NCT03132298

Brief Summary

The goal of the project is to test whether a single-session intervention teaching incremental theories of personality, or the belief that one's personality is malleable, can strengthen recovery from social stress and reduce the development of anxiety and depression during early adolescence. Results may suggest a scalable, cost-effective approach to improving youths' coping capacities and preventing adverse mental health outcomes over time.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2015

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

August 17, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 24, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 27, 2017

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

January 23, 2019

Completed
Last Updated

February 7, 2019

Status Verified

January 1, 2019

Enrollment Period

1.2 years

First QC Date

April 24, 2017

Results QC Date

October 2, 2018

Last Update Submit

January 22, 2019

Conditions

Anxiety SymptomsDepressive Symptoms

Outcome Measures

Primary Outcomes (4)

  • Change in Children's Depression Inventory (CDI) From Baseline to 9-month Follow-up

    the Children's Depression Inventory, a 27-item self-report questionnaire that measures cognitive, affective, and behavioral symptoms of depression. Items are scored from 0-2, and scores range from 0 to 44; higher scores indicate greater symptom severity. The CDI is reliable and valid. It can distinguish youths with more or less severe depressive symptoms, as well as youths at risk for depression from non-depressed youths. Suicide- and self-harm related questions were removed for the purposes of this study.

    Baseline and 3-, 6-, and 9-month (final) follow-up

  • Change in Children's Depression Inventory - Parent (CDI-P) From Baseline to 9-month Follow-up

    the Children's Depression Inventory, a 27-item self-report questionnaire that measures cognitive, affective, and behavioral symptoms of depression. Items are scored from 0-2, and scores range from 0 to 44; higher scores indicate greater symptom severity. The CDI and the parent analog (CDI-P) is reliable and valid. It can distinguish youths with more or less severe depressive symptoms, as well as youths at risk for depression from non-depressed youths. Suicide- and self-harm related questions were removed for the purposes of this study.

    Baseline and 3-, 6-, and 9-month (final) follow-up

  • Change in Screen for Child Anxiety Related Disorders - Child (SCARED-C) From Baseline to 9-month Follow-up

    Anxiety symptoms were assessed at baseline and at each follow-up point using the Screen for Child Anxiety and Related Disorders - Child and Parent versions (SCARED-C/SCARED-P). The SCARED-C and SCARED-P are child and parent versions of the same 41-item questionnaire measure of pediatric anxiety. Both differentiate between clinically anxious and nonanxious psychiatrically ill youth. Youths/parents respond to items using a 3-point Likert scale describing the degree to which statements are true about them; scores range from 0 to 82. Internal consistency, test-retest reliability, and construct validity of the SCARED are strong (Hale, Raaijmakers, Muris, \& Meeus, 2005; Myers \& Winters, 2002). In this study, the SCARED-C/P Total Scores were used and derived by summing all 41 items, with higher scores reflecting higher levels of anxiety.

    Baseline and 3-, 6-, and 9-month (final) follow-up

  • Change in Screen for Child Anxiety Related Disorders - Parent (SCARED-P) From Baseline to 9-month Follow-up

    Anxiety symptoms were assessed at baseline and at each follow-up point using the Screen for Child Anxiety and Related Disorders - Child and Parent versions (SCARED-C/SCARED-P). The SCARED-C and SCARED-P are child and parent versions of the same 41-item questionnaire measure of pediatric anxiety. Both differentiate between clinically anxious and nonanxious psychiatrically ill youth. Youths/parents respond to items using a 3-point Likert scale describing the degree to which statements are true about them; scores range from 0 to 82. Internal consistency, test-retest reliability, and construct validity of the SCARED are strong. In this study, the SCARED-C/P Total Scores were used and derived by summing all 41 items, with higher scores reflecting higher levels of anxiety.

    Baseline and 3-, 6-, and 9-month (final) follow-up

Secondary Outcomes (4)

  • Primary Control Scale for Children (PCSC)

    Baseline, immediately post-intervention, and 3-, 6-, and 9-month (final) follow-up

  • Secondary Control Scale for Children (SCSC)

    Baseline, immediately post-intervention, and 3-, 6-, and 9-month (final) follow-up

  • Electrodermal Activity (EDA) Recovery Slope

    Assessed at immediate post-intervention only

  • Heart Rate Variability (HRV) Recovery Slope

    Assessed at immediate post-intervention only

Other Outcomes (4)

  • Beck Depression Inventory

    Baseline and 3-, 6-, and 9-month (final) follow-up

  • Beck Anxiety Inventory

    Baseline and 3-, 6-, and 9-month (final) follow-up

  • Brief Family Assessment Measure

    Baseline and 3-, 6-, and 9-month (final) follow-up

  • +1 more other outcomes

Study Arms (2)

