Promoting Resilience in Teens With ASD

NCT04208425 | Unknown

• 3 other identifiers: IRB2019-00280AWD00001042AWD00001244
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (4)

• Children's Depression Inventory-2 (CDI-2)

  Adolescent depressive symptom severity will be assessed using the Children's Depression Inventory-2 (CDI-2) Child and Parent forms. The CDI-2 is a reliable, valid measure of youth depression severity, normed for youth age and sex and yielding raw and T scores. Changes in youth CDI2 scores from baseline to each of the follow-up assessments will serve as the primary index of intervention effects. The CDI-2 will take approximately 15 minutes to complete. Each item on the child form is scored 0-2, yielding a total score between 0 and 56 with a higher total score indicating increased depressive symptomatology and a lower total score indicating decreased depressive symptomatology. Each item on the parent form is scored 0-3, yielding a total score between 0 and 51 with a higher score indicating increased depressive symptomatology and a lower total score indicating decreased depressive symptomatology.

  up to 1 hour Pre-intervention

• Children's Depression Inventory-2 (CDI-2)

  Adolescent depressive symptom severity will be assessed using the Children's Depression Inventory-2 (CDI-2) Child and Parent forms. The CDI-2 is a reliable, valid measure of youth depression severity, normed for youth age and sex and yielding raw and T scores. Changes in youth CDI2 scores from baseline to each of the follow-up assessments will serve as the primary index of intervention effects. The CDI-2 will take approximately 15 minutes to complete. Each item on the child form is scored 0-2, yielding a total score between 0 and 56 with a higher total score indicating increased depressive symptomatology and a lower total score indicating decreased depressive symptomatology. Each item on the parent form is scored 0-3, yielding a total score between 0 and 51 with a higher score indicating increased depressive symptomatology and a lower total score indicating decreased depressive symptomatology.

  3-moth followup

• Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2)

  The Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2) is a valid, reliable tool for assessing executive functioning skills in home and school environments. Changes in BRIEF-2 scores from baseline to the 3-month follow-up assessment will serve as the primary index of intervention effects. The BRIEF-2 will take approximately 10 minutes. Each item on the child form is scored 1-3 (1 = Never; 2 = Sometimes; 3 = Often), yielding a total score between 55 and 165 with a higher total score indicating more severe deficiency. Each item on the parent form is scored 1-3 (1 = Never; 2 = Sometimes; 3 = Often), yielding a total scored between 55 and 165 with a higher total score indicating more severe deficiency.

  up to 1 hour Pre-intervention

• Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2)

  The Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2) is a valid, reliable tool for assessing executive functioning skills in home and school environments. Changes in BRIEF-2 scores from baseline to the 3-month follow-up assessment will serve as the primary index of intervention effects. The BRIEF-2 will take approximately 10 minutes. Each item on the child form is scored 1-3 (1 = Never; 2 = Sometimes; 3 = Often), yielding a total score between 55 and 165 with a higher total score indicating more severe deficiency. Each item on the parent form is scored 1-3 (1 = Never; 2 = Sometimes; 3 = Often), yielding a total scored between 55 and 165 with a higher total score indicating more severe deficiency.

  3-moth followup

Secondary Outcomes (18)

• Brief Symptom Inventory 18 (BSI-18)

  up to 1 hour Pre-intervention

• Brief Symptom Inventory 18 (BSI-18)

  3-month followup

• Multidimensional Anxiety Scale for Children-2 (MASC-2)

  up to 1 hour Pre-intervention

• Multidimensional Anxiety Scale for Children-2 (MASC-2)

  3-month followup

• Primary Control Scale for Children (PCSC)

  up to 1 hour Pre-intervention

Study Arms (2)

Project Personality

EXPERIMENTAL

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.

Behavioral: Project Personality

Sharing Feelings Intervention

ACTIVE COMPARATOR

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.

Behavioral: Sharing Feelings Intervention

Interventions

Project Personality BEHAVIORAL

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).

Project Personality

Sharing Feelings Intervention BEHAVIORAL

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.

Sharing Feelings Intervention

Eligibility Criteria

• Age: 11 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stony Brook University: lead
• Society of Clinical Child & Adolescent Psychology: collaborator
• Autism Research Institute: collaborator

Study Sites (1)

Stony Brook University

Stony Brook, New York, 11794, United States

RECRUITING

Related Publications (7)

• Buescher AV, Cidav Z, Knapp M, Mandell DS. Costs of autism spectrum disorders in the United Kingdom and the United States. JAMA Pediatr. 2014 Aug;168(8):721-8. doi: 10.1001/jamapediatrics.2014.210.

  PMID: 24911948 BACKGROUND

• Kazdin AE, Blase SL. Rebooting Psychotherapy Research and Practice to Reduce the Burden of Mental Illness. Perspect Psychol Sci. 2011 Jan;6(1):21-37. doi: 10.1177/1745691610393527. Epub 2011 Feb 3.

  PMID: 26162113 BACKGROUND

• Schleider JL, Weisz JR. Little Treatments, Promising Effects? Meta-Analysis of Single-Session Interventions for Youth Psychiatric Problems. J Am Acad Child Adolesc Psychiatry. 2017 Feb;56(2):107-115. doi: 10.1016/j.jaac.2016.11.007. Epub 2016 Nov 25.

  PMID: 28117056 BACKGROUND

• 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: 28921523 BACKGROUND

• 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

• Stice E, Burton E, Bearman SK, Rohde P. Randomized trial of a brief depression prevention program: an elusive search for a psychosocial placebo control condition. Behav Res Ther. 2007 May;45(5):863-76. doi: 10.1016/j.brat.2006.08.008. Epub 2006 Sep 27.

  PMID: 17007812 BACKGROUND

• Aronson, E. (1999). The Power of Self-Persuasion. The American Psychologist, 54(11), 875-884. https://doi.org/10.1037/h0088188

  BACKGROUND

MeSH Terms

Conditions

Autism Spectrum Disorder; Anxiety Disorders; Depression; Autistic Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Joseph P Giacomantonio, B.S

  Stony Brook University

  STUDY DIRECTOR

Central Study Contacts

Matthew D Lerner, PhD

CONTACT

631-632-7660; Matthew.Lerner@stonybrook.edu

Joseph P Giacomantonio, B.S

CONTACT

631-632-7857; joseph.giacomantonio@stonybrook.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Participants in the study will be masked by using Qualtrics built in randomization function.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: This study will be a two-arm randomized controlled trial, including one active intervention conditions and one active control condition. Adolescents (and one caregiver per adolescent participant) will visit the Social Competence and Treatment Lab in the Department of Psychology at Stony Brook University. This lab visit will last approximately 2.5 hours. Adolescents and parents will complete baseline questionnaires (see sections below for details). Participants will then be randomized to one of two intervention conditions, using Qualtrics built in functionality: the single session growth mindset intervention (SSI GMI), or an active control program, designed to replicate supportive therapy (ST) and tested in previous work. Immediately after intervention completion, adolescents will complete a brief post-intervention questionnaire battery. Adolescents and parents will then be asked to complete online follow-up questionnaire batteries 3-months post-intervention.

Study Record Dates

• First Submitted: December 18, 2019
• First Posted: December 23, 2019
• Study Start: January 7, 2019
• Primary Completion: December 1, 2021
• Study Completion: March 1, 2022
• Last Updated: March 18, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)