Trial Outcomes & Findings for First CRUSH: Piloting the Preliminary Feasibility and Acceptability of the Competence in Romance and Understanding Sexual Health (CRUSH) Curriculum (NCT NCT05910658)

NCT ID: NCT05910658

Last Updated: 2026-08-13

Results Overview

A qualitative measure of the acceptability of intervention was collected at each timepoint. Quantitative acceptability ratings about the CRUSH curriculum were obtained at the conclusion of intervention using a 5-point rating scale, with "1" indicating agreement with a statement about the curriculum and "5" indicating disagreement. Items were: I would be likely to recommend the program to a friend. Knowing what I know now, I'm happy with my choice to participate in the CRUSH Program. The program was easy to understand. The CRUSH Program presented information clearly. The program was relevant to me and my experience. The program was helpful. I learned new information from the program. I feel more confident in my ability try new things in relationships or sexual experiences after participating in the program. I have new skills/behaviors after participating in the program. Items were averaged into a total score (range: 1-5); lower scores reflected higher agreement/better acceptability.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

8 participants

Primary outcome timeframe

At baseline enrollment visit and weekly throughout training for a total of 20 weeks

Results posted on

2026-08-13

Participant Flow

Participant milestones

Participant milestones
Measure
Intervention Group
Participants will receive the CRUSH Curriculum Competence in Romance and Understanding Sexual Health (CRUSH): Manualized curriculum targeting sexual health and behavior in intimate relationships designed to meet the specific needs of autistic adults
Overall Study
STARTED
8
Overall Study
COMPLETED
8
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

First CRUSH: Piloting the Preliminary Feasibility and Acceptability of the Competence in Romance and Understanding Sexual Health (CRUSH) Curriculum

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Intervention Group
n=8 Participants
Participants will receive the CRUSH Curriculum Competence in Romance and Understanding Sexual Health (CRUSH): Manualized curriculum targeting sexual health and behavior in intimate relationships designed to meet the specific needs of autistic adults
Age, Customized
18-24 years
4 Participants
n=1 Participants
Age, Customized
25-30
4 Participants
n=1 Participants
Sex: Female, Male
Female
3 Participants
n=1 Participants
Sex: Female, Male
Male
5 Participants
n=1 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=1 Participants
Race (NIH/OMB)
Asian
1 Participants
n=1 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=1 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=1 Participants
Race (NIH/OMB)
White
4 Participants
n=1 Participants
Race (NIH/OMB)
More than one race
3 Participants
n=1 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=1 Participants
Region of Enrollment
United States
8 participants
n=1 Participants

PRIMARY outcome

Timeframe: At baseline enrollment visit and weekly throughout training for a total of 20 weeks

A qualitative measure of the acceptability of intervention was collected at each timepoint. Quantitative acceptability ratings about the CRUSH curriculum were obtained at the conclusion of intervention using a 5-point rating scale, with "1" indicating agreement with a statement about the curriculum and "5" indicating disagreement. Items were: I would be likely to recommend the program to a friend. Knowing what I know now, I'm happy with my choice to participate in the CRUSH Program. The program was easy to understand. The CRUSH Program presented information clearly. The program was relevant to me and my experience. The program was helpful. I learned new information from the program. I feel more confident in my ability try new things in relationships or sexual experiences after participating in the program. I have new skills/behaviors after participating in the program. Items were averaged into a total score (range: 1-5); lower scores reflected higher agreement/better acceptability.

Outcome measures

Outcome measures
Measure
Intervention Group
n=8 Participants
Participants will receive the CRUSH Curriculum
Acceptability Rating Scale
1.301886792 Units on a 5-point rating scale
Standard Deviation 0.503255007

SECONDARY outcome

Timeframe: At baseline enrollment visit and weekly throughout training for a total of 20 weeks

Analysis of missing items or session content that cannot be completed (fewer missing items indicates better feasibility)

Outcome measures

Outcome measures
Measure
Intervention Group
n=8 Participants
Participants will receive the CRUSH Curriculum
Feasibility Assessment
8 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: At baseline enrollment visit; 8-10 weeks after beginning intervention (i.e., midpoint); 18-22 weeks after beginning intervention (i.e., post-testing). Effect sizes are for change across timepoints (i.e., trajectory from baseline to midpoint to post).

A measure of 18 terms related to basic knowledge of sexual health and anatomy. The Vocabulary Accuracy score measures the ability to provide definitions of sexual health terms (knowledge) and is scored on a 3-point scale for accuracy: 2 for a detailed correct answer, 1 for a generally correct answer, and 0 for a response of "don't know" or an incorrect answer. The Pragmatics score measures sociocultural competence (slang), vulgarity, mechanical language, relevancy, strategic competence, and discourse competence. Pragmatics are scored scored on a scale of 0-2 with 0 representing the highest level of pragmatic skill and 2 represented the lowest score for each item. This test was used as a measure of target engagement. Partial eta squared effect size is for change over time (baseline, midpoint, post) modeled with repeated measures ANOVA.

Outcome measures

Outcome measures
Measure
Intervention Group
n=7 Participants
Participants will receive the CRUSH Curriculum
Sexual Vocabulary Test (Ousley & Mesibov, 1991; Kohn et al., 2022) - Vocabulary Accuracy and Pragmatics Scores
Pragmatic (slang)
0.43 Partial eta squared (effect size)
Sexual Vocabulary Test (Ousley & Mesibov, 1991; Kohn et al., 2022) - Vocabulary Accuracy and Pragmatics Scores
Accuracy (knowledge)
0.15 Partial eta squared (effect size)

OTHER_PRE_SPECIFIED outcome

Timeframe: At baseline enrollment visit; 8-10 weeks after beginning intervention (i.e., midpoint); 18-22 weeks after beginning intervention (i.e., post-testing). Effect sizes are for change across timepoints (i.e., trajectory from baseline to midpoint to post).

A measure of sexual health and intimate behavior to be used as a primary outcome in a future trial (higher scores indicate higher levels of behavior) measures possible outcomes of sexuality education programs including changes in behavior that facilitate a positive and fulfilling sexuality and sexual health and independent of relationship status. It includes 45 items that include the skill with which a behavior is completed, comfort during that behavior, and the frequency of the behavior; responses use a 5-point rating, a 4-point rating, and the frequency in the past month, respectively. Partial eta squared effect size is for change over time (baseline, midpoint, post) modeled with repeated measures ANOVA.

Outcome measures

Outcome measures
Measure
Intervention Group
n=8 Participants
Participants will receive the CRUSH Curriculum
Mathtech Behavioral Scale (Kirby, 2013)
Comfort having Current Sex Life (whatever it may be)
0.16 Partial eta squared (effect size)
Mathtech Behavioral Scale (Kirby, 2013)
Comfort Getting and Using Birth Control
0.15 Partial eta squared (effect size)
Mathtech Behavioral Scale (Kirby, 2013)
Comfort with being Sexually Assertive (more confidence saying "no")
0.13 Partial eta squared (effect size)
Mathtech Behavioral Scale (Kirby, 2013)
Sexual Decision-Making Skills (more efficient and collaborative sexual health decision making)
0.06 Partial eta squared (effect size)
Mathtech Behavioral Scale (Kirby, 2013)
Comfort Talking about Birth Control (with friends, partners, parents)
.222 Partial eta squared (effect size)

Adverse Events

Intervention Group

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Susan Faja

Boston Children's Hospital / Harvard Medical School

Phone: 6179194486

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place