Implicit Theories of Personality Program

EXPERIMENTAL

This program is self-administered, computer-based, and 30 minutes in length. Content is designed to maximize relevance for youths with internalizing distress. The program includes 5 elements: 1. An introduction the concept of neuroplasticity; 2. Testimonials from older youths describing beliefs that people's traits are malleable, given the brain's capacity for change; 3. Further vignettes by older youths describing times when they used "growth mindsets" to cope with peer rejection, hopelessness, and feared embarrassment; 4. A worksheet describing strategies for applying these principles to participants' lives; 5. An exercise wherein participants write notes to younger children, using newly-gleaned information about the malleability of personal traits to help them to cope with setbacks

Other: Implicit Theories of Personality Program

Control Program

ACTIVE COMPARATOR

The Control Program is a computer-based session of supportive therapy (ST), designed to encourage youths to identify and express feelings. ST does not teach specific skills or beliefs and has been shown to be less effective than cognitive-behavioral interventions in reducing youth internalizing distress. Here, ST was designed to control for nonspecific intervention elements (eg. completing an interactive computer program) and to encourage youths to share emotions with others. ST included the same number of reading/writing activities as the experimental program and took the same amount of time (30 mins.) to complete.

Other: Control Program

Interventions

Implicit Theories of Personality ProgramOTHER

This 30-minute, self-administered computer program teaches youths that personality is malleable, as opposed to fixed, due to the human brain's constant potential for change and growth (i.e., neuroplasticity).

Also known as: Growth Mindset of Personality Program
Implicit Theories of Personality Program
Control ProgramOTHER

This 30-minute, self-administered computer program was designed to control for nonspecific aspects of completing a series of computer-based activities in the context of the present study. It was also designed to mimic 'supportive therapy' that youths might receive in usual care settings, stressing the importance of sharing one's feelings with close others.

Also known as: Supportive Therapy (ST) Program
Control Program

Eligibility Criteria

Age12 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Ages 12 to 15 (inclusive) at time of study enrollment
  • One or more of the following (3) criteria, all assessed through an initial parent phone screen: (1) t-score of \>60 (84th percentile) on any disorder subscale of the Revised Child Anxiety and Depression Scale-Parent (RCADS-P, Ebesutani et al., 2010); (2) school-based accommodations for anxiety- or depression-related symptoms, such as through an Individual Education Plan (IEP) or a 504 plan; (3) anxiety and/or depression treatment sought for the youth within the previous 3 years.

You may not qualify if:

  • Psychosis, intellectual disability, pervasive developmental/autism spectrum disorder, and suicidal ideation leading to hospitalization or attempts within the past year.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Harvard University

Cambridge, Massachusetts, 02138, United States

Location

Related Publications (3)

  • 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: 27697671RESULT

  • Schleider JL, Abel MR, Weisz JR. Do Immediate Gains Predict Long-Term Symptom Change? Findings from a Randomized Trial of a Single-Session Intervention for Youth Anxiety and Depression. Child Psychiatry Hum Dev. 2019 Oct;50(5):868-881. doi: 10.1007/s10578-019-00889-2.

    PMID: 30993499DERIVED

  • Schleider J, Weisz J. A single-session growth mindset intervention for adolescent anxiety and depression: 9-month outcomes of a randomized trial. J Child Psychol Psychiatry. 2018 Feb;59(2):160-170. doi: 10.1111/jcpp.12811. Epub 2017 Sep 18.

    PMID: 28921523DERIVED

MeSH Terms

Conditions

Anxiety DisordersDepression

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Results Point of Contact

Title
Jessica Schleider
Organization
Stony Brook University
jessica.schleider@stonybrook.edu
631-632-4131

Study Officials

  • Jessica L Schleider, M.A.

    Harvard University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Participants (N=96), ages 12-15 will be randomized to receive one of two a 30-minute, computer-based programs: (1) a 'growth mindset' program, teaching that personal traits and characteristics are malleable; or (2) a control program, designed to mimic 'supportive therapy,' teaching the value of sharing one's feelings with close others.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD candidate

Study Record Dates

First Submitted

April 24, 2017

First Posted

April 27, 2017

Study Start

August 17, 2015

Primary Completion

October 30, 2016

Study Completion

October 30, 2016

Last Updated

February 7, 2019

Results First Posted

January 23, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will share

IPD sharing plan is consistent with NIH guidelines for sharing participant-level data at the conclusion of the fellowship period.

Locations

US(1)