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

NCT ID: NCT04005547

Last Updated: 2023-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-15

Study Completion Date

2020-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Sexual Health Education, Health

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Program+survey

Group Type EXPERIMENTAL

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

Intervention Type BEHAVIORAL

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

Survey-only

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

PALMS-ASD

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

14 Years

Maximum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Temple University

OTHER

Sponsor Role collaborator

Public Health Management Corporation

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Public Health Management Corporation

Philadelphia, Pennsylvania, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

90AP2690-01-00

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

PublicHMC

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.