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

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)

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.

Study Overview

• Status: Terminated
• Conditions: Sexual Health; Education, Health
• Intervention / Treatment: Behavioral: Promoting Awareness through Live Movement and Sound for youth with Autism Spectrum Disorder

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19102
      • Public Health Management Corporation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 19 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Program+survey	Behavioral: Promoting Awareness through Live Movement and Sound for youth with Autism Spectrum Disorder; Session 1 - Let's Talk About Relationships Session 2 - Let's Talk About Intimate Relationships Session 3 - Let's Talk About Sex Session 4 - Let's Talk About Protection Session 5 - Let's Talk About Communication *Bring your Trusted Adult* Session 6 - Let's Talk About Growing Up; Other Names: PALMS-ASD
No Intervention: Survey-only

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
unsafe sex self-report survey item	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= I have had sex but not in the past 3 months= Once in the past 3 months= 2-3 times in the past 3 months= 4 or more times in the past 3 months8 = 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).	6 months
unsafe sex self-report survey item	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= I have had sex but not in the past 3 months= Once in the past 3 months= 2-3 times in the past 3 months= 4 or more times in the past 3 months8 = 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).	12 months
sexual health knowledge self-report survey scale	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)	6 months
adult-teen communication youth-report survey scale	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	6 months
sexual health empowerment self-report survey scale	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	6 months
sexual health empowerment self-report survey scale	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	12 months
self-protective boundary knowledge self-report survey scale	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.	6 months
self-protective boundary knowledge self-report survey scale	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.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
sexual health efficacy self-report survey, item or scale	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	6 months
sexual health efficacy self-report survey, item or scale	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	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
reasons for singleness	Strunz Q39. What prevents you from entering into a romantic relationship? Even if you are currently in a relationship, think about what prevented you from entering into a relationship before this. PREVREL What prevented a romantic relationship? 2 0 = Contact with others is too exhausting for me; = I haven't yet met anybody with whom I could imagine having a romantic relationship; = I am afraid of not fulfilling my partner's expectations; = I don't know how to meet a potential partner; = I don't know how a romantic relationship works or how to behave in a romantic relationship; = I don't like the physical contact a romantic relationship brings with it; = Sexual activities are unpleasant for me; = I simply don't feel the need for a romantic relationship; = Other reasons 98 = Refuse to Answer Descriptives will be examined to create binary, categorical or dummy variables to examine impact on Response options 2 and 4.	6 months
reasons for singleness	Strunz Q39. What prevents you from entering into a romantic relationship? Even if you are currently in a relationship, think about what prevented you from entering into a relationship before this. PREVREL What prevented a romantic relationship? 2 0 = Contact with others is too exhausting for me; = I haven't yet met anybody with whom I could imagine having a romantic relationship; = I am afraid of not fulfilling my partner's expectations; = I don't know how to meet a potential partner; = I don't know how a romantic relationship works or how to behave in a romantic relationship; = I don't like the physical contact a romantic relationship brings with it; = Sexual activities are unpleasant for me; = I simply don't feel the need for a romantic relationship; = Other reasons 98 = Refuse to Answer Descriptives will be examined to create binary, categorical or dummy variables to examine impact on Response options 2 and 4.	12 months

Collaborators and Investigators

• Sponsor: Public Health Management Corporation
• Collaborators: Temple University

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2017
• Primary Completion (Actual): March 12, 2020
• Study Completion (Actual): May 31, 2020

Study Registration Dates

• First Submitted: April 13, 2018
• First Submitted That Met QC Criteria: June 28, 2019
• First Posted (Actual): July 2, 2019

Study Record Updates

• Last Update Posted (Estimated): November 20, 2023
• Last Update Submitted That Met QC Criteria: November 16, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: sexual health; Autism Spectrum Disorders
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autism Spectrum Disorder
• Other Study ID Numbers: PublicHMC; 90AP2690-01-00 (Other Grant/Funding Number: Family and Youth Services Bureau)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No