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

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)

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04005547
Acronym
HEART
Enrollment
72
Registered
2019-07-02
Start date
2017-09-15
Completion date
2020-05-31
Last updated
2023-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Education, Health, Sexual Health

Keywords

sexual health, Autism Spectrum Disorders

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.

Interventions

BEHAVIORALPromoting 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

Sponsors

Temple University
CollaboratorOTHER
Public Health Management Corporation
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
14 Years to 19 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
sexual health knowledge self-report survey scale6 monthssum 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 scale6 monthspartner 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
self-protective boundary knowledge self-report survey scale6 monthsknowledge 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.
unsafe sex self-report survey item6 monthsFrequency 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).
adult-teen communication youth-report survey scale6 monthscomfort 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

Secondary

MeasureTime frameDescription
sexual health efficacy self-report survey, item or scale6 monthsSexual 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

Other

MeasureTime frameDescription
reasons for singleness6 monthsStrunz 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 1. = I haven't yet met anybody with whom I could imagine having a romantic relationship 2. = I am afraid of not fulfilling my partner's expectations 3. = I don't know how to meet a potential partner 4. = I don't know how a romantic relationship works or how to behave in a romantic relationship 5. = I don't like the physical contact a romantic relationship brings with it 6. = Sexual activities are unpleasant for me 7. = I simply don't feel the need for a romantic relationship 8. = 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026