Autism Spectrum DisorderPRITANCT04208425

Promoting Resilience in Teens With ASD

A study testing Project Personality and Sharing Feelings Intervention in people with Autism Spectrum Disorder, run by Stony Brook University at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

Search all trials

Trial summary

Who is it for?: Ages 11 to 16 years
Conditions the study is for: Autism Spectrum Disorder
What is being tested?: Project Personality and Sharing Feelings Intervention
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteUnited States
Study dates: 7 Jan 2019to Mar 2022
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 11 to 16 years
All sexes
No healthy volunteers
Child

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

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

United States1 site, 1 recruiting

Stony Brook University
Stony Brook, New York, 11794
Joseph P Giacomantonio, B.S, 631-632-7857, joseph.giacomantonio@stonybrook.edu
Matthew D Lerner, Ph.D, 631-632-7660, matthew.lerner@stonybrook.edu
Recruiting

Other trials in United States

About this study

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.

Read the detailed description

Interventions for core and co-occurring symptoms of autism spectrum disorders (ASD) are almost uniformly costly and time-intensive, blunting dissemination of intervention and stymying opportunities to make scalable, population-level impact. One promising solution to this problem is a new class of evidence-based treatments, single-session interventions (SSIs), which have shown remarkable efficacy in treating a range of other developmental psychopathologies. No study to date has examined SSIs in youth with ASD, which, if even marginally effective, could dramatically reduce the cost and expand the public health impact of accessible intervention options for ASD. This study offers the first pilot randomized controlled trial (RCT) of whether an SSI shown to reduce internalizing problems in typically-developing youth may improve core and co-occurring symptoms of ASD.

Conditions: Autism Spectrum Disorder
Being tested: Project Personality, Sharing Feelings Intervention
Keywords: Anxiety, Depression, Autism, Autism Spectrum Disorder, Single Session Intervention, ASD, SSI
Medical subject headings: Autism Spectrum Disorder, Anxiety Disorders, Depression, Autistic Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Project PersonalityBehavioural
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 InterventionBehavioural
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.

Study groups in NCT04208425
Study group	Role	What they receive
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. Receives: 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. Receives: Behavioral: Sharing Feelings Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3-moth followup

Secondary outcomes (18)

