Randomized Controlled Trial of Prenatal Coparenting Intervention (CoparentRCT)

Parenting Clinical Trial

— CoparentRCT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03097991
• Other study ID #: NIH 5R01HD082211-01
• Secondary ID: R01HD082211
• Status: Completed
• Phase: N/A
• Start date: September 26, 2015
• Est. completion date: December 18, 2021

Study information

• Verified date: January 2022
• Source: University of South Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 276
• Est. completion date: December 18, 2021
• Est. primary completion date: December 18, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Parenting

Intervention

Behavioral:
• Focused Coparenting Consultation
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.

Locations

Country	Name	City	State
United States	University of South Florida	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of South Florida	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. Ep — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Recent Depressive Symptomatology as Gauged by the Edinburgh Depression Scale (EDS; Cox et al., 1987)	Scores on EDS range from 0 to 30 with higher scores indicating more depressive symptoms in the past week.	3 months post-partum compared to baseline
Other	Recent Depressive Symptomatology as Gauged by the Edinburgh Depression Scale (EDS; Cox et al., 1987)	Scores on EDS range from 0 to 30 with higher scores indicating more depressive symptoms in the past week.	12 months post-partum compared to Baseline
Other	Level of Individual Parenting Stress as Assessed by the Parenting Stress Index Short Form (PSI-SF; Abidin, 1995) Parental Distress Subscale	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.	12 months post-partum compared to 3 months post-partum
Other	Level of Individual Parenting Stress as Assessed by the Parenting Stress Index Short Form (PSI-SF; Abidin, 1995) Difficult Child Subscale	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.	12 months post-partum compared to 3 months post-partum
Other	Level of Individual Parenting Stress as Assessed by the Parenting Stress Index Short Form (PSI-SF; Abidin, 1995) Parent-Child Dysfunctional Interaction Subscale	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.	12 months post-partum compared to 3 months post-partum
Primary	System for Coding Interactions in Dyads (SCID) Positive Communication Patterns	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.	Prenatal and 3 months post-partum
Primary	System for Coding Interactions in Dyads (SCID) Negative Communication Patterns	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.	Prenatal and 3 months post-partum
Primary	System for Coding Interactions in Dyads (SCID) Positive Communication Patterns	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.	Prenatal and 12 months post-partum
Primary	System for Coding Interactions in Dyads (SCID) Negative Communication Patterns	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.	Prenatal and 12 months post-partum
Primary	Coparenting and Family Rating Scale (CFRS) Coparent Solidarity/Family Harmony	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).	3 months post-partum
Primary	Coparenting and Family Rating Scale (CFRS) Coparent Negativity/Hostility & Competitiveness	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).	3 months post-partum
Primary	Coparenting and Family Rating Scale (CFRS) Coparent Solidarity/Family Harmony	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).	12 months post-partum
Primary	Coparenting and Family Rating Scale (CFRS) Coparent Negativity/Hostility & Competitiveness	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).	12 months post-partum
Primary	Perceived Coparenting Solidarity as Measured by Parenting Alliance Measure (PAM) Communication Subscale	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.	12 months post-partum compared to 3 months post-partum
Primary	Perceived Coparenting Solidarity as Measured by Parenting Alliance Measure (PAM) Respect Subscale	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.	12 months post-partum compared to 3 months post-partum
Primary	Intimate Partner Violence as Assessed by the Psychological Aggression Scale of the Revised-Conflict Tactics Scale (CTS2; Straus et al., 1996).	Scores on the Psychological Aggression Scale range from 0 to 175 and higher scores indicate more frequent acts of psychological aggression by partner.	12 months post-partum compared to 3 months post-partum
Primary	Infant Socio-emotional Competencies as Assessed by the Negative Emotionality Scale of the Infant Toddler Social Emotional Assessment (ITSEA; Carter & Briggs-Gowan, 2006)	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.	12 months post-partum
Primary	Infant Socio-emotional Competencies as Assessed by the Aggression Scale of the Infant Toddler Social Emotional Assessment (ITSEA; Carter & Briggs-Gowan, 2006)	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.	12 months post-partum
Primary	Infant Socio-emotional Competencies as Assessed by the Compliance Scale of the Infant Toddler Social Emotional Assessment (ITSEA; Carter & Briggs-Gowan, 2006)	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.	12 months post-partum
Primary	Infant Socio-emotional Competencies as Assessed by the Sleep Scale of the Infant Toddler Social Emotional Assessment (ITSEA; Carter & Briggs-Gowan, 2006)	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.	12 months post-partum
Primary	Father Engagement as Assessed by the Activities With Child Scale (Cabrera et al., 2004).	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.	12 months post-partum
Primary	Father Involvement as Assessed by the Father Involvement Scale (Coley & Moris, 2002)	A composite score based on sum of items ranges between 6 to 24 with higher scores signifying greater paternal involvement.	3 months post-partum
Secondary	Infant Eye Gaze Triangular Engagement	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.	12 months compared to 3 months
Secondary	Infant Eye Gaze Triangular Monitoring	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.	12 months compared to 3 months
Secondary	Infant Eye Gaze Triangular Tension	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.	12 months compared to 3 months
Secondary	Infant Eye Gaze Triangular Protest	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.	12 months compared to 3 months