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Completed

NCT Number: NCT03097991

Randomized Controlled Trial of Prenatal Coparenting Intervention (CoparentRCT)

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.

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Key information

Conditions

Parenting

Age range

14 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of South Florida

Tampa, Florida, 33612, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Focused Coparenting Consultation

Behavioral

Six 90-minute sessions completed within 10 weeks address importance of coparenting for child development; overcoming challenges to coparenting collaboratively; anger and conflict management and communication skills. Parents develop a coparenting plan to support one another's involvement as parents to the baby. A 90-minute booster session one month after the baby's birth reinforces lessons learned in the 6-session intervention.

Primary outcomes

  1. System for Coding Interactions in Dyads (SCID) Positive Communication Patterns

    Time frame: Prenatal and 3 months post-partum

    Composite of SCID observational measures of positive mother-father interaction (Problem Solving Communication**, Support**, Cohesiveness*, Withdrawal**, Positive Affect**) * Couple variable, there is only one score for the couple.

    ** Individual variable, there are two separate scores for mothers and fathers separately.

    Each sub-scale scores range from 1 to 5. Total scale scores were combined by averaging the individual and couple scales, with higher scores indicating more positive patterns in couple interaction (total scale score range 1-5).

    Change from Prenatal to 3 months post-partum is evaluated.

  2. System for Coding Interactions in Dyads (SCID) Negative Communication Patterns

    Time frame: Prenatal and 3 months post-partum

    Composite of SCID observational measures of negative mother-father interaction (Negative Escalation*, Verbal Aggression**, Attempts to Control**, Negativity/conflict**, Coerciveness**, Dysphoric Affect**) * Couple variable, there is only one score for the couple.

    ** Individual variable, there are two separate scores for mothers and fathers separately.

    Each sub-scale scores range from 1 to 5. Total scale scores were combined by summing up the individual scales, with higher scores indicating more negative patterns in couple interaction.

    Each sub-scale scores range from 1 to 5. Total scale scores were combined by averaging the individual and couple scales, with higher scores indicating more positive patterns in couple interaction (total scale score range 1-5).

    Change from prenatal to 3 months post-partum is evaluated.

  3. System for Coding Interactions in Dyads (SCID) Positive Communication Patterns

    Time frame: Prenatal and 12 months post-partum

    Composite of SCID observational measures of positive mother-father interaction (Problem Solving Communication**, Support**, Cohesiveness*, Withdrawal**, Positive Affect**) * Couple variable, there is only one score for the couple.

    ** Individual variable, there are two separate scores for mothers and fathers separately.

    Each sub-scale scores range from 1 to 5. Total scale scores were combined by averaging the individual and couple scales, with higher scores indicating more positive patterns in couple interaction (total scale score range 1-5).

    Change from prenatal to 12 months post-partum is evaluated.

  4. System for Coding Interactions in Dyads (SCID) Negative Communication Patterns

    Time frame: Prenatal and 12 months post-partum

    Composite of SCID observational measures of negative mother-father interaction (Negative Escalation*, Verbal Aggression**, Attempts to Control**, Negativity/conflict**, Coerciveness**, Dysphoric Affect**) * Couple variable, there is only one score for the couple.

    ** Individual variable, there are two separate scores for mothers and fathers separately.

    Each sub-scale scores range from 1 to 5. Total scale scores were combined by averaging the individual and couple scales, with higher scores indicating more positive patterns in couple interaction (total scale score range 1-5).

    Change from prenatal to 12 months post-partum is evaluated.

  5. Coparenting and Family Rating Scale (CFRS) Coparent Solidarity/Family Harmony

    Time frame: 3 months post-partum

    Composite of CFRS observational measures of warmth (range 1-7), cooperation (range 1-7), and sensitivity (range 1-7) and negatively loaded disengagement (range 1-7). Total scale scores were combined by averaging up the sub-scale scores, with higher values indicating better coparent solidarity/family harmony (total scale score range 1-7).

  6. Coparenting and Family Rating Scale (CFRS) Coparent Negativity/Hostility & Competitiveness

    Time frame: 3 months post-partum

    Composite CFRS observational measures of competition (range 1-7), over stimulation (range 1-7), and verbal sparring (range 1-5).

    Total scale scores were combined by averaging up the sub-scale scores, with higher values indicating better coparent solidarity/family harmony (total scale score range 1-7).

  7. Coparenting and Family Rating Scale (CFRS) Coparent Solidarity/Family Harmony

    Time frame: 12 months post-partum

    Composite of CFRS observational measures of warmth (range 1-7), cooperation (range 1-7), and sensitivity (range 1-7) and negatively loaded disengagement (range 1-7). Total scale scores were combined by averaging up the sub-scale scores, with higher values indicating better coparent solidarity/family harmony (total scale score range 1-7).