Brief Symptom Inventory 18 (BSI-18)
The Brief Symptom Inventory 18 (BSI-18) is a valid, reliable screening tool for adult (here, parental) psychological distress. Adult respondents rate endorsement of 18 physical and emotional complaints on a 0-4 Likert scale (0 = Not at all; 4 = Extremely), yielding a total between 0 and 72 with a higher score indicating increased parental stress. The BSI-18 includes 3 subscales for somatic, anxiety, and depressive symptoms, respectively. The total sum score yields an additional total distress score. The BSI-18 will take approximately 4 minutes to complete.
Measured: up to 1 hour Pre-intervention
Brief Symptom Inventory 18 (BSI-18)
The Brief Symptom Inventory 18 (BSI-18) is a valid, reliable screening tool for adult (here, parental) psychological distress. Adult respondents rate endorsement of 18 physical and emotional complaints on a 0-4 Likert scale (0 = Not at all; 4 = Extremely), yielding a total between 0 and 72 with a higher score indicating increased parental stress. The BSI-18 includes 3 subscales for somatic, anxiety, and depressive symptoms, respectively. The total sum score yields an additional total distress score. The BSI-18 will take approximately 4 minutes to complete.
Measured: 3-month followup
Multidimensional Anxiety Scale for Children-2 (MASC-2)
The Multidimensional Anxiety Scale for Children-2 (MASC-2) is widely-used in ASD studies. The parent- and self-report versions appear to measure the same construct in youths receiving the intervention and active control. It will be included in obtained models to see whether it alters patterns of effects. The MASC-2 will take approximately 15 minutes to complete. Each item is scored 0-3 (0 = Never; 3 = Often), yielding a total score between 0 and 150 with a higher total score indicating increased symptom severity.
Measured: up to 1 hour Pre-intervention
Multidimensional Anxiety Scale for Children-2 (MASC-2)
The Multidimensional Anxiety Scale for Children-2 (MASC-2) is widely-used in ASD studies. The parent- and self-report versions appear to measure the same construct in youths receiving the intervention and active control. It will be included in obtained models to see whether it alters patterns of effects. The MASC-2 will take approximately 15 minutes to complete. Each item is scored 0-3 (0 = Never; 3 = Often), yielding a total score between 0 and 150 with a higher total score indicating increased symptom severity.
Measured: 3-month followup
Primary Control Scale for Children (PCSC)
The Primary Control Scale for Children (PCSC) is a 24-item scale measuring youths' perceived ability to influence or alter objective events or conditions through personal effort. Youth rate agreement with statements about their ability to exert primary control (e.g., "I can do well on tests if I study hard"; "I can get other kids to like me if I try"). This PCSC has shown acceptable internal consistency, 6-month test-retest reliability, and strong inverse relations to adolescent depressive symptoms. The PCSC will take approximately 10 minutes to complete. Each item is scored 0-3, yielding a total score between 0 and 72, with an decreased total score indicating decreased ability to exert primary control.
Measured: up to 1 hour Pre-intervention
Primary Control Scale for Children (PCSC)
The Primary Control Scale for Children (PCSC) is a 24-item scale measuring youths' perceived ability to influence or alter objective events or conditions through personal effort. Youth rate agreement with statements about their ability to exert primary control (e.g., "I can do well on tests if I study hard"; "I can get other kids to like me if I try"). This PCSC has shown acceptable internal consistency, 6-month test-retest reliability, and strong inverse relations to adolescent depressive symptoms. The PCSC will take approximately 10 minutes to complete. Each item is scored 0-3, yielding a total score between 0 and 72, with an decreased total score indicating decreased ability to exert primary control.
Measured: up to 1 hour Post-intervention
Primary Control Scale for Children (PCSC)
The Primary Control Scale for Children (PCSC) is a 24-item scale measuring youths' perceived ability to influence or alter objective events or conditions through personal effort. Youth rate agreement with statements about their ability to exert primary control (e.g., "I can do well on tests if I study hard"; "I can get other kids to like me if I try"). This PCSC has shown acceptable internal consistency, 6-month test-retest reliability, and strong inverse relations to adolescent depressive symptoms. The PCSC will take approximately 10 minutes to complete. Each item is scored 0-3, yielding a total score between 0 and 72, with an decreased total score indicating decreased ability to exert primary control.
Measured: 3-month followup
Secondary Control Scale for Children (SCSC)
The Secondary Control Scale for Children (SCSC) is a 20-item scale measuring youths' perceived ability to shape the personal impact of objective conditions on oneself, by adjusting oneself to fit those conditions. Youth rate agreement with items reflecting various kinds of secondary control, such as adjusting cognition ("When something bad happens, I can find a way to think about it that makes me feel better"). The SCSC has shown acceptable reliability and validity in a large youth sample. The SCSC will take approximately 5 minutes to complete. Each item is scored 0-3, yielding a total score between 0 and 60, with an decreased total score indicating decreased ability to exert primary control.
Measured: up to 1 hour Pre-intervention
Secondary Control Scale for Children (SCSC)
The Secondary Control Scale for Children (SCSC) is a 20-item scale measuring youths' perceived ability to shape the personal impact of objective conditions on oneself, by adjusting oneself to fit those conditions. Youth rate agreement with items reflecting various kinds of secondary control, such as adjusting cognition ("When something bad happens, I can find a way to think about it that makes me feel better"). The SCSC has shown acceptable reliability and validity in a large youth sample. The SCSC will take approximately 5 minutes to complete. Each item is scored 0-3, yielding a total score between 0 and 60, with an decreased total score indicating decreased ability to exert primary control.
Measured: up to 1 hour Post-intervention
Secondary Control Scale for Children (SCSC)
The Secondary Control Scale for Children (SCSC) is a 20-item scale measuring youths' perceived ability to shape the personal impact of objective conditions on oneself, by adjusting oneself to fit those conditions. Youth rate agreement with items reflecting various kinds of secondary control, such as adjusting cognition ("When something bad happens, I can find a way to think about it that makes me feel better"). The SCSC has shown acceptable reliability and validity in a large youth sample. The SCSC will take approximately 5 minutes to complete. Each item is scored 0-3, yielding a total score between 0 and 60, with an decreased total score indicating decreased ability to exert primary control.
Measured: 3-month followup
Social Responsiveness Scale-2 (SRS-2)
The Social Responsiveness Scale-2 (SRS-2) is a 65-item scale measuring the parent's perceived presence, and severity, of current social deficits. Changes in the SRS-2 from baseline to the follow-up assessment will serve as the secondary index of intervention effects. The SRS-2 will take approximately 15 minutes to complete. Each item is scored 1-4, yielding a total score between 65 and 260 with a higher total score indicating increased deficiencies.
Measured: up to 1 hour Pre-intervention
Social Responsiveness Scale-2 (SRS-2)
The Social Responsiveness Scale-2 (SRS-2) is a 65-item scale measuring the parent's perceived presence, and severity, of current social deficits. Changes in the SRS-2 from baseline to the follow-up assessment will serve as the secondary index of intervention effects. The SRS-2 will take approximately 15 minutes to complete. Each item is scored 1-4, yielding a total score between 65 and 260 with a higher total score indicating increased deficiencies.
Measured: 3-moth followup
The Self Perception Profile for Children/ Adolescents (SPPC/A) self-report
The Self Perception Profile for Children/ Adolescents (SPPC/A) self-report is a short questionnaire that measures the self-esteem of youth. This measure will be administered in lab to parents and children. All SPPC/A will be administered by research assistants. The SPPC/A will take approximately 5 minutes to complete. Each item is scored 1-4, yielding a total score between 10 and 40 with a higher total score indicating increased social competence.
Measured: up to 1 hour Pre-intervention
The Self Perception Profile for Children/ Adolescents (SPPC/A) self-report
The Self Perception Profile for Children/ Adolescents (SPPC/A) self-report is a short questionnaire that measures the self-esteem of youth. This measure will be administered in lab to parents and children. All SPPC/A will be administered by research assistants. The SPPC/A will take approximately 5 minutes to complete. Each item is scored 1-4, yielding a total score between 10 and 40 with a higher total score indicating increased social competence.
Measured: up to 1 hour Post-intervention
The Self Perception Profile for Children/ Adolescents (SPPC/A) self-report
The Self Perception Profile for Children/ Adolescents (SPPC/A) self-report is a short questionnaire that measures the self-esteem of youth. This measure will be administered in lab to parents and children. All SPPC/A will be administered by research assistants. The SPPC/A will take approximately 5 minutes to complete. Each item is scored 1-4, yielding a total score between 10 and 40 with a higher total score indicating increased social competence.
Measured: 3-month followup
Implicit Personality Theory Questionnaire (ITPQ)
The IPTQ asks youth to rate the extent of their agreement with three statements linked to the malleability of personality, using a 1-to-7 Likert scale (e.g. "Your personality is something about you that you can't change very much"). Higher summed scores on these three items indicate a stronger fixed personality mindset, a lower scores, a stronger growth personality mindset. The ITPQ will take approximately 4 minutes to complete.
Measured: up to 1 hour Pre-intervention
Implicit Personality Theory Questionnaire (ITPQ)
The IPTQ asks youth to rate the extent of their agreement with three statements linked to the malleability of personality, using a 1-to-7 Likert scale (e.g. "Your personality is something about you that you can't change very much"). Higher summed scores on these three items indicate a stronger fixed personality mindset, a lower scores, a stronger growth personality mindset. The ITPQ will take approximately 4 minutes to complete.
Measured: up to 1 hour Post-intervention
Implicit Personality Theory Questionnaire (ITPQ)
The IPTQ asks youth to rate the extent of their agreement with three statements linked to the malleability of personality, using a 1-to-7 Likert scale (e.g. "Your personality is something about you that you can't change very much"). Higher summed scores on these three items indicate a stronger fixed personality mindset, a lower scores, a stronger growth personality mindset. The ITPQ will take approximately 4 minutes to complete.
Measured: 3-month followup

