NCT02957669

Brief Summary

The purpose of the study is to determine the impact of the offer to participate in the Practice Self-Regulation (PS-R) (treatment) relative to the offer to participate in the Therapy Practice Group (control) on participants' reported number of sexual partners and reported number of times having sex without a condom nine months after the end of treatment.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
432

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2016

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 3, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 8, 2016

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 27, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 27, 2020

Completed
Last Updated

February 18, 2021

Status Verified

February 1, 2021

Enrollment Period

4.2 years

First QC Date

November 3, 2016

Last Update Submit

February 17, 2021

Conditions

Teen Pregnancy Prevention

Outcome Measures

Primary Outcomes (2)

  • Number of sexual partners

    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.

    9 months after the end of the intervention

  • Times having sex without a condom

    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.

    9 months after the end of the intervention

Study Arms (2)

Practice Self-Regulation (PS-R)

EXPERIMENTAL

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

Therapy Practice Group

ACTIVE COMPARATOR

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

Interventions

Practice Self-RegulationBEHAVIORAL

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.

Practice Self-Regulation (PS-R)
Therapy Practice GroupBEHAVIORAL

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.

Therapy Practice Group

Eligibility Criteria

Age14 Years - 19 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Between the ages of 14-19
  • Provide parental consent (if under age 18) and participant assent to participate in the study
  • Deemed appropriate for the study by the agency staff
  • Receiving individual outpatient counseling services at one of the study's implementation sites

You may not qualify if:

  • Previous participation in the study
  • Previous use of the Trauma Outcome Process (TOP) workbook in therapy
  • Self-report of previous participation in other TPP-funded programs
  • Self-report of roommate who participated in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

Study Officials

  • Eric Jenner, PhD, MMC, BA

    The Policy & Research Group

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 2016

First Posted

November 8, 2016

Study Start

June 1, 2016

Primary Completion

August 27, 2020

Study Completion

August 27, 2020

Last Updated

February 18, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will share

A dataset will be prepared at the conclusion of the study, which includes de-identified individual-level data on all study participants who contributed self-report data. Respondents will be represented only by a research ID number. Included in the dataset will be self-report data collected across all survey administrations (including demographic characteristics, sexual behaviors, and theoretical antecedents to those behaviors) and select information on program participation (e.g., which program sessions were attended). Basic data cleaning steps will be taken in order to ensure data are unidentifiable and to increase usability.

Time Frame
The individual participant dataset will become available twelve months after the study has concluded.