  8. Coparenting and Family Rating Scale (CFRS) Coparent Negativity/Hostility & Competitiveness

    Time frame: 12 months post-partum

    Composite CFRS observational measures of competition (range 1-7), over stimulation (range 1-7), and verbal sparring (range 1-5).

    Total scale scores were combined by averaging up the sub-scale scores, with higher values indicating better coparent solidarity/family harmony (total scale score range 1-7).

  9. Perceived Coparenting Solidarity as Measured by Parenting Alliance Measure (PAM) Communication Subscale

    Time frame: 12 months post-partum compared to 3 months post-partum

    Scores on Parenting Alliance Measure range from 20 to 100 with higher scores indicating more positive perceived alliance between parents. Scores on the Communication subscale range from 17 to 85.

  10. Perceived Coparenting Solidarity as Measured by Parenting Alliance Measure (PAM) Respect Subscale

    Time frame: 12 months post-partum compared to 3 months post-partum

    Scores on Parenting Alliance Measure range from 20 to 100 with higher scores indicating more positive perceived alliance between parents. Scores on the Respect subscale range from 3 to 15.

  11. Intimate Partner Violence as Assessed by the Psychological Aggression Scale of the Revised-Conflict Tactics Scale (CTS2; Straus et al., 1996).

    Time frame: 12 months post-partum compared to 3 months post-partum

    Scores on the Psychological Aggression Scale range from 0 to 175 and higher scores indicate more frequent acts of psychological aggression by partner.

  12. Infant Socio-emotional Competencies as Assessed by the Negative Emotionality Scale of the Infant Toddler Social Emotional Assessment (ITSEA; Carter & Briggs-Gowan, 2006)

    Time frame: 12 months post-partum

    Items are rated on the following 3-point scale: (0) Not true/rarely, (1) Somewhat true/sometimes, and (2) Very true/often. A "No opportunity" code allows parents to indicate that they have not had the opportunity to observe certain behaviors (e.g., behavior with peers).

    Scores on Negative Emotionality scale which includes 13 items range from 0 to 26 with higher scores are considered indicative of a deficit or delay.

  13. Infant Socio-emotional Competencies as Assessed by the Aggression Scale of the Infant Toddler Social Emotional Assessment (ITSEA; Carter & Briggs-Gowan, 2006)

    Time frame: 12 months post-partum

    Items are rated on the following 3-point scale: (0) Not true/rarely, (1) Somewhat true/sometimes, and (2) Very true/often. A "No opportunity" code allows parents to indicate that they have not had the opportunity to observe certain behaviors (e.g., behavior with peers).

    Scores on the Aggression Scale which includes 12 items range from 0 to 24 and higher scores are considered indicative of a deficit or delay.

  14. Infant Socio-emotional Competencies as Assessed by the Compliance Scale of the Infant Toddler Social Emotional Assessment (ITSEA; Carter & Briggs-Gowan, 2006)

    Time frame: 12 months post-partum

    Items are rated on the following 3-point scale: (0) Not true/rarely, (1) Somewhat true/sometimes, and (2) Very true/often. A "No opportunity" code allows parents to indicate that they have not had the opportunity to observe certain behaviors (e.g., behavior with peers).

    Scores on Compliance Scale which includes 8 items range from 0 to16 with lower scores considered indicative of a deficit or delay.

  15. Infant Socio-emotional Competencies as Assessed by the Sleep Scale of the Infant Toddler Social Emotional Assessment (ITSEA; Carter & Briggs-Gowan, 2006)

    Time frame: 12 months post-partum

    Items are rated on the following 3-point scale: (0) Not true/rarely, (1) Somewhat true/sometimes, and (2) Very true/often. A "No opportunity" code allows parents to indicate that they have not had the opportunity to observe certain behaviors (e.g., behavior with peers).

    Scores on the Sleep Scale which includes 5 items range from 0 to 10 with higher scores considered indicative of a deficit or delay.

  16. Father Engagement as Assessed by the Activities With Child Scale (Cabrera et al., 2004).

    Time frame: 12 months post-partum

    This self report consists of 34 items on which the parent reports the frequency with which the father was engaged in various activities with the child in the past month. Questions were answered on a Likert-type scale from 1 (more than once a day) to 6 (not at all); all items were reverse scored such that higher scores reflect more frequent activity.

    Father engagement is assessed across six sub-scales (Socialization - 11 items, Management- 3 items, Didactic - 7 items, Physical play/warmth - 6 items, Caregiving - 7 items) with composite scores computed by averaging responses across items.