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Jan 2019Mar 2022

First posted23 Dec 2019
Study start7 Jan 2019
Primary completionDec 2021 (estimated)
Study completionMar 2022 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (7)Papers the sponsor has linked to this study.
Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: 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.
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 40 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04208425
Sponsor's protocol ID: IRB2019-00280
Other IDs: AWD00001042, AWD00001244
Acronym: PRITA
Status last verified: Mar 2020
First submitted: 18 Dec 2019
Last updated: 18 Mar 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 24911948
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.
PubMed 26162113
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.
PubMed 28117056
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.
PubMed 28921523
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.
PubMed 27697671
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.
PubMed 17007812
Aronson, E. (1999). The Power of Self-Persuasion. The American Psychologist, 54(11), 875-884. https://doi.org/10.1037/h0088188

Study at a glance

From the registry record, last updated by the sponsor on 18 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Promoting Resilience in Teens With ASD
ClinicalTrials.gov ID: NCT04208425
Acronym / sponsor ID: PRITA / IRB2019-00280
Conditions: Autism Spectrum Disorder
Keywords: Anxiety, Depression, Autism, Autism Spectrum Disorder, Single Session Intervention, ASD, SSI
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 40 participants (estimated)
Lead sponsor: Stony Brook UniversityUniversity, hospital or other
Collaborators: Society of Clinical Child & Adolescent Psychology, Autism Research Institute
Study start: 7 Jan 2019 (actual)
Primary completion: Dec 2021 (estimated)
Study completion: Mar 2022 (estimated)
First posted: 23 Dec 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2
Model description: 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.

