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| ID | Type | Description | Link |
|---|---|---|---|
| AWD00001042 | Other Grant/Funding Number | Society of Clinical Child & Adolescent Psychology | |
| AWD00001244 | Other Grant/Funding Number | Autism Research Institute |
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| Name | Class |
|---|---|
| Society of Clinical Child & Adolescent Psychology | UNKNOWN |
| Autism Research Institute | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
| Name | Affiliation | Role |
|---|---|---|
| Joseph P Giacomantonio, B.S | Stony Brook University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stony Brook University | Recruiting | Stony Brook | New York | 11794 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24911948 | Background | 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. | |
| 26162113 | 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. |
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| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| D001321 | Autistic Disorder |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
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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.
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Participants in the study will be masked by using Qualtrics built in randomization function.
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| 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. |
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| 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 |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 3-month followup |
| 28117056 | 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. |
| 28921523 | 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. |
| 27697671 | 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. |
| 17007812 | 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. |
| Background | Aronson, E. (1999). The Power of Self-Persuasion. The American Psychologist, 54(11), 875-884. https://doi.org/10.1037/h0088188 |
| D001519 | Behavior |