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En randomisert kontrollert studie for å evaluere et traumeinformert partnervoldsinngrepsprogram

29. september 2026 oppdatert av: Boston University

The goal of this study is to conduct a randomized controlled trial (RCT) comparing outcomes between two programs to reduce intimate partner violence (IPV)- the Strength at Home (SAH) program and a standard, state-approved IPV intervention program, Treatment as Usual (TAU). Primary outcomes will include self- and partner-reported physical and psychological IPV. Secondary outcomes will include self-reported PTSD symptoms, alexithymia, alcohol use problems, and treatment satisfaction, assessed across five time points.

Studieoversikt

Status

Påmelding etter invitasjon

Detaljert beskrivelse

A mixed-methods approach will be used for this single site, parallel group RCT. All participants will be randomized at the individual level to Strength at Home (SAH) or Treatment as Usual (TAU), with a 1:1 allocation ratio. Assessments will occur pre-treatment and post-treatment with follow-up assessments scheduled every three months post-treatment through month 12. Assessments have been designed to examine reductions in IPV and other outcomes including posttraumatic stress disorder (PTSD) symptoms and alcohol use.

The primary hypotheses are that those receiving SAH will evidence greater reductions in physical and psychological IPV, symptoms of PTSD, alexithymia, and alcohol use problems, and higher treatment satisfaction relative to those receiving TAU across the time points.

The specific aims and sub aims are:

  1. Test the comparative effectiveness of SAH and TAU by conducting an RCT comparing 200 justice-involved men randomly assigned to each program.

    • Compare the frequency of physical and psychological IPV, the primary outcomes of interest, across conditions as reported by the male participants and their intimate partners across Time 1 (baseline) and four 3-month follow ups (Times 2-5). Additionally, at Time 5, the study may make use of available arrest record data from the state of Rhode Island.
    • Compare symptoms of PTSD, alexithymia, and alcohol use problems across conditions and assessment time points as reported by the male participants.
    • Compare treatment satisfaction across conditions as reported by the male participants across the four 3-month follow ups (Times 2-5).
  2. Facilitate future use of SAH by working closely with the Stakeholder Advisory Board to identify potential barriers and facilitators to successful implementation in civilian community settings.

    • Identify barriers and facilitators to implementation.
    • Assess the acceptability of SAH among stakeholders in the community setting and areas in need of refinement.

Studietype

Intervensjonell

Registrering (Antatt)

1000

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • Massachusetts
      • Boston, Massachusetts, Forente stater, 02118
        • BU Chobanian & Avedisian School of Medicine, Psychiatry

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Mann

Beskrivelse

Inclusion Criteria:

  • Men court-mandated to IPV intervention from the Rhode Island Department of Parole and Probation and their partners

Exclusion Criteria:

  • None

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Strength at Home (SAH)

SAH isa trauma-informed 12-week intimate partner violence (IPV) intervention program.

SAH is a group trauma informed intervention that uses motivational strategies and self-monitoring of one's thoughts and responses. It provides a unique fusion of interventions for trauma and IPV and consists of 12 two-hour weekly sessions. Throughout the program, group members complete in-session practice exercises and are provided "practice assignments" to consolidate and apply information learned in group.

Aktiv komparator: Treatment as Usual (TAU)

TAU is a 20-week state-approved IPV intervention program.

TAU is a court mandated 20 week, psychoeducational/directed program that emphasizes the sharing of power and control in relationships and personal accountability. Topics also focus on equality wheels, substance abuse impacts, culture and socialization impact on gender roles, defense mechanisms versus coping skills, triggers for stress and anger, and healthy versus unhealthy communication.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
IPV Assessment
Tidsramme: Baseline, 3 months, 6 months, 9 months, 12 months

The Revised Conflict Tactics Scale (CTS2) is a 39-item measure of individual engagement in or experience of physical or psychological violence with an intimate partner. Each item is asked about both the respondent and the respondent's partner, for a total of 78 questions.The response options include 8 choices (Categories 1-7 and 0). An answer of Category 1 or 2 is coded as the corresponding number of times the specified incident occurred (once or twice in the past year). For Categories 3-5, the midpoint of the category is coded. For example: Category 3 (3-5 times) is coded as 4, Category 4 (6-10 times) is coded as 8, and Category 5 (11-20 times) is coded as 15. Category 6 (More than 20 times) should be coded as 25. Category 7 is given a score of 0 if scores for the previous year do not reflect abuse or conflict. Total scores can range from 0 to 975 and lower scores suggest less conflict.

Baseline, 3 months, 6 months, 9 months, 12 months
Psychological IPV Assessment
Tidsramme: Baseline, 3 months, 6 months, 9 months, 12 months

The 7-item Restrictive Engulfment subscale of the Multidimensional Measure of Emotional Abuse (MMEA) will be used as an additional measure of psychological IPV. Each item has 7 potential responses from 0=never to 6= more than 20 times. Scores can range from 0 to 42, with higher scores being associated with more psychological IPV.

Baseline, 3 months, 6 months, 9 months, 12 months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Post traumatic stress disorder (PTSD)
Tidsramme: Baseline, 3 months, 6 months, 9 months, 12 months

The 20-item PTSD Checklist for DSM 5 (PCL-5) will be used to assess PTSD symptoms. It is a self-report measure. Items are rated on a 5-point Likert scale [0 to 4] and summed. Scores range from 0 to 80 with higher scores associated with more PTSD symptoms. A total score of 33 or higher may indicate severe PTSD.

Baseline, 3 months, 6 months, 9 months, 12 months
Alexithymia
Tidsramme: Baseline, 3 months, 6 months, 9 months, 12 months

The 20-itemToronto Alexithymia Scale (TAS-20) will be used to assess alexithymia. The TAS-20 uses cutoff scoring, with scores of 52-60 indicating possible alexithymia, and scores above 60 indicating alexithymia.

Baseline, 3 months, 6 months, 9 months, 12 months
Alcohol Use
Tidsramme: Baseline, 3 months, 6 months, 9 months, 12 months

Alcohol use will be assessed by the Alcohol Use Disorders Identification Test (AUDIT). AUDIT has 10 questions and the possible responses to each question are scored 0, 1, 2, 3 or 4, with the exception of questions 9 and 10 which have possible responses of 0, 2 and 4. The range of possible scores is from 0 to 40 where 0 indicates an abstainer who has never had any problems from alcohol.

Baseline, 3 months, 6 months, 9 months, 12 months
Treatment satisfaction
Tidsramme: 3 months, 6 months, 9 months, 12 months

Participants' satisfaction will be assessed with a 4-item measure used in a study conducted by the Treatment of Depression Collaborative Research Program.

3 months, 6 months, 9 months, 12 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: Casey T Taft, PhD, BU Chobanian & Avedisian School of Medicine, Psychiatry

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

13. februar 2025

Primær fullføring (Antatt)

1. desember 2028

Studiet fullført (Antatt)

1. desember 2028

Datoer for studieregistrering

Først innsendt

27. januar 2025

Først innsendt som oppfylte QC-kriteriene

27. januar 2025

Først lagt ut (Faktiske)

31. januar 2025

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

1. oktober 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

29. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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