

Royal Holloway, University of London

London, TW20 0EX, United Kingdom

Location

Related Publications (1)

• Schleider JL, Weisz JR. Reducing risk for anxiety and depression in adolescents: Effects of a single-session intervention teaching that personality can change. Behav Res Ther. 2016 Dec;87:170-181. doi: 10.1016/j.brat.2016.09.011. Epub 2016 Sep 26.

  PMID: 27697671 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders; Depression; Consciousness Disorders

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders

Study Officials

• Harriet Clarkson

  Royal Holloway University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants will not be informed about the contents of the two different programmes and therefore will be blind to group allocation. Randomisation, questionnaire and intervention delivery will be fully automated through the Qualtrics platform and therefore researchers will also be blind to group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Trainee Clinical Psychologist

Model Details: Participants will be randomly allocated to either the growth mindset intervention or the supportive therapy control condition.

Study Record Dates

• First Submitted: November 26, 2020
• First Posted: December 3, 2020
• Study Start: November 10, 2020
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: May 12, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)