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

Sexual Health Clinical Trial

— HEART  

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04005547
• Other study ID #: PublicHMC
• Secondary ID: 90AP2690-01-00
• Status: Terminated
• Phase: N/A
• Start date: September 15, 2017
• Est. completion date: May 31, 2020

Study information

• Verified date: November 2023
• Source: Public Health Management Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 72
• Est. completion date: May 31, 2020
• Est. primary completion date: March 12, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 19 Years

Eligibility

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

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Education, Health
• Sexual Health

Intervention

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

Locations

Country	Name	City	State
United States	Public Health Management Corporation	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Public Health Management Corporation	Temple University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	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 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).	6 months
Primary	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 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).	12 months
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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