- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04208425
Promoting Resilience in Teens With ASD (PRITA)
March 17, 2020 updated by: Matthew Daniel Lerner, Stony Brook University
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Matthew D Lerner, PhD
- Phone Number: 631-632-7660
- Email: Matthew.Lerner@stonybrook.edu
Study Contact Backup
- Name: Joseph P Giacomantonio, B.S
- Phone Number: 631-632-7857
- Email: joseph.giacomantonio@stonybrook.edu
Study Locations
-
-
New York
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Stony Brook, New York, United States, 11794
- Recruiting
- Stony Brook University
-
Contact:
- Joseph P Giacomantonio, B.S
- Phone Number: 631-632-7857
- Email: joseph.giacomantonio@stonybrook.edu
-
Contact:
- Matthew D Lerner, Ph.D
- Phone Number: 631-632-7660
- Email: matthew.lerner@stonybrook.edu
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Principal Investigator:
- Matthew D Lerner, Ph.D
-
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
11 years to 16 years (CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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).
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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.
|
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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up to 1 hour Pre-intervention
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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.
|
3-moth followup
|
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.
|
up to 1 hour Pre-intervention
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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.
|
3-moth followup
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Brief Symptom Inventory 18 (BSI-18)
Time Frame: up to 1 hour Pre-intervention
|
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.
|
up to 1 hour Pre-intervention
|
Brief Symptom Inventory 18 (BSI-18)
Time Frame: 3-month followup
|
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.
|
3-month followup
|
Multidimensional Anxiety Scale for Children-2 (MASC-2)
Time Frame: up to 1 hour Pre-intervention
|
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.
|
up to 1 hour Pre-intervention
|
Multidimensional Anxiety Scale for Children-2 (MASC-2)
Time Frame: 3-month followup
|
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.
|
3-month followup
|
Primary Control Scale for Children (PCSC)
Time Frame: up to 1 hour Pre-intervention
|
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.
|
up to 1 hour Pre-intervention
|
Primary Control Scale for Children (PCSC)
Time Frame: up to 1 hour Post-intervention
|
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.
|
up to 1 hour Post-intervention
|
Primary Control Scale for Children (PCSC)
Time Frame: 3-month followup
|
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.
|
3-month followup
|
Secondary Control Scale for Children (SCSC)
Time Frame: up to 1 hour Pre-intervention
|
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.
|
up to 1 hour Pre-intervention
|
Secondary Control Scale for Children (SCSC)
Time Frame: up to 1 hour Post-intervention
|
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.
|
up to 1 hour Post-intervention
|
Secondary Control Scale for Children (SCSC)
Time Frame: 3-month followup
|
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.
|
3-month followup
|
Social Responsiveness Scale-2 (SRS-2)
Time Frame: up to 1 hour Pre-intervention
|
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.
|
up to 1 hour Pre-intervention
|
Social Responsiveness Scale-2 (SRS-2)
Time Frame: 3-moth followup
|
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.
|
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 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.
|
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 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.
|
up to 1 hour Post-intervention
|
The Self Perception Profile for Children/ Adolescents (SPPC/A) self-report
Time Frame: 3-month followup
|
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.
|
3-month followup
|
Implicit Personality Theory Questionnaire (ITPQ)
Time Frame: up to 1 hour Pre-intervention
|
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.
|
up to 1 hour Pre-intervention
|
Implicit Personality Theory Questionnaire (ITPQ)
Time Frame: up to 1 hour Post-intervention
|
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.
|
up to 1 hour Post-intervention
|
Implicit Personality Theory Questionnaire (ITPQ)
Time Frame: 3-month followup
|
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.
|
3-month followup
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Joseph P Giacomantonio, B.S, Stony Brook University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Aronson, E. (1999). The Power of Self-Persuasion. The American Psychologist, 54(11), 875-884. https://doi.org/10.1037/h0088188
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 7, 2019
Primary Completion (ANTICIPATED)
December 1, 2021
Study Completion (ANTICIPATED)
March 1, 2022
Study Registration Dates
First Submitted
December 18, 2019
First Submitted That Met QC Criteria
December 20, 2019
First Posted (ACTUAL)
December 23, 2019
Study Record Updates
Last Update Posted (ACTUAL)
March 18, 2020
Last Update Submitted That Met QC Criteria
March 17, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB2019-00280
- AWD00001042 (OTHER_GRANT: Society of Clinical Child & Adolescent Psychology)
- AWD00001244 (OTHER_GRANT: Autism Research Institute)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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