CClinicalTrials.gg
TerminatedNCT04005547HEARTUpdated Nov 18, 2023

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

An interventional study of Promoting Awareness through Live Movement and Sound for youth with Autism Spectrum Disorder in Sexual Health and Education, Health, sponsored by Public Health Management Corporation. Terminated at 1 site in United States. Open to participants aged 14 Years to 19 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-18.

Sponsored by Public Health Management Corporation · Not applicable, Interventional, and Prevention

Why this study was terminated
Funding withdrawn

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Sep 2017, registered Apr 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
72
Allocation
Randomized
Ages
14 Years to 19 Years
Sex
All
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Study 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.

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Conditions studied

  • Sexual Health
  • Education, Health

Keywords

  • sexual health
  • Autism Spectrum Disorders
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In context

Autism Spectrum Disorder

1,727 studies on the registry are indexed under Autism Spectrum Disorder; 504 are open to participants now.

This study's enrollment of 72 is above the median of 52 across 1,371 interventional studies indexed under Autism Spectrum Disorder.

Browse Autism Spectrum Disorder studies →

Lead sponsor

Public Health Management Corporation is the lead sponsor of 8 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
14 Years to 19 Years
Sexes eligible
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

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
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
72 participants (actual)

Study arms

  • Experimental
    Program+survey

    Behavioral: Promoting Awareness through Live Movement and Sound for youth with Autism Spectrum Disorder

  • No intervention
    Survey-only

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

    Also known as: PALMS-ASD

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What researchers measure

Primary outcomes

  1. 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 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).

    Time frame: 6 months

  2. 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 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).

    Time frame: 12 months

  3. 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)

    Time frame: 6 months

  4. 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

    Time frame: 6 months

  5. 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

    Time frame: 6 months

  6. 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

    Time frame: 12 months

  7. 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.

    Time frame: 6 months

  8. 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.

    Time frame: 12 months

Secondary outcomes

  1. 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

    Time frame: 6 months

  2. 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

    Time frame: 12 months

Other outcomes

  1. 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 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.

    Time frame: 6 months

  2. 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 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.

    Time frame: 12 months

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Study locations

1 site
  • Public Health Management Corporation
    Philadelphia, Pennsylvania 19102, United States
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 18, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04005547
Lead sponsor
Public Health Management Corporation
Collaborators
Temple University
Responsible party
Sponsor
First posted
Jul 2, 2019
Start date
Sep 15, 2017
Primary completion
Mar 12, 2020
Completion
May 31, 2020
Last update
Nov 18, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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