Arm	Type	Receives
Project Personality	Experimental	Behavioral: Project PersonalityThe 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.
Sharing Feelings Intervention	Active comparator	Behavioral: Sharing Feelings InterventionThe 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.

Who may qualify

Ages: 11 to 16 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (7 listed)

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;

Key exclusion criteria (5 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Project PersonalityThe 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).	Behavioural	Project Personality
Sharing Feelings InterventionThe 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.	Behavioural	Sharing Feelings Intervention

Primary outcome

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

18 secondary outcomes

Brief Symptom Inventory 18 (BSI-18)
Time frame: up to 1 hour Pre-intervention
Brief Symptom Inventory 18 (BSI-18)
Time frame: 3-month followup
Multidimensional Anxiety Scale for Children-2 (MASC-2)
Time frame: up to 1 hour Pre-intervention
Multidimensional Anxiety Scale for Children-2 (MASC-2)
Time frame: 3-month followup
Primary Control Scale for Children (PCSC)
Time frame: up to 1 hour Pre-intervention
Primary Control Scale for Children (PCSC)
Time frame: up to 1 hour Post-intervention
Primary Control Scale for Children (PCSC)
Time frame: 3-month followup
Secondary Control Scale for Children (SCSC)
Time frame: up to 1 hour Pre-intervention
Secondary Control Scale for Children (SCSC)
Time frame: up to 1 hour Post-intervention
Secondary Control Scale for Children (SCSC)
Time frame: 3-month followup
Social Responsiveness Scale-2 (SRS-2)
Time frame: up to 1 hour Pre-intervention
Social Responsiveness Scale-2 (SRS-2)
Time frame: 3-moth followup
The Self Perception Profile for Children/ Adolescents (SPPC/A) self-report
Time frame: up to 1 hour Pre-intervention
The Self Perception Profile for Children/ Adolescents (SPPC/A) self-report
Time frame: up to 1 hour Post-intervention
The Self Perception Profile for Children/ Adolescents (SPPC/A) self-report
Time frame: 3-month followup
Implicit Personality Theory Questionnaire (ITPQ)
Time frame: up to 1 hour Pre-intervention
Implicit Personality Theory Questionnaire (ITPQ)
Time frame: up to 1 hour Post-intervention
Implicit Personality Theory Questionnaire (ITPQ)
Time frame: 3-month followup

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2020.
Background: PubMed 24911948Buescher 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.
Background: PubMed 26162113Kazdin 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.
Background: PubMed 28117056Schleider 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.
Background: PubMed 28921523Schleider 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.
Background: PubMed 27697671Schleider 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.
Background: PubMed 17007812Stice 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.
BackgroundAronson, E. (1999). The Power of Self-Persuasion. The American Psychologist, 54(11), 875-884. https://doi.org/10.1037/h0088188
Individual participant dataSharing planned: No

Related trials for Autism Spectrum Disorder

Recruiting
Effectiveness of Clown Therapy in Facilitating Dental Visits for Children With Autism Spectrum Disorder
Autism Spectrum Disorder (ASD
Recruiting
Cerebellar Transcranial Direct Current Stimulation (tDCS) in Children With Autism Spectrum Disorder: Raynor Cerebellum Project
Autism Spectrum Disorder
Not yet recruiting
QAIAx - SGI/SI Smart Health Cities: Microcity Enclave Program (Quantum SI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360; USPTO EO 9424 Assignment ID: 2101042 / ARN: REEL/FRAME: 76481/0026 - OUSD-R&E, Department of War)
Asperger's Disorder, Asperger Disorder
Not yet recruiting
Transdiagnostic Sleep and Circadian Treatment for Autistic Adolescents
Sleep, Autism Spectrum Disorder
RecruitingObservational study
Effectiveness of the Autism Pupil Screen (APS) Detect Pupillometer for Identifying Autism Spectrum Disorder (ASD) in Routine Healthcare
Autism Spectrum Disorder

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

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

Joseph P Giacomantonio, B.S study director

Stony Brook University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Project Personality and Sharing Feelings Intervention in people with Autism Spectrum Disorder, run by Stony Brook University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 18 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Matthew D Lerner, PhD (631-632-7660, Matthew.Lerner@stonybrook.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Children's Depression Inventory-2 (CDI-2) (time frame: up to 1 hour Pre-intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04208425, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2020.