Clinical trial NCT04208425: Promoting Resilience in Teens With ASD
Official title: Promoting Resilience in Teens With ASD
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: Anxiety
Depression
Autism
Autism Spectrum Disorder
Single Session Intervention
ASD
SSI
Lead sponsor: Stony Brook University
Sponsor class: OTHER
Collaborators: name: Society of Clinical Child & Adolescent Psychology
name: Autism Research Institute
First posted: 2019-12-23
Enrollment: 40
Sex: ALL
Minimum age (years): 11
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Children's Depression Inventory-2 (CDI-2)
timeFrame: up to 1 hour Pre-intervention
measure: Children's Depression Inventory-2 (CDI-2)
timeFrame: 3-moth followup
measure: Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2)
timeFrame: up to 1 hour Pre-intervention
measure: Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2)
timeFrame: 3-moth followup
Secondary outcomes:
measure: Brief Symptom Inventory 18 (BSI-18)
timeFrame: up to 1 hour Pre-intervention
measure: Brief Symptom Inventory 18 (BSI-18)
timeFrame: 3-month followup
measure: Multidimensional Anxiety Scale for Children-2 (MASC-2)
timeFrame: up to 1 hour Pre-intervention
measure: Multidimensional Anxiety Scale for Children-2 (MASC-2)
timeFrame: 3-month followup
measure: Primary Control Scale for Children (PCSC)
timeFrame: up to 1 hour Pre-intervention
measure: Primary Control Scale for Children (PCSC)
timeFrame: up to 1 hour Post-intervention
measure: Primary Control Scale for Children (PCSC)
timeFrame: 3-month followup
measure: Secondary Control Scale for Children (SCSC)
timeFrame: up to 1 hour Pre-intervention
measure: Secondary Control Scale for Children (SCSC)
timeFrame: up to 1 hour Post-intervention
measure: Secondary Control Scale for Children (SCSC)
timeFrame: 3-month followup
measure: Social Responsiveness Scale-2 (SRS-2)
timeFrame: up to 1 hour Pre-intervention
measure: Social Responsiveness Scale-2 (SRS-2)
timeFrame: 3-moth followup
measure: The Self Perception Profile for Children/ Adolescents (SPPC/A) self-report
timeFrame: up to 1 hour Pre-intervention
measure: The Self Perception Profile for Children/ Adolescents (SPPC/A) self-report
timeFrame: up to 1 hour Post-intervention
measure: The Self Perception Profile for Children/ Adolescents (SPPC/A) self-report
timeFrame: 3-month followup
measure: Implicit Personality Theory Questionnaire (ITPQ)
timeFrame: up to 1 hour Pre-intervention
measure: Implicit Personality Theory Questionnaire (ITPQ)
timeFrame: up to 1 hour Post-intervention
measure: Implicit Personality Theory Questionnaire (ITPQ)
timeFrame: 3-month followup
Other outcomes:
Locations:
city: Stony Brook
country: United States
facility: Stony Brook University
state: New York
Study officials:
affiliation: Stony Brook University
name: Joseph P Giacomantonio, B.S
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Aronson, E. (1999). The Power of Self-Persuasion. The American Psychologist, 54(11), 875-884. https://doi.org/10.1037/h0088188