Clinical trial NCT03132298: Effects of a Single-session Implicit Theories of Personality Intervention on Early Adolescent Psychopathology
Official title: Effects of a Single-session Implicit Theories of Personality Intervention on Recovery From Social Stress and Long-term Psychological Functioning in Early Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety Symptoms
Depressive Symptoms
Lead sponsor: Harvard University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: American Psychological Foundation
First posted: 2017-04-27
Enrollment: 96
Sex: ALL
Minimum age (years): 12
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

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.

Detailed description: Efforts to prevent and reduce mental health problems in youths have advanced greatly in recent years. However, these advances have not reduced rates of youth mental illness on a large scale. Thus, a great need exists for novel, scalable, and low-cost approaches to reducing mental health problems in youth. Ideally, such approaches would be mechanism-targeted: that is, they would act on specific developmental processes that underlie psychological disorders. The proposed research aims to address this need by testing whether a single-session intervention teaching incremental theories of personality, or the belief that one's personality is malleable-as opposed to entity theories of personality, or the belief that one's personality is fixed and unchangeable-can strengthen recovery from social stress and prevent the development of anxiety and depression during early adolescence. Compared to incremental theories, entity theories of personal traits have demonstrated cross-sectional and prospective relations with greater anxiety and depression in youths. Further, a single-session incremental personality theories intervention reduced the development of depressive symptoms in a community sample of adolescents, supporting these theories as powerful intervention and/or prevention targets, even when taught in a brief format. Specifically, this project has two aims. Aim 1 is to evaluate the effect of the implicit theories intervention on two candidate mechanisms of action, or targets, identified by prior research: arousal (measured via physiological reactivity following social stress) and loss (here, perceived loss of behavioral control) in youths 12-15 years of age. Following a lab-based social stress induction, I hypothesize that participants receiving the intervention will recover from stress more rapidly, as indicated by measures of arousal (heart rate variability; electrodermal activity levels) and self-reported loss (increased self-reported perceived control) compared to participants who do not receive the intervention. Aim 2 is to evaluate the effects of the single-session incremental theories intervention on anxiety and depression over a nine-month follow-up period. I will test whether the intervention, compared to a control protocol, reduces symptoms of anxiety an depression the development of anxiety and depression; I will also assess whether this change is a direct result of shifts in the two aforementioned targets (arousal; loss). I predict more positive trajectories in anxiety and depression for youth receiving the intervention, relative to those who do not receive the intervention, across nine months. I will also test whether these trajectories are mediated by changes in the targets described in Aim 1. Finally, regardless of outcomes for Aims 1 and 2, baseline, postintervention, and 9-month measures will be used to map links among implicit theories, interventions targeting those theories, social stress recovery, and youth anxiety and depression over time. Findings may suggest a cost-effective, scalable intervention that improves youth resiliency and mental health.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

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

Primary outcomes:
measure: Change in Children's Depression Inventory (CDI) From Baseline to 9-month Follow-up
timeFrame: Baseline and 3-, 6-, and 9-month (final) follow-up
measure: Change in Children's Depression Inventory - Parent (CDI-P) From Baseline to 9-month Follow-up
timeFrame: Baseline and 3-, 6-, and 9-month (final) follow-up
measure: Change in Screen for Child Anxiety Related Disorders - Child (SCARED-C) From Baseline to 9-month Follow-up
timeFrame: Baseline and 3-, 6-, and 9-month (final) follow-up
measure: Change in Screen for Child Anxiety Related Disorders - Parent (SCARED-P) From Baseline to 9-month Follow-up
timeFrame: Baseline and 3-, 6-, and 9-month (final) follow-up
Secondary outcomes:
measure: Primary Control Scale for Children (PCSC)
timeFrame: Baseline, immediately post-intervention, and 3-, 6-, and 9-month (final) follow-up
measure: Secondary Control Scale for Children (SCSC)
timeFrame: Baseline, immediately post-intervention, and 3-, 6-, and 9-month (final) follow-up
measure: Electrodermal Activity (EDA) Recovery Slope
timeFrame: Assessed at immediate post-intervention only
measure: Heart Rate Variability (HRV) Recovery Slope
timeFrame: Assessed at immediate post-intervention only
Other outcomes:
measure: Beck Depression Inventory
timeFrame: Baseline and 3-, 6-, and 9-month (final) follow-up
measure: Beck Anxiety Inventory
timeFrame: Baseline and 3-, 6-, and 9-month (final) follow-up
measure: Brief Family Assessment Measure
timeFrame: Baseline and 3-, 6-, and 9-month (final) follow-up
measure: Implicit Personality Theory Questionnaire
timeFrame: Baseline, immediately post-intervention, and 3-, 6-, and 9-month follow-up
Locations:
city: Cambridge
country: United States
facility: Harvard University
state: Massachusetts
Study officials:
affiliation: Harvard University
name: Jessica L Schleider, M.A.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.