Clinical trial NCT03097991: Randomized Controlled Trial of Prenatal Coparenting Intervention (CoparentRCT)
Official title: Randomized Controlled Trial of Prenatal Coparenting Intervention for African American Fragile Families
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parenting
Keywords: Coparenting Unmarried African-American Prenatal
Lead sponsor: University of South Florida
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2017-03-31
Enrollment: 276
Sex: ALL
Minimum age (years): 14
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed description: Seventy-five randomly-assigned control group families will receive county services as-usual (TAU) for pregnant parents and assistance of the partnering health and human service agencies with referrals to desired services, while 75 experimental group families will receive the same services and aid, plus a 6-session prenatal intervention with a post-natal booster session. The intervention addresses the importance of safe, healthy families for early infant development, the impact a cooperative and sustained coparenting alliance can have in promoting positive infant development, challenges unmarried parents face cultivating a coparenting alliance together when their commitment to one another as romantic or married partners is in doubt, and ways to surmount these obstacles, maintain rapport, and sustain a strong alliance. Participating families, both at intake (prior to the intervention) and then again at 3 and 12 months post-partum, will report beliefs about fatherhood; extent of depressive symptomatology; and quality of the mother-father partnership, including intimate partner violence (IPV). State-of-the-field coparenting observations will be conducted at each follow-up, along with new measures of perceived coparenting communication and respect, father engagement, parent stress, and (at 12 months) infant socioemotional adjustment. Analyses will examine impact of the intervention on promoting more supportive, coordinated post-partum coparenting alliances and more positive adult and infant outcomes. Exploratory analyses will examine questions relevant to father associations with child adjustment and whether the dyadic coparent intervention has an impact on IPV.

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.

Primary outcomes:
measure: System for Coding Interactions in Dyads (SCID) Positive Communication Patterns
timeFrame: Prenatal and 3 months post-partum
measure: System for Coding Interactions in Dyads (SCID) Negative Communication Patterns
timeFrame: Prenatal and 3 months post-partum
measure: System for Coding Interactions in Dyads (SCID) Positive Communication Patterns
timeFrame: Prenatal and 12 months post-partum
measure: System for Coding Interactions in Dyads (SCID) Negative Communication Patterns
timeFrame: Prenatal and 12 months post-partum
measure: Coparenting and Family Rating Scale (CFRS) Coparent Solidarity/Family Harmony
timeFrame: 3 months post-partum
measure: Coparenting and Family Rating Scale (CFRS) Coparent Negativity/Hostility & Competitiveness
timeFrame: 3 months post-partum
measure: Coparenting and Family Rating Scale (CFRS) Coparent Solidarity/Family Harmony
timeFrame: 12 months post-partum
measure: Coparenting and Family Rating Scale (CFRS) Coparent Negativity/Hostility & Competitiveness
timeFrame: 12 months post-partum
measure: Perceived Coparenting Solidarity as Measured by Parenting Alliance Measure (PAM) Communication Subscale
timeFrame: 12 months post-partum compared to 3 months post-partum
measure: Perceived Coparenting Solidarity as Measured by Parenting Alliance Measure (PAM) Respect Subscale
timeFrame: 12 months post-partum compared to 3 months post-partum
measure: Intimate Partner Violence as Assessed by the Psychological Aggression Scale of the Revised-Conflict Tactics Scale (CTS2; Straus et al., 1996).
timeFrame: 12 months post-partum compared to 3 months post-partum
measure: Infant Socio-emotional Competencies as Assessed by the Negative Emotionality Scale of the Infant Toddler Social Emotional Assessment (ITSEA; Carter & Briggs-Gowan, 2006)
timeFrame: 12 months post-partum
measure: Infant Socio-emotional Competencies as Assessed by the Aggression Scale of the Infant Toddler Social Emotional Assessment (ITSEA; Carter & Briggs-Gowan, 2006)
timeFrame: 12 months post-partum
measure: Infant Socio-emotional Competencies as Assessed by the Compliance Scale of the Infant Toddler Social Emotional Assessment (ITSEA; Carter & Briggs-Gowan, 2006)
timeFrame: 12 months post-partum
measure: Infant Socio-emotional Competencies as Assessed by the Sleep Scale of the Infant Toddler Social Emotional Assessment (ITSEA; Carter & Briggs-Gowan, 2006)
timeFrame: 12 months post-partum
measure: Father Engagement as Assessed by the Activities With Child Scale (Cabrera et al., 2004).
timeFrame: 12 months post-partum
measure: Father Involvement as Assessed by the Father Involvement Scale (Coley & Moris, 2002)
timeFrame: 3 months post-partum
Secondary outcomes:
measure: Infant Eye Gaze Triangular Engagement
timeFrame: 12 months compared to 3 months
measure: Infant Eye Gaze Triangular Monitoring
timeFrame: 12 months compared to 3 months
measure: Infant Eye Gaze Triangular Tension
timeFrame: 12 months compared to 3 months
measure: Infant Eye Gaze Triangular Protest
timeFrame: 12 months compared to 3 months
Other outcomes:
measure: Recent Depressive Symptomatology as Gauged by the Edinburgh Depression Scale (EDS; Cox et al., 1987)
timeFrame: 3 months post-partum compared to baseline
measure: Recent Depressive Symptomatology as Gauged by the Edinburgh Depression Scale (EDS; Cox et al., 1987)
timeFrame: 12 months post-partum compared to Baseline
measure: Level of Individual Parenting Stress as Assessed by the Parenting Stress Index Short Form (PSI-SF; Abidin, 1995) Parental Distress Subscale
timeFrame: 12 months post-partum compared to 3 months post-partum
measure: Level of Individual Parenting Stress as Assessed by the Parenting Stress Index Short Form (PSI-SF; Abidin, 1995) Difficult Child Subscale
timeFrame: 12 months post-partum compared to 3 months post-partum
measure: Level of Individual Parenting Stress as Assessed by the Parenting Stress Index Short Form (PSI-SF; Abidin, 1995) Parent-Child Dysfunctional Interaction Subscale
timeFrame: 12 months post-partum compared to 3 months post-partum
Locations:
city: Tampa
country: United States
facility: University of South Florida
state: Florida
Study officials:
affiliation: University of South Florida
name: James P McHale, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: McHale JP, Stover CS, Dube C, Sirotkin YS, Lewis S, McKay K. A culturally grounded prenatal coparenting intervention: Results of a randomized controlled trial with unmarried Black parents. J Fam Psychol. 2022 Jun;36(4):479-489. doi: 10.1037/fam0000965. Epub 2022 Jan 27.