Clinical trial NCT04005547: Health Education and Relationships Through Theater: An RCT of Promoting Awareness Through Live Movement and Sound for Youth With Autism Spectrum Disorder (PALMS-ASD)
Official title: Health Education and Relationships Through Theater: A Randomized Controlled Trial of Promoting Awareness Through Live Movement and Sound for Youth With Autism Spectrum Disorder (PALMS-ASD)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Sexual Health
Education, Health
Keywords: sexual health
Autism Spectrum Disorders
Lead sponsor: Public Health Management Corporation
Sponsor class: OTHER
Collaborators: name: Temple University
First posted: 2019-07-02
Enrollment: 72
Sex: ALL
Minimum age (years): 14
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Teens with ASD ages 14-19 will be screened for eligibility, complete a baseline interviewer/ACASI-administered survey, and randomly assigned to either intervention or control group. The enrollment goal is 500 teens. The 12-hour intervention will be run in groups of up to 12 teens, with health educators leading the group and actors assisting, role playing with participants, and performing a skit. Teens in the intervention group will take a post satisfaction survey, and teens in both conditions will take a 6-month and 12-month interviewer/ACASI-administered outcome survey. Fidelity will be monitored by observers and rated by health educators.


Eligibility criteria: Inclusion Criteria:

* meets age limits and
* parent/self-identifying as having an autism spectrum disorder, Asperger's Syndrome, or autism-similar social challenges, and/or
* mild intellectual disability

Exclusion Criteria:

* screen-out with screening tool, if not screened in by documented staff observation

  * Hospitalization within the last 3 months for a behavioral or mental cause
  * Inability to participate in group setting (sensory, extreme social/communication challenges)
  * Previous criminal conviction for sex offense
  * Sibling previously randomized to control
* screen-out with KBIT-2: Score \< 50 OR Score above 70 on KBIT-2 and not receiving services for or having a diagnosis of ASD
* capacity to consent

Primary outcomes:
measure: unsafe sex self-report survey item
timeFrame: 6 months
measure: unsafe sex self-report survey item
timeFrame: 12 months
measure: sexual health knowledge self-report survey scale
timeFrame: 6 months
measure: adult-teen communication youth-report survey scale
timeFrame: 6 months
measure: sexual health empowerment self-report survey scale
timeFrame: 6 months
measure: sexual health empowerment self-report survey scale
timeFrame: 12 months
measure: self-protective boundary knowledge self-report survey scale
timeFrame: 6 months
measure: self-protective boundary knowledge self-report survey scale
timeFrame: 12 months
Secondary outcomes:
measure: sexual health efficacy self-report survey, item or scale
timeFrame: 6 months
measure: sexual health efficacy self-report survey, item or scale
timeFrame: 12 months
Other outcomes:
measure: reasons for singleness
timeFrame: 6 months
measure: reasons for singleness
timeFrame: 12 months
Locations:
city: Philadelphia
country: United States
facility: Public Health Management Corporation
state: Pennsylvania
Study officials:
References: