- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07816445
Pilot Study of an Interparental Conflict Intervention for Separating or Divorcing Parents
Pilot Study to Test Effects of a New Interparental Conflict Intervention for Separating or Divorcing Parents
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
This study is a randomized pilot trial of a new, scalable intervention for separating or divorcing parents experiencing interparental conflict. The intervention was developed by adapting components of existing evidence-based interventions using human-centered design methods. The intervention is designed to teach parents skills for reducing children's exposure to interparental conflict and protecting children's mental health and well-being.
Approximately 94 parents who are court ordered to participate in an intervention addressing interparental conflict will be randomly assigned to either the new intervention or an existing court-based program. The new intervention is expected to include an orientation session followed by three or four digital sessions. The pilot study will evaluate implementation outcomes, including feasibility, acceptability, appropriateness, and usability, as well as preliminary effects on interparental conflict and children's internalizing and externalizing problems. The study will also examine parents' use of skills intended to protect children from interparental conflict and interpersonal violence and parents' emotion-regulation skills.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Sharlene A Wolchik, PhD
- E-post: wolchik@asu.edu
Studera Kontakt Backup
- Namn: Karey L O'Hara, PhD
- Telefonnummer: 480-727-6136
- E-post: klohara@asu.edu
Studieorter
-
-
Arizona
-
Tempe, Arizona, Förenta staterna, 85287
- Rekrytering
- Arizona State University
-
Kontakt:
- Karey L O'Hara, PhD
- Telefonnummer: 480-727-3623
- E-post: klohara@asu.edu
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
Inclusion Criteria:
- Age 18 years or older
- Fluent in English
- Court ordered to attend an intervention to reduce interparental conflict
Exclusion Criteria: None
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Family COMPASS
Participants receive Family COMPASS, a four-session parenting intervention for parents experiencing high levels of interparental conflict following separation or divorce.
|
Family COMPASS (Conflict Management through Purposeful Awareness, Strategies, and Support) is a manualized, trauma-informed parenting intervention designed to reduce children's exposure to interparental conflict following parental separation or divorce.
The intervention consists of four highly structured, approximately 30-minute sessions delivered virtually or in person by trained personnel.
It focuses on strengthening parents' emotion regulation, communication, co-parenting, conflict management, and safety planning skills.
|
|
Aktiv komparator: Families in Transition (FIT)
Participants receive FIT, an existing 90-minute online parent education program designed to help separating or divorcing parents reduce interparental conflict and children's exposure to conflict.
|
FIT is a 90-minute online parent education program developed by the Superior Court of Maricopa County in collaboration with the National Center for State Courts.
The program includes four modules, a film, and interactive activities.
It validates parents' difficult feelings toward their co-parent while emphasizing behavior change to protect children from interparental conflict.
Content addresses the effects of interparental conflict on children, prioritizing children's needs, developing a child-focused vision for the future, and using practical strategies to reduce conflict behaviors.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Child Anxiety Symptoms
Tidsram: Baseline and 30 days after program completion
|
Parent-reported child anxiety symptoms assessed using the Anxiety subscale of the Revised Child Anxiety and Depression Scale-25 Parent Version (RCADS-25-P).
The Anxiety subscale contains 15 items rated from 0 (Never) to 3 (Always).
Raw scores range from 0 to 45, with higher scores indicating greater anxiety symptoms.
|
Baseline and 30 days after program completion
|
|
Child Depressive Symptoms
Tidsram: Baseline and 30 days after program completion
|
Parent-reported child depressive symptoms assessed using the Depression subscale of the Revised Child Anxiety and Depression Scale-25 Parent Version (RCADS-25-P).
The Depression subscale contains 10 items rated from 0 (Never) to 3 (Always).
Raw scores range from 0 to 30, with higher scores indicating greater depressive symptoms.
|
Baseline and 30 days after program completion
|
|
Child Irritability/Anger
Tidsram: Baseline and 30 days after program completion
|
Parent-reported child irritability and anger assessed using the irritability/anger item of the DSM-5 Level 1 Cross-Cutting Symptom Measure-Parent/Guardian-Rated Measure for Children Ages 6-17.
