Evaluation of Practice Self-Regulation (PS-R)
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|ClinicalTrials.gov Identifier: NCT02957669|
Recruitment Status : Active, not recruiting
First Posted : November 8, 2016
Last Update Posted : May 7, 2019
|Condition or disease||Intervention/treatment||Phase|
|Teen Pregnancy Prevention||Behavioral: Practice Self-Regulation Behavioral: Therapy Practice Group||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||432 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of Practice Self-Regulation (PS-R)|
|Actual Study Start Date :||July 2016|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||June 2020|
Experimental: Practice Self-Regulation (PS-R)
Practice Self-Regulation (PS-R) is the treatment condition. PS-R is an in-person, individual-level, clinic-based intervention that aims to increase knowledge of sexual health and the impact of trauma on sexual decision-making.
Behavioral: Practice Self-Regulation
PS-R is an in-person, individual-level, clinic-based intervention implemented by mental health professionals trained in the intervention. It is intended to be implemented in ten structured, individual therapy sessions lasting approximately 50 minutes over the course of 18 weeks.
Active Comparator: Therapy Practice Group
Therapy Practice Group is the control counterfactual condition. It is an individual-level, therapy as usual in which the therapist addresses mental health concerns of the participant.
Behavioral: Therapy Practice Group
Therapy Practice Group is the control condition aimed at providing the youth a safe space to work on meeting their mental health goals. It is intended to be at least ten sessions over the course of 18 weeks.
- Number of sexual partners [ Time Frame: 9 months after the end of the intervention ]Participant self-report of the number of sexual partners in the past three months. Measured through two survey questions which ask the participant with whom they have had sexual contact during their life, and if sexual contact with any gender is reported are subsequently asked how many sexual partners they have had in the past three months.
- Times having sex without a condom [ Time Frame: 9 months after the end of the intervention ]Participant self-report on the number of times they have had vaginal, oral, or anal sex without a condom in the last three months. Measured through three survey questions which ask the participant how many times they have had vaginal, oral, and anal sex in the past three months.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02957669
|Principal Investigator:||Eric Jenner, PhD, MMC, BA||The Policy & Research Group|