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

Sponsor
Public Health Management Corporation (Other)
Overall Status
Unknown status
CT.gov ID
NCT04005547
Collaborator
Temple University (Other)
250
1
2
40.6
6.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Promoting Awareness through Live Movement and Sound for youth with Autism Spectrum Disorder
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
250 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
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)
Actual Study Start Date :
Sep 15, 2017
Anticipated Primary Completion Date :
Feb 1, 2021
Anticipated Study Completion Date :
Feb 1, 2021

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. unsafe sex self-report survey item [6 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 = 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).

    2. 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 = 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).

    3. 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)

    4. 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

    5. sexual health empowerment self-report survey scale [6 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

    6. 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

    7. self-protective boundary knowledge self-report survey scale [6 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.

    8. 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

    1. sexual health efficacy self-report survey, item or scale [6 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

    2. 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

    Other Outcome Measures

    1. reasons for singleness [6 months]

      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.

    2. reasons for singleness [12 months]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    14 Years to 19 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Public Health Management Corporation Philadelphia Pennsylvania United States 19102

    Sponsors and Collaborators

    • Public Health Management Corporation
    • Temple University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Public Health Management Corporation
    ClinicalTrials.gov Identifier:
    NCT04005547
    Other Study ID Numbers:
    • PublicHMC
    • 90AP2690-01-00
    First Posted:
    Jul 2, 2019
    Last Update Posted:
    Jul 2, 2019
    Last Verified:
    Jun 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Public Health Management Corporation
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 2, 2019