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Evaluation of Practice Self-Regulation (PS-R)

17 febbraio 2021 aggiornato da: The Policy & Research Group

Evaluation of Practice Self-Regulation (PS-R)

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.

Panoramica dello studio

Descrizione dettagliata

The Policy & Research Group (PRG) will be evaluating the Practice Self-Regulation (PSR) program. This intervention is designed to address gaps in the existing evidence, reduce disparities in teen pregnancy and associated sexual and reproductive health outcomes, and serve high-need populations. The intervention is composed of ten structured, individual therapy sessions intended to promote optimal sexual decision making. By increasing knowledge of sexual health and the impact of trauma on sexual decision-making, youth are encouraged and supported in practicing self-regulation. The primary focus of the study will be to investigate the impact of the intervention on participants' self-reported sexual behaviors (times having sex with no condom and number of sexual partners). In addition, the study will include exploratory investigations of the following theoretically relevant antecedents to behavior and pathways to behavior change: (1) perception of risk and severity for pregnancy and HIV/STIs; (2) intention to have sex; (3) importance of having sex; (4) intention to use effective contraceptive methods (including condoms); (5) affect regulation self-efficacy; (6) importance of using effective contraceptive methods; (7) intention to limit number of sexual partners; (8) importance to limiting the number of sexual partners; (9) intention to practice affect regulation; (10) self-esteem; (11) importance of using affect regulation; (12) intention to practice sexual self-regulation; (13) importance of practicing sexual self-regulation; (14) contraceptive use and negotiation (including condoms) self-efficacy; (15) sexual activity decision making and planning self-efficacy; (16) beliefs regarding the malleability of emotions; (17) beliefs regarding value of affect regulation; (18) use of effect regulation; and (19) distress . The control (counterfactual) condition, Therapy Practice Group, consists of therapy as usual without the incorporation of elements vital to the PSR intervention. All eligible individuals who provide the proper consent to participate are randomized and enrolled into the study at the time they attend their first scheduled study session. Outcomes will be assessed using self-reported, participant-level data gathered (by way of a questionnaire) at three time points: baseline (enrollment); post-program (immediately after the end of the intervention period, which is 18 weeks after baseline); and 9-month follow-up (9 months following the end of the intervention period, which is 13 months after baseline). The study is taking place in California, Louisiana, New Mexico, Michigan, and Maine. Recruitment of study participants and delivery of the intervention is conducted by trained private practitioners and therapists working at participating agencies who are serving youth between the ages of 14 and 19 and are receiving outpatient mental health services.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

432

Fase

  • Non applicabile

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 14 anni a 19 anni (Bambino, Adulto)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
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.
Comparatore attivo: 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.
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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of sexual partners
Lasso di tempo: 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.
9 months after the end of the intervention
Times having sex without a condom
Lasso di tempo: 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.
9 months after the end of the intervention

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: Eric Jenner, PhD, MMC, BA, The Policy & Research Group

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 giugno 2016

Completamento primario (Effettivo)

27 agosto 2020

Completamento dello studio (Effettivo)

27 agosto 2020

Date di iscrizione allo studio

Primo inviato

3 novembre 2016

Primo inviato che soddisfa i criteri di controllo qualità

3 novembre 2016

Primo Inserito (Stima)

8 novembre 2016

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

18 febbraio 2021

Ultimo aggiornamento inviato che soddisfa i criteri QC

17 febbraio 2021

Ultimo verificato

1 febbraio 2021

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • 5 TP1AH000003-02-00 PS-R

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

Descrizione del piano IPD

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.

Periodo di condivisione IPD

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

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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