Randomized Controlled Trial of Prenatal Coparenting Intervention (CoparentRCT)

NCT03097991 | Completed Results DMC

• 2 other identifiers: NIH 5R01HD082211-01R01HD082211
• Study Type: interventional
• Target: 276
• Locations: 1 country
• Sites: 1

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.

Conditions

Parenting

Keywords

Coparenting Unmarried African-American Prenatal

Outcome Measures

Primary Outcomes (17)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (4)

• Infant Eye Gaze Triangular Engagement

  12 months compared to 3 months

• Infant Eye Gaze Triangular Monitoring

  12 months compared to 3 months

• Infant Eye Gaze Triangular Tension

  12 months compared to 3 months

• Infant Eye Gaze Triangular Protest

  12 months compared to 3 months

Other Outcomes (5)

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

  3 months post-partum compared to baseline

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

  12 months post-partum compared to Baseline

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

  12 months post-partum compared to 3 months post-partum

Study Arms (2)

Intervention: Treatment as Usual + Focused Coparenting Consult

EXPERIMENTAL

Receipt of Treatment As Usual/Resource and Referral supports, plus opportunity to complete six 90-minute Focused Coparenting Consultation (FCC) sessions followed by one postnatal booster session designed to strengthen the mother-father coparenting alliance

Behavioral: Focused Coparenting Consultation

Control: Treatment as Usual

NO INTERVENTION

Receipt of TAU/Resource and Referral supports

Interventions

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.

Intervention: Treatment as Usual + Focused Coparenting Consult

Eligibility Criteria

• Age: 14 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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).

Sponsors & Collaborators

• University of South Florida: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

University of South Florida

Tampa, Florida, 33612, United States

Location

Related 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. Epub 2022 Jan 27.

  PMID: 35084880 RESULT

Results Point of Contact

• Title: Dr. James McHale
• Organization: University of South Florida

jmchale@usf.edu

7278734848

Study Officials

• James P McHale, PhD

  University of South Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2016
• First Posted: March 31, 2017
• Study Start: September 26, 2015
• Primary Completion: December 18, 2021
• Study Completion: December 18, 2021
• Last Updated: December 15, 2022
• Results First Posted: December 15, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Starting 6 months after publication for 5 years.
• Access Criteria: Any request for study data which meets reasonable standards of scientific integrity will be considered by the study investigators, with the expectation that any costs incurred in providing such data accrued from this project will be covered by the requesting investigator.

Locations

US (1)