- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02957669
Evaluation of Practice Self-Regulation (PS-R)
17. februar 2021 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
432
Fase
- Ikke anvendelig
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
14 år til 19 år (Barn, Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: 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.
|
Aktiv komparator: 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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Number of sexual partners
Tidsramme: 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
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Eric Jenner, PhD, MMC, BA, The Policy & Research Group
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Hjælpsomme links
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. juni 2016
Primær færdiggørelse (Faktiske)
27. august 2020
Studieafslutning (Faktiske)
27. august 2020
Datoer for studieregistrering
Først indsendt
3. november 2016
Først indsendt, der opfyldte QC-kriterier
3. november 2016
Først opslået (Skøn)
8. november 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
18. februar 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
17. februar 2021
Sidst verificeret
1. februar 2021
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 5 TP1AH000003-02-00 PS-R
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
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.
IPD-delingstidsramme
The individual participant dataset will become available twelve months after the study has concluded.
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Forebyggelse af teenagegraviditet
-
Children's Hospital of PhiladelphiaUniversity of PennsylvaniaAfsluttet
-
Winter Rose Services, LLCDepartment of Health and Human ServicesUkendt
-
Eunice Kennedy Shriver National Institute of Child...AfsluttetTeen graviditetForenede Stater
-
Philliber Research & EvaluationThe Office of Adolescent Health, HHS; Planned Parenthood of the Great Northwest...AfsluttetTeen graviditet | STD forebyggelseForenede Stater
-
Children's Hospital Los AngelesETR AssociatesRekruttering
-
Philliber Research & EvaluationThe Office of Adolescent Health, HHSUkendt
-
The University of Texas Health Science Center at...The Office of Adolescent Health, HHSAfsluttet
-
Children's Hospital of PhiladelphiaUniversity of PennsylvaniaAfsluttetTeen-chauffører | MotorkøretøjsulykkerForenede Stater
-
Abt AssociatesDepartment of Health and Human Services; Decision Information Resources...AfsluttetTeen graviditet | Seksuel risikotagningsadfærd
-
Centers for Disease Control and PreventionBaltimore City Health Department; NORC at the University of Chicago; Ogilvy... og andre samarbejdspartnereAfsluttetTeen Dating Vold | Sund datingforholdForenede Stater
Kliniske forsøg med Practice Self-Regulation
-
Icahn School of Medicine at Mount SinaiNational Institute on Disability, Independent Living, and Rehabilitation...AfsluttetTraumatisk hjerneskade | Executive dysfunktion | Følelsesdysregulering | FølelsesdysfunktionForenede Stater
-
Douglas MenninWeill Medical College of Cornell University; Kent State UniversityAfsluttetGeneraliseret angstlidelse | Depression, angst | Angstlidelser og symptomer | Følelsesmæssig dysfunktionForenede Stater
-
University of MiamiUniversity of Kansas; American Music Therapy AssociationAfsluttet
-
Karolinska InstitutetAfsluttetBorderline personlighedsforstyrrelse | Ikke-suicidal selvskade (NSSI)Sverige
-
Massachusetts General HospitalNational Institute of Mental Health (NIMH)RekrutteringTvangslidelse | Generaliseret angstlidelse | Større depressiv lidelseForenede Stater
-
British University In EgyptAfsluttetAngst | FølelsesreguleringEgypten
-
University of BergenHaukeland University HospitalRekrutteringAttention Deficit Hyperactivity DisorderNorge
-
Kessler FoundationTilmelding efter invitationMultipel sclerose | Følelsesmæssige forstyrrelserForenede Stater
-
Rhode Island HospitalEunice Kennedy Shriver National Institute of Child Health and Human Development...AfsluttetRisikoadfærd | Risikoreduktion | FølelsesreguleringForenede Stater
-
Erasmus University RotterdamRekrutteringStress | Angst | Depressive symptomer | Modstandsdygtighed | FølelsesreguleringHolland