    Scores range from 34 to 204 for the total scale. Higher scores reflect more frequent activity with the child.

  17. Father Involvement as Assessed by the Father Involvement Scale (Coley & Moris, 2002)

    Time frame: 3 months post-partum

    A composite score based on sum of items ranges between 6 to 24 with higher scores signifying greater paternal involvement.

Secondary outcomes

  1. Infant Eye Gaze Triangular Engagement

    Time frame: 12 months compared to 3 months

    To assess infant triangular capacities, multi-shift gaze patterns in which infant looks from one parent to another, and then rapidly redirects gaze back to the first parent after having shifted once were counted. Four categories of triangular bids were defined, which corresponded to the different affective configurations: triangular engagement (TE), triangular monitoring (TM), triangular tension (TT), and triangular protest (TP). When the affective configurations addressed to the parents were not in the same category, the one addressed to P2 was selected as determinant of the triangular bid category.

  2. Infant Eye Gaze Triangular Monitoring

    Time frame: 12 months compared to 3 months

    To assess infant triangular capacities, multi-shift gaze patterns in which infant looks from one parent to another, and then rapidly redirects gaze back to the first parent after having shifted once were counted. Four categories of triangular bids were defined, which corresponded to the different affective configurations: triangular engagement (TE), triangular monitoring (TM), triangular tension (TT), and triangular protest (TP). When the affective configurations addressed to the parents were not in the same category, the one addressed to P2 was selected as determinant of the triangular bid category.

  3. Infant Eye Gaze Triangular Tension

    Time frame: 12 months compared to 3 months

    To assess infant triangular capacities, multi-shift gaze patterns in which infant looks from one parent to another, and then rapidly redirects gaze back to the first parent after having shifted once were counted. Four categories of triangular bids were defined, which corresponded to the different affective configurations: triangular engagement (TE), triangular monitoring (TM), triangular tension (TT), and triangular protest (TP). When the affective configurations addressed to the parents were not in the same category, the one addressed to P2 was selected as determinant of the triangular bid category.

  4. Infant Eye Gaze Triangular Protest

    Time frame: 12 months compared to 3 months

    To assess infant triangular capacities, multi-shift gaze patterns in which infant looks from one parent to another, and then rapidly redirects gaze back to the first parent after having shifted once were counted. Four categories of triangular bids were defined, which corresponded to the different affective configurations: triangular engagement (TE), triangular monitoring (TM), triangular tension (TT), and triangular protest (TP). When the affective configurations addressed to the parents were not in the same category, the one addressed to P2 was selected as determinant of the triangular bid category.

Other outcomes

  1. Recent Depressive Symptomatology as Gauged by the Edinburgh Depression Scale (EDS; Cox et al., 1987)

    Time frame: 3 months post-partum compared to baseline

    Scores on EDS range from 0 to 30 with higher scores indicating more depressive symptoms in the past week.

  2. Recent Depressive Symptomatology as Gauged by the Edinburgh Depression Scale (EDS; Cox et al., 1987)

    Time frame: 12 months post-partum compared to Baseline

    Scores on EDS range from 0 to 30 with higher scores indicating more depressive symptoms in the past week.

  3. Level of Individual Parenting Stress as Assessed by the Parenting Stress Index Short Form (PSI-SF; Abidin, 1995) Parental Distress Subscale

    Time frame: 12 months post-partum compared to 3 months post-partum

    Scores range from 12 to 60 on each of the three sub-scales, and total score ranges from 36 to 180; high scores on the sub-scales and PSI-SF total score indicating greater levels of stress.

  4. Level of Individual Parenting Stress as Assessed by the Parenting Stress Index Short Form (PSI-SF; Abidin, 1995) Difficult Child Subscale

    Time frame: 12 months post-partum compared to 3 months post-partum

    Scores range from 12 to 60 on each of the three sub-scales, and total score ranges from 36 to 180; high scores on the sub-scales and PSI-SF total score indicating greater levels of stress.

  5. Level of Individual Parenting Stress as Assessed by the Parenting Stress Index Short Form (PSI-SF; Abidin, 1995) Parent-Child Dysfunctional Interaction Subscale

    Time frame: 12 months post-partum compared to 3 months post-partum

    Scores range from 12 to 60 on each of the three sub-scales, and total score ranges from 36 to 180; high scores on the sub-scales and PSI-SF total score indicating greater levels of stress.

Sponsors and collaborators

Lead sponsor

University of South Florida

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Official study title

Randomized Controlled Trial of Prenatal Coparenting Intervention for African American Fragile Families

Acronym: CoparentRCT

Important dates

Study start
2015
Primary completion
2021
Study completion
2021
First posted
Mar 31, 2017
Registry last updated
Dec 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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