The item is rated from 0 (Not at all) to 4 (Nearly every day).
Scores range from 0 to 4, with higher scores indicating greater irritability/anger.
|
Baseline and 30 days after program completion
|
|
Child Attention Problems
Tidsram: Baseline and 30 days after program completion
|
Parent-reported child attention problems assessed using the attention item of the DSM-5 Level 1 Cross-Cutting Symptom Measure-Parent/Guardian-Rated Measure for Children Ages 6-17.
The item is rated from 0 (Not at all) to 4 (Nearly every day).
Scores range from 0 to 4, with higher scores indicating greater attention problems.
|
Baseline and 30 days after program completion
|
|
Interparental Conflict
Tidsram: Baseline and 30 days after program completion
|
Parent-reported interparental conflict assessed using the 13-item intensity and frequency subscales of the Children's Perception of Interparental Conflict Scale, adapted for parent report.
Items are rated on a 3-point scale and appropriately reverse-scored.
Using summed item scores coded from 0 to 2, total scores range from 0 to 26, with higher scores indicating greater interparental conflict.
|
Baseline and 30 days after program completion
|
|
Intervention Feasibility
Tidsram: Approximately 30 days after program completion
|
Parent-reported feasibility assessed using the 4-item Feasibility of Intervention Measure (FIM).
Items are rated from 1 (Completely disagree) to 5 (Completely agree), with scores ranging from 4 to 20.
Higher scores indicate greater perceived feasibility.
|
Approximately 30 days after program completion
|
|
Intervention Acceptability
Tidsram: Approximately 30 days after program completion
|
Parent-reported acceptability assessed using the 4-item Acceptability of Intervention Measure (AIM).
Items are rated from 1 (Completely disagree) to 5 (Completely agree), with scores ranging from 4 to 20.
Higher scores indicate greater acceptability.
|
Approximately 30 days after program completion
|
|
Intervention Appropriateness
Tidsram: Approximately 30 days after program completion
|
Parent-reported appropriateness assessed using the 4-item Intervention Appropriateness Measure (IAM).
Items are rated from 1 (Completely disagree) to 5 (Completely agree), with scores ranging from 4 to 20.
Higher scores indicate greater perceived appropriateness.
|
Approximately 30 days after program completion
|
|
Intervention Usability
Tidsram: Approximately 30 days after program completion
|
Parent-reported intervention usability assessed using the 10-item Intervention Usability Scale (IUS).
Items are rated on a 5-point agreement scale.
Positively and negatively worded items are scored according to standard IUS scoring procedures, and the summed score is multiplied by 2.5.
Total scores range from 0 to 100, with higher scores indicating greater perceived intervention usability.
|
Approximately 30 days after program completion
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Emotion Regulation Difficulties
Tidsram: Baseline and 30 days after program completion
|
Parent-reported difficulties in emotion regulation assessed using the 16-item Difficulties in Emotion Regulation Scale-Short Form (DERS-SF).
Items are rated from 1 (Almost Never) to 5 (Almost Always), with total scores ranging from 16 to 80. Higher scores indicate greater difficulties with emotion regulation.
|
Baseline and 30 days after program completion
|
|
Confidence in Making a Safety Plan for Self
Tidsram: Baseline and 30 days after program completion
|
Parent-reported confidence in the ability to make a safety plan for oneself, assessed using a single-item rating scale ranging from 0 (Not at all confident) to 100 (Completely confident).
Higher scores indicate greater confidence in safety planning.
|
Baseline and 30 days after program completion
|
|
Confidence in Making a Safety Plan for Children
Tidsram: Baseline and 30 days after program completion
|
Parent-reported confidence in the ability to make a safety plan for one's child or children, assessed using a single-item rating scale ranging from 0 (Not at all confident) to 100 (Completely confident).
Higher scores indicate greater confidence in safety planning.
|
Baseline and 30 days after program completion
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- STUDY00015304
- R34MH126052 (U.S.S. NIH-anslag/kontrakt)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .