Sexual HealthHEARTNCT04005547
Health Education and Relationships Through Theater: An RCT of Promoting Awareness Through Live Movement and Sound for Youth With Autism Spectrum Disorder (PALMS-ASD)
A study testing Promoting Awareness through Live Movement and Sound for youth with Autism Spectrum Disorder in people with Sexual Health and Education, Health, run by Public Health Management Corporation at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Sexual Health, Education, Health
- What is being tested?
- Promoting Awareness through Live Movement and Sound for youth with Autism Spectrum Disorder
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2017to 31 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Public Health Management Corporation
Philadelphia, Pennsylvania, 19102
About this study
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)
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.
- Conditions
- Sexual Health, Education, Health
- Being tested
- Promoting Awareness through Live Movement and Sound for youth with Autism Spectrum Disorder
- Keywords
- sexual health, Autism Spectrum Disorders
- Medical subject headings
- Health Education, Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Promoting Awareness through Live Movement and Sound for youth with Autism Spectrum DisorderBehavioural
Also called PALMS-ASD
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
| Study group | Role | What they receive |
|---|---|---|
| Program+survey | Experimental | Not described Receives: Behavioral: Promoting Awareness through Live Movement and Sound for youth with Autism Spectrum Disorder |
| Survey-only | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
- = 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).
Measured: 6 months
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
- = 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).
Measured: 12 months
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)
Measured: 6 months
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
Measured: 6 months
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
Measured: 6 months
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
Measured: 12 months
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.
Measured: 6 months
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.
Measured: 12 months
Secondary outcomes (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
Measured: 6 months
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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2019
- Study start15 Sep 2017
- Primary completion12 Mar 2020
- Study completion31 May 2020
Why it stopped: Funding withdrawn
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexual HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Public Health Management Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- Temple University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04005547
- Sponsor's protocol ID
- PublicHMC
- Other IDs
- 90AP2690-01-00
- Acronym
- HEART
- Status last verified
- Nov 2023
- First submitted
- 13 Apr 2018
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04005547
- Acronym / sponsor ID
- HEART / PublicHMC
- Conditions
- Sexual Health, Education, Health
- Keywords
- sexual health, Autism Spectrum Disorders
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding withdrawn
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Public Health Management CorporationUniversity, hospital or other
- Collaborators
- Temple University
- Study start
- 15 Sep 2017 (actual)
- Primary completion
- 12 Mar 2020 (actual)
- Study completion
- 31 May 2020 (actual)
- First posted
- 2 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Program+survey | Experimental | Behavioral: Promoting Awareness through Live Movement and Sound for youth with Autism Spectrum Disorder |
| Survey-only | No intervention | – |
Who may qualify
- Ages
- 14 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- screen-out with screening tool, if not screened in by documented staff observation
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Promoting Awareness through Live Movement and Sound for youth with Autism Spectrum DisorderAlso: PALMS-ASDSession 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 | Behavioural | Program+survey |
Primary outcome
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.
2 secondary outcomes
sexual health efficacy self-report survey, item or scale
Time frame: 6 months
sexual health efficacy self-report survey, item or scale
Time frame: 12 months
Results and safety
The study was stopped early (reason given: Funding withdrawn). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Promoting Awareness through Live Movement and Sound for youth with Autism Spectrum Disorder in people with Sexual Health and Education, Health, run by Public Health Management Corporation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Funding withdrawn). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
unsafe sex self-report survey item (time frame: 6 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.