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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

Tracking Information
First Submitted Date  ICMJE April 13, 2018
First Posted Date  ICMJE July 2, 2019
Last Update Posted Date July 2, 2019
Actual Study Start Date  ICMJE September 15, 2017
Estimated Primary Completion Date February 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 28, 2019)
  • 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).
  • 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).
  • 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)
  • 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
  • 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
  • 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
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 28, 2019)
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: June 28, 2019)
  • 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.
  • 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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Health Education and Relationships Through Theater: An RCT of Promoting Awareness Through Live Movement and Sound for Youth With Autism Spectrum Disorder (PALMS-ASD)
Official Title  ICMJE 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)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Sexual Health
  • Education, Health
Intervention  ICMJE 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
Study Arms  ICMJE
  • Experimental: Program+survey
    Intervention: Behavioral: Promoting Awareness through Live Movement and Sound for youth with Autism Spectrum Disorder
  • No Intervention: Survey-only
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 28, 2019)
250
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2021
Estimated Primary Completion Date February 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 14 Years to 19 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04005547
Other Study ID Numbers  ICMJE PublicHMC
90AP2690-01-00 ( Other Grant/Funding Number: Family and Youth Services Bureau )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Public Health Management Corporation
Study Sponsor  ICMJE Public Health Management Corporation
Collaborators  ICMJE Temple University
Investigators  ICMJE Not Provided
PRS Account Public Health Management Corporation
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP