Health Education and Relationships Through Theater: An RCT of Promoting Awareness Through Live Movement and Sound for Youth With Autism Spectrum Disorder (PALMS-ASD)

Not Applicable

Terminated

• Conditions: Sexual Health; Education, Health
• Interventions: Behavioral: Promoting Awareness through Live Movement and Sound for youth with Autism Spectrum Disorder

• Registration Number: NCT04005547
• Lead Sponsor: Public Health Management Corporation

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-09-15
• Study First Submitted: 2018-04-13
• Study First Submitted QC: 2019-06-28
• Study First Posted: 2019-07-02
• Primary Completion: 2020-03-12
• Study Completion: 2020-05-31
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-16
• Last Update Posted: 2023-11-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 72

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Program+survey	Promoting Awareness through Live Movement and Sound for youth with Autism Spectrum Disorder	-

Primary Outcome Measures

Name	Time	Method
adult-teen communication youth-report survey scale	6 months	comfort talking to a trusted adult about relationship/sexual health topics scale and/or having ever talked to a trusted adult about relationship/sexual health topics scale. Adapted for this study.; Citation Sexual Health Communication Scale Jaccard, Dittus, \& Gordon, 2000 Healthy Oakland Teen Silver, \& Bauman, 2006 Scales TACT: Mean of 11 items based on talking to a trusted adult about (topic) and being told not to talk about something by a trusted adult (yes, no; none, some, all: mixed response options within scale - will be recoded, higher scores better) TACX/TACSE: mean of 5 items: i feel comfortable talking with a trusted adult (about topic), could you tell a trusted adult or talk with a trusted adult about (topic/event), 0- 19, 19 better
sexual health knowledge self-report survey scale	6 months	sum of scored items (correct = 1/incorrect = 0): anatomy, STI prevention topics and pregnancy/birth control topics.; Adapted from: National Survey of Reproductive and Contraceptive Knowledge Frost, Lindberg, \& Finer, 2012 Healthy Oakland Teen Silver, \& Bauman, 2006 National Survey of Adolescents and Young Adults National Longitudinal Adolescent to Adult Health Survey Rostosky, Regnerus, \& Wright, "Coital Debut."; Up to 33 questions scored, pending item psychometric performance (possible scale range 0 - 33)
sexual health empowerment self-report survey scale	12 months	partner communication, boundary communication. Scale: Mean of 14 items. 0-19, score of 19 is better.; Adapted for this study from Smylie et al., 2013; Silver, \& Bauman, 2006
unsafe sex self-report survey item	12 months	Frequency of condom with vaginal sex in past three months among those sexually active (none of the time, some of the time, all of the time). Will be reported if sufficient segment of sample is sexually active.; PCM Q208. Have you EVER had vaginal sex? CMSEX; PCM Q209. In the past three months, how many times did you have vaginal sex? CMVTIM; Re-coded: PCM Q210. When you had vaginal sex in the past 3 months, how often did you or your partner use a condom? CMCNDM_R; Response Options; VSBO; * CMSEX No, Yes, Refuse (0= No, 1=Yes, 8=RTA). CMVTIM 0 = I have never had sex; 1. = I have had sex but not in the past 3 months; 2. = Once in the past 3 months; 3. = 2-3 times in the past 3 months; 4. = 4 or more times in the past 3 months; 8 = Refuse to Answer; * CMCNDM_R 1 'All of the time' .5 'Some of the time' 0 'None of the time' 8 'Missing'. (0= No, 1=Yes, 8=RTA).
self-protective boundary knowledge self-report survey scale	12 months	knowledge of legality of sexual behaviors and knowledge of sexual/relationship behaviors reflecting being taken advantage of in a relationship. Created for this study. Scale: 7 items; Subscales: legal knowledge (5 items); power imbalance/being taken advantage of knowledge (2 items). All items scored as incorrect=0, correct=1. Scale score is average, which can be interpreted as percent correct.

Secondary Outcome Measures

Name	Time	Method
sexual health efficacy self-report survey, item or scale	12 months	Sexual health self-efficacy Scale: Mean of 8 items. (condoms 3 items, birth control 2 items, STI testing 2 items, sexual health 1 item). 0-19, score of 19 is better.; Condom scale (3 items) Acquiring condom self-efficacy 1 item (Q188) Adapted for this study from Smylie et al., 2013; Silver, \& Bauman, 2006

Trial Locations

Locations (1)

Public Health Management Corporation; 🇺🇸 Philadelphia, Pennsylvania, United States