ParentingCoparentRCTNCT03097991
Randomized Controlled Trial of Prenatal Coparenting Intervention (CoparentRCT)
A study testing Focused Coparenting Consultation in people with Parenting, run by University of South Florida at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 14 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Parenting
- What is being tested?
- Focused Coparenting Consultation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 276 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Sep 2015to 18 Dec 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial of Prenatal Coparenting Intervention for African American Fragile Families
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.
Read the 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.
- Conditions
- Parenting
- Being tested
- Focused Coparenting Consultation
- Keywords
- Coparenting Unmarried African-American Prenatal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focused Coparenting ConsultationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Focused Coparenting Consultation |
| Control: Treatment as Usual | No intervention | Receipt of TAU/Resource and Referral supports |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 months post-partum
Secondary outcomes (4)
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.
Measured: 12 months compared to 3 months
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.
Measured: 12 months compared to 3 months
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.
Measured: 12 months compared to 3 months
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.
Measured: 12 months compared to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2017
- Study start26 Sep 2015
- Primary completion18 Dec 2021
- Study completion18 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ParentingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 276 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- James P McHale, PhD, Principal investigator, University of South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03097991
- Sponsor's protocol ID
- NIH 5R01HD082211-01
- Other IDs
- R01HD082211
- Acronym
- CoparentRCT
- Status last verified
- Jan 2022
- First submitted
- 2 Dec 2016
- Last updated
- 15 Dec 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Once all data collection for this project has been completed and study results published, study data stripped of all subject identifiers will be available upon request, provided through electronic means in the original data management files, to qualified researchers.
Publications
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.
PubMed 35084880
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Prenatal Coparenting Intervention for African American Fragile Families
- ClinicalTrials.gov ID
- NCT03097991
- Acronym / sponsor ID
- CoparentRCT / NIH 5R01HD082211-01
- Conditions
- Parenting
- Keywords
- Coparenting Unmarried African-American Prenatal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 276 participants (actual)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 26 Sep 2015 (actual)
- Primary completion
- 18 Dec 2021 (actual)
- Study completion
- 18 Dec 2021 (actual)
- First posted
- 31 Mar 2017 (actual)
- Results
- Posted 15 Dec 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention: Treatment as Usual + Focused Coparenting Consult | Experimental | Behavioral: Focused Coparenting ConsultationReceipt 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 |
| Control: Treatment as Usual | No intervention | –Receipt of TAU/Resource and Referral supports |
Who may qualify
- Ages
- 14 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Focused Coparenting ConsultationSix 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. | Behavioural | Intervention: Treatment as Usual + Focused Coparenting Consult |
Primary outcome
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.
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.
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.
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.
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).
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).
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).
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).
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.
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.
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.
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.
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.
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.
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.
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.
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.
4 secondary outcomes
Infant Eye Gaze Triangular Engagement
Time frame: 12 months compared to 3 months
Infant Eye Gaze Triangular Monitoring
Time frame: 12 months compared to 3 months
Infant Eye Gaze Triangular Tension
Time frame: 12 months compared to 3 months
Infant Eye Gaze Triangular Protest
Time frame: 12 months compared to 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 35084880McHale 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.
- Individual participant dataSharing planned: Yes. Once all data collection for this project has been completed and study results published, study data stripped of all subject identifiers will be available upon request, provided through electronic means in the original data management files, to qualified researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James P McHale, PhD principal investigator
University of South Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Focused Coparenting Consultation in people with Parenting, run by University of South Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Dec 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
System for Coding Interactions in Dyads (SCID) Positive Communication Patterns (time frame: Prenatal and 3 months post-partum). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03097991, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2022.