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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) (HEART)

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ClinicalTrials.gov Identifier: NCT04005547
Recruitment Status : Recruiting
First Posted : July 2, 2019
Last Update Posted : July 2, 2019
Sponsor:
Collaborator:
Temple University
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Sexual Health Education, Health Behavioral: Promoting Awareness through Live Movement and Sound for youth with Autism Spectrum Disorder Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : September 15, 2017
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine


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 Name: PALMS-ASD

No Intervention: Survey-only



Primary Outcome Measures :
  1. unsafe sex self-report survey item [ Time Frame: 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

      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).

  2. unsafe sex self-report survey item [ Time Frame: 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).

  3. sexual health knowledge self-report survey scale [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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

    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.


  2. reasons for singleness [ Time Frame: 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

    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.




Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04005547


Locations
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United States, Pennsylvania
Public Health Management Corporation Recruiting
Philadelphia, Pennsylvania, United States, 19102
Contact: Project Manager    215-731-2027    heartstudy@phmc.org   
Principal Investigator: Katharine T Hemady, PhD         
Sponsors and Collaborators
Public Health Management Corporation
Temple University

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Responsible Party: Public Health Management Corporation
ClinicalTrials.gov Identifier: NCT04005547     History of Changes
Other Study ID Numbers: PublicHMC
90AP2690-01-00 ( Other Grant/Funding Number: Family and Youth Services Bureau )
First Posted: July 2, 2019    Key Record Dates
Last Update Posted: July 2, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
sexual health
Autism Spectrum Disorders
Additional relevant MeSH terms:
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Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders