Recruiting

Observational Study

Sponsor:

Stony Brook University

Code:

NCT04208425

Conditions

Autism Spectrum Disorder

Eligibility Criteria

Sex: All

Age: 11 - 16

Healthy Volunteers: Not accepted

Interventions

Project Personality

Sharing Feelings Intervention

Study Details

Brief summary:

Interventions for Autism Spectrum Disorder (ASD) are almost uniformly costly and time-intensive, blunting dissemination of intervention and stymying opportunities to make scalable impact. This study offers the first pilot randomized controlled trial (RCT) of whether a single session intervention, shown to reduce internalizing problems in typically-developing youth, may improve core and co-occuring symptoms of ASD.

Conditions

Autism Spectrum Disorder

Study ID

NCT04208425

Start date

Jan 7, 2019

Status verified date

Mar, 2020

Completion date

Mar, 2022

Anticipated

Primary completion date

Dec, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 11 - 16

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Youth between the ages of 11-16 (inclusive) at the time of study participation;
  • Youth with one parent or legal guardian willing to participate in the study (i.e. to be present for the lab visit and to complete questionnaires throughout the study period);
  • Youth speaks English well enough to complete online or virtual based intervention activities;
  • Youth with IQ ≥ 70;
  • Parent or legal guardian speaks English well enough to complete online questionnaires;
  • Youth with SCQ >10;
  • Youth who meet criteria for autism or ASD on the ADOS-2.

Exclusion Criteria:

  • Failure to meet the above inclusion criteria;
  • Intellectual disability (IQ<70), as this may undermine comprehension of intervention materials;
  • Adolescent is non-English speaking;
  • The presence of a known developmental disability aside from ASD that would interfere with study participation;
  • The presence of a significant medical disability or disorder that would interfere with study participation.

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Project Personality

The web-based growth mindset intervention, called Project Personality, is delivered entirely via Qualtrics and takes approximately 30 minutes to complete. All intervention activities are self-administered by youth and delivered in a web-based format, including illustrations and audio-recordings of text. Intervention content is designed to maximize relevance for youths experiencing symptoms of depression, including excessive sadness and hopelessness.

active comparator: Sharing Feelings Intervention

The Sharing Feelings Intervention is delivered entirely via Qualtrics, is self-administered by youth, and takes approximately 30 minutes to complete. It is structurally similar to the growth mindset intervention, but it is designed to mimic supportive therapy (ST). The goals of the ST intervention is to encourage youths to identify and express feelings to close others; the intervention does not teach or emphasize specific skills or beliefs. In previous clinical trials, ST has resulted in significantly fewer reductions in youth internalizing problems compared to cognitive-behavioral and growth mindset interventions.

Interventions

Project Personality

The intervention includes five components: 1. An introduction to the brain, including a lesson on the concept of neuroplasticity, describing how and why our behaviors are controlled by thoughts and feelings in their brains, which have potential for change; 2. Written testimonials from older youths who describe their beliefs that people's personal traits (e.g., sadness, anxiety) are malleable, given the brain's plasticity; 3. Additional vignettes written by older youths, describing times when they used "growth mindsets" to persevere through social and emotional setbacks; 4. A summary of selected scientific studies suggesting that personality can, and often does, change in positive ways over time; and 5. An exercise in which the participants write notes to younger students, drawing on scientific information to describe the malleability of people's personal traits (i.e., a "self-persuasion" exercise).

Sharing Feelings Intervention

The ST SSI is designed to control for nonspecific aspects of intervention, including engagement in a computer program. It includes the same number of reading and writing activities as the web-based growth mindset intervention; it also mirrors the web-based growth mindset intervention as closely as possible, including vignettes written by older youths who describe times when they benefited from sharing their feelings with friends or family.

Primary outcome measure

  • Children's Depression Inventory-2 (CDI-2) [ Time Frame: up to 1 hour Pre-intervention ]
  • Children's Depression Inventory-2 (CDI-2) [ Time Frame: 3-moth followup ]
  • Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2) [ Time Frame: up to 1 hour Pre-intervention ]
  • Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2) [ Time Frame: 3-moth followup ]

Central Contacts and Locations

Central contacts

Locations

Stony Brook University

Recruiting

Stony Brook, New York, United States, 11794

Contacts

Principal Investigator:

Matthew D Lerner, Ph.D

More Information

Sponsor

Stony Brook University

Last update posted

Mar 18, 2020

Last verified

Mar, 2020

Keywords

  • Anxiety
  • Depression
  • Autism
  • Autism Spectrum Disorder
  • Single Session Intervention
  • ASD
  • SSI

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Stony Brook University on 2020-03-18.