Parent-Child RelationsFF1NCT01901536
Family Foundations Coparenting Pilot Trial
A study testing Family Foundations Coparenting Program in people with Parent-Child Relations, run by Penn State University at 1 site in United States.
Trial summary
This is a research study to evaluate the effectiveness of the Family Foundations program and to better understand how families cope with having a new baby. The research questions include: What is the effectiveness of the Family Foundations program? How do families cope with having a new baby? Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parent-Child Relations
- What is being tested?
- Family Foundations Coparenting Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 497 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2002to Nov 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Expecting first child
- Couple living together and planning to raise child together
- 18 years or older
Who cannot join
- Not first child
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State University, Prevention Research Center
University Park, Pennsylvania, 16802
About this study
Official title: Promotion of Coparenting During Family Formation Period
This is a research study to evaluate the effectiveness of the Family Foundations program and to better understand how families cope with having a new baby. The research questions include: What is the effectiveness of the Family Foundations program? How do families cope with having a new baby?
- Conditions
- Parent-Child Relations
- Being tested
- Family Foundations Coparenting Program
- Keywords
- First time parents, Coparenting, Family Foundations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family Foundations Coparenting ProgramBehavioural
Family Foundations, a program for adult couples expecting their first child, is designed to help them establish positive parenting skills and adjust to the physical, social, and emotional challenges of parenthood. Program topics include coping with postpartum depression and stress, creating a caring environment, and developing the child's social and emotional competence.
Family Foundations is delivered to groups of couples through four prenatal and four postnatal classes of 2 hours each. Prenatal classes are started during the fifth or sixth month of pregnancy, and the postnatal classes end when the children are 6 months old.
Family Foundations is delivered in a community setting by childbirth educators who have received 3 days of training from Family Foundations staff.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Couples randomly assigned to the Intervention Group received the Family Foundations Coparenting Program. Receives: Behavioral: Family Foundations Coparenting Program |
| Control Group | No intervention | Couples in the Control group did not receive the Family Foundations Coparenting Program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coparenting Quality
We assessed coparenting relationship quality with the 31-item Coparenting Scale, which was created based on prior work (e.g., Abidin \& Brunner, 1995; Cordova, 2001; Frank, Olmstead, Wagner,\& Laub, 1991; Margolin et al., 2001; McHale, 1997). The overall score represents an average of items covering theoretically important domains: coparental agreement, support,undermining, and exposure of the child to conflict.
Measured: up to 3.5 years after baseline
Secondary outcomes (2)
Parenting Discipline Practices
The Parenting Scale assesses discipline practices in parents of children from 18-48 months (Arnold,O'Leary, Wolff, \& Acker, 1993).
Measured: 3.5 years after baseline
Child Behavior Problems
Child behavior problems were measured using the Child Behavior Checklist (CBCL; Achenbach \& Rescorla, 2000), reported by mothers only. From this 100-item questionnaire, separate sub-scales were calculated using scoring conventions. From these, we examined three overall scores which were normed for child age:
Total problems, Externalizing problems, and Internalizing problems. In addition, we examined two specific sub-scales given their relevance to this study: Aggression and Attention/Hyperactivity.
Measured: 3.5 years after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2013 (estimated)
- Study startDec 2002
- Primary completionNov 2007
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Parent-Child RelationsStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 497 participants (actual)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark Feinberg, Feinberg, Mark, Ph.D.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01901536
- Sponsor's protocol ID
- MH64125-01A2
- Acronym
- FF1
- Status last verified
- Feb 2021
- First submitted
- 12 Jul 2013
- Last updated
- 8 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Feinberg ME, Jones DE, Kan ML, Goslin MC. Effects of family foundations on parents and children: 3.5 years after baseline. J Fam Psychol. 2010 Oct;24(5):532-42. doi: 10.1037/a0020837.
PubMed 20954763Feinberg ME, Kan ML, Goslin MC. Enhancing coparenting, parenting, and child self-regulation: effects of family foundations 1 year after birth. Prev Sci. 2009 Sep;10(3):276-85. doi: 10.1007/s11121-009-0130-4.
PubMed 19381809Feinberg ME, Kan ML. Establishing family foundations: intervention effects on coparenting, parent/infant well-being, and parent-child relations. J Fam Psychol. 2008 Apr;22(2):253-63. doi: 10.1037/0893-3200.22.2.253.
PubMed 18410212Moran LJ, Lee JK, Jones D, Fronberg K, Feinberg ME. Coparenting-focused preventive intervention reduces postnatal maternal BMI and buffers impact of cortisol. Obesity (Silver Spring). 2022 Aug;30(8):1564-1572. doi: 10.1002/oby.23466. Epub 2022 Jul 19.
PubMed 35854331Roettger ME, Schreier HMC, Feinberg ME, Jones DE. Prospective Relations Between Prenatal Maternal Cortisol and Child Health Outcomes. Psychosom Med. 2019 Jul/Aug;81(6):557-565. doi: 10.1097/PSY.0000000000000705.
PubMed 31058707
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promotion of Coparenting During Family Formation Period
- ClinicalTrials.gov ID
- NCT01901536
- Acronym / sponsor ID
- FF1 / MH64125-01A2
- Conditions
- Parent-Child Relations
- Keywords
- First time parents, Coparenting, Family Foundations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 497 participants (actual)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Study start
- Dec 2002
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 17 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a research study to evaluate the effectiveness of the Family Foundations program and to better understand how families cope with having a new baby. The research questions include: What is the effectiveness of the Family Foundations program? How do families cope with having a new baby?
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Family Foundations Coparenting ProgramCouples randomly assigned to the Intervention Group received the Family Foundations Coparenting Program. |
| Control Group | No intervention | –Couples in the Control group did not receive the Family Foundations Coparenting Program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Expecting first child
- Couple living together and planning to raise child together
- 18 years or older
Key exclusion criteria (1 listed)
- Not first child
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 |
|---|---|---|
| Family Foundations Coparenting ProgramFamily Foundations, a program for adult couples expecting their first child, is designed to help them establish positive parenting skills and adjust to the physical, social, and emotional challenges of parenthood. Program topics include coping with postpartum depression and stress, creating a caring environment, and developing the child's social and emotional competence. Family Foundations is delivered to groups of couples through four prenatal and four postnatal classes of 2 hours each. Prenatal classes are started during the fifth or sixth month of pregnancy, and the postnatal classes end when the children are 6 months old. Family Foundations is delivered in a community setting by childbirth educators who have received 3 days of training from Family Foundations staff. | Behavioural | Intervention Group |
Primary outcome
Coparenting Quality
Time frame: up to 3.5 years after baseline
We assessed coparenting relationship quality with the 31-item Coparenting Scale, which was created based on prior work (e.g., Abidin \& Brunner, 1995; Cordova, 2001; Frank, Olmstead, Wagner,\& Laub, 1991; Margolin et al., 2001; McHale, 1997). The overall score represents an average of items covering theoretically important domains: coparental agreement, support,undermining, and exposure of the child to conflict.
2 secondary outcomes
Parenting Discipline Practices
Time frame: 3.5 years after baseline
Child Behavior Problems
Time frame: 3.5 years after baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2021.
- Results publication: PubMed 20954763Feinberg ME, Jones DE, Kan ML, Goslin MC. Effects of family foundations on parents and children: 3.5 years after baseline. J Fam Psychol. 2010 Oct;24(5):532-42. doi: 10.1037/a0020837.
- Results publication: PubMed 19381809Feinberg ME, Kan ML, Goslin MC. Enhancing coparenting