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N/A N=276 Randomized Prevention

Randomized Controlled Trial of Prenatal Coparenting Intervention (CoparentRCT)

Parenting

Enrolled (actual)
276
Serious AEs
9.8%
Results posted
Dec 2022
Primary outcome: Primary: System for Coding Interactions in Dyads (SCID) Positive Communication Patterns — 2.46; 2.53; 2.25; 2.15 score on a scale — p=.32

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Focused Coparenting Consultation (Behavioral)
Age
Pediatric, Adult · 14+ yrs
Sex
All
Sponsor
University of South Florida
Primary completion
Dec 2021

Outcome Measures

OutcomeResultp-value
PRIMARY
System for Coding Interactions in Dyads (SCID) Positive Communication Patterns
2.46; 2.53; 2.05; 1.99 .22
PRIMARY
System for Coding Interactions in Dyads (SCID) Negative Communication Patterns
1.80; 1.85; 1.78; 1.91 .33
PRIMARY
System for Coding Interactions in Dyads (SCID) Positive Communication Patterns
2.46; 2.53; 2.05; 1.99 .22
PRIMARY
System for Coding Interactions in Dyads (SCID) Negative Communication Patterns
1.80; 1.85; 1.78; 1.91 .33
PRIMARY
Coparenting and Family Rating Scale (CFRS) Coparent Solidarity/Family Harmony
1.49; 1.32 .56
PRIMARY
Coparenting and Family Rating Scale (CFRS) Coparent Negativity/Hostility & Competitiveness
0.90; 0.90 .85
PRIMARY
Coparenting and Family Rating Scale (CFRS) Coparent Solidarity/Family Harmony
1.49; 1.32 .56
PRIMARY
Coparenting and Family Rating Scale (CFRS) Coparent Negativity/Hostility & Competitiveness
0.90; 0.90 .85
PRIMARY
Perceived Coparenting Solidarity as Measured by Parenting Alliance Measure (PAM) Communication Subscale
71.58; 72.79; 68.81; 72.50; 64.78; 65.52 <.001 sig
PRIMARY
Perceived Coparenting Solidarity as Measured by Parenting Alliance Measure (PAM) Respect Subscale
13.38; 13.40; 12.67; 12.85; 11.67; 11.63 <.05 sig
PRIMARY
Intimate Partner Violence as Assessed by the Psychological Aggression Scale of the Revised-Conflict Tactics Scale (CTS2; Straus et al., 1996).
11.91; 14.51; 20.21; 15.17; 12.26; 6.91 .39
PRIMARY
Infant Socio-emotional Competencies as Assessed by the Negative Emotionality Scale of the Infant Toddler Social Emotional Assessment (ITSEA; Carter & Briggs-Gowan, 2006)
6.83; 7.14; 8.73; 8.28 .24
PRIMARY
Infant Socio-emotional Competencies as Assessed by the Aggression Scale of the Infant Toddler Social Emotional Assessment (ITSEA; Carter & Briggs-Gowan, 2006)
12.00; 18.00; 17.00; 14.00 .02 sig
PRIMARY
Infant Socio-emotional Competencies as Assessed by the Compliance Scale of the Infant Toddler Social Emotional Assessment (ITSEA; Carter & Briggs-Gowan, 2006)
9.00; 8.63; 8.53; 9.06 .30
PRIMARY
Infant Socio-emotional Competencies as Assessed by the Sleep Scale of the Infant Toddler Social Emotional Assessment (ITSEA; Carter & Briggs-Gowan, 2006)
8.00; 7.00; 9.00; 7.00 .17
PRIMARY
Father Engagement as Assessed by the Activities With Child Scale (Cabrera et al., 2004).
110.51; 143.61; 112.89; 136.58 .88
PRIMARY
Father Involvement as Assessed by the Father Involvement Scale (Coley & Moris, 2002)
20.21; 21.78; 18.15; 21.25 .07
SECONDARY
Infant Eye Gaze Triangular Engagement
2.85; 1.77; 0.14; 0.17 .92
SECONDARY
Infant Eye Gaze Triangular Monitoring
1.94; 2.46; 0.97; 0.85 .81
SECONDARY
Infant Eye Gaze Triangular Tension
1.03; 0.83; 0.25; 0.34 .76
SECONDARY
Infant Eye Gaze Triangular Protest
0.33; 0.34; 0.08; 0.11 .88

Summary

This R01 tests through RCT methodology efficacy of a new intervention designed specifically to aid development of positive coparenting alliances between at-risk (unmarried, uncoupled, low income) African American mothers and fathers having a first baby together.

Eligibility Criteria

Inclusion Criteria

An applicant is considered eligible if the pregnancy is the mother's first with the baby's father; the mother and father are unmarried; and reported income places at or below the county and state poverty line. The target population is African American, but mixed race parents may also enroll so long as at least one parent is African American. Minor parents will be recruited only if legally emancipated or with consent of their parent or guardian (with an exception allowed if minor parent is estranged from parent or LAR). If a potential participant reports a prior history of IPV, s/he may still be eligible for participation pending a more detailed assessment completed by trained project staff using the Danger Assessment Scale (Campbell, 2003).

Exclusion Criteria

Families are excluded if either partner 1) has recently (within the past year) been arrested and convicted for violence (assault) perpetrated against someone other than a current or former partner who is the co-parent of one of their children; 2) demonstrates evidence of psychotic symptoms or suicidal ideation on the Brief Symptom Inventory; or 3) is deemed high risk or in need of more intensive intervention. Risk determination is made by weighing the parent's report on the Danger Assessment Scale (DAS). As a rule of thumb, DAS scores of 9 or higher result in automatic exclusion from the study. However, even with a score below 9, a parent may disclose one or more of the following issues during administration of the DAS - any of which would result in exclusion from the study: 1) parent reports requiring medical care because of significant injuries due to partner's violence, 2) parent says she fears for her life, 3) parent reports that the partner has threatened with a weapon and owns a gun or has a gun in the household; 4) parent reports that the partner has threatened to kill her; 5) parent reports that violence has escalated recently; 6) parent reports the partner's use of illicit drugs such as cocaine, methamphetamines, hallucinogens, or opiates.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03097991). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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