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)
Primary Purpose
Sexual Health, Education, Health
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Promoting Awareness through Live Movement and Sound for youth with Autism Spectrum Disorder
Sponsored by
About this trial
This is an interventional prevention trial for Sexual Health focused on measuring sexual health, Autism Spectrum Disorders
Eligibility 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
Sites / Locations
- Public Health Management CorporationRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Program+survey
Survey-only
Arm Description
Outcomes
Primary Outcome Measures
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).
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).
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)
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
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
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
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.
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.
Secondary Outcome Measures
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
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
Full Information
NCT ID
NCT04005547
First Posted
April 13, 2018
Last Updated
June 28, 2019
Sponsor
Public Health Management Corporation
Collaborators
Temple University
1. Study Identification
Unique Protocol Identification Number
NCT04005547
Brief Title
Health Education and Relationships Through Theater: An RCT of Promoting Awareness Through Live Movement and Sound for Youth With Autism Spectrum Disorder (PALMS-ASD)
Acronym
HEART
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)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 15, 2017 (Actual)
Primary Completion Date
February 2021 (Anticipated)
Study Completion Date
February 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Public Health Management Corporation
Collaborators
Temple University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sexual Health, Education, Health
Keywords
sexual health, Autism Spectrum Disorders
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
250 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Program+survey
Arm Type
Experimental
Arm Title
Survey-only
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Promoting Awareness through Live Movement and Sound for youth with Autism Spectrum Disorder
Other Intervention Name(s)
PALMS-ASD
Intervention Description
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
Primary Outcome Measure Information:
Title
unsafe sex self-report survey item
Description
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).
Time Frame
6 months
Title
unsafe sex self-report survey item
Description
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).
Time Frame
12 months
Title
sexual health knowledge self-report survey scale
Description
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
Title
adult-teen communication youth-report survey scale
Description
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
Title
sexual health empowerment self-report survey scale
Description
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
Title
sexual health empowerment self-report survey scale
Description
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
Title
self-protective boundary knowledge self-report survey scale
Description
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
Title
self-protective boundary knowledge self-report survey scale
Description
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 Outcome Measure Information:
Title
sexual health efficacy self-report survey, item or scale
Description
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
Title
sexual health efficacy self-report survey, item or scale
Description
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 Pre-specified Outcome Measures:
Title
reasons for singleness
Description
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.
Time Frame
6 months
Title
reasons for singleness
Description
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.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Public Health Management Corporation
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19102
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Project Manager
Phone
215-731-2027
Email
heartstudy@phmc.org
First Name & Middle Initial & Last Name & Degree
Katharine T Hemady, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Health Education and Relationships Through Theater: An RCT of Promoting Awareness Through Live Movement and Sound for Youth With Autism Spectrum Disorder (PALMS-ASD)
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