Promoting Resilience in Teens With ASD (PRITA)

Stony Brook University

Status: Unknown

Conditions: Autism Spectrum Disorder

Treatments: Behavioral: Project Personality; Behavioral: Sharing Feelings Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT04208425

IRB2019-00280

AWD00001244 (Other Grant/Funding Number)

AWD00001042 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 11 to 16 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

Project Personality

Experimental group

Description:

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.

Treatment:

Behavioral: Project Personality

Sharing Feelings Intervention

Active Comparator group

Description:

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.

Treatment:

Behavioral: Sharing Feelings Intervention