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Promoting Resilience in Teens With ASD

Not Applicable
Conditions
Autism Spectrum Disorder
Interventions
Behavioral: Project Personality
Behavioral: Sharing Feelings Intervention
Registration Number
NCT04208425
Lead Sponsor
Stony Brook University
Brief Summary

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

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.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
40
Inclusion Criteria
  • Youth between the ages of 11-16 (inclusive) at the time of study participation;
  • Youth with one parent or legal guardian willing to participate in the study (i.e. to be present for the lab visit and to complete questionnaires throughout the study period);
  • Youth speaks English well enough to complete online or virtual based intervention activities;
  • Youth with IQ ≥ 70;
  • Parent or legal guardian speaks English well enough to complete online questionnaires;
  • Youth with SCQ >10;
  • Youth who meet criteria for autism or ASD on the ADOS-2.
Exclusion Criteria
  • Failure to meet the above inclusion criteria;
  • Intellectual disability (IQ<70), as this may undermine comprehension of intervention materials;
  • Adolescent is non-English speaking;
  • The presence of a known developmental disability aside from ASD that would interfere with study participation;
  • The presence of a significant medical disability or disorder that would interfere with study participation.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Project PersonalityProject 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 InterventionSharing 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.
Primary Outcome Measures
NameTimeMethod
Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2)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.

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

Secondary Outcome Measures
NameTimeMethod
Multidimensional Anxiety Scale for Children-2 (MASC-2)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.

Brief Symptom Inventory 18 (BSI-18)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.

Primary Control Scale for Children (PCSC)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.

Implicit Personality Theory Questionnaire (ITPQ)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.

Secondary Control Scale for Children (SCSC)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.

Social Responsiveness Scale-2 (SRS-2)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.

The Self Perception Profile for Children/ Adolescents (SPPC/A) self-report3-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.

Trial Locations

Locations (1)

Stony Brook University

🇺🇸

Stony Brook, New York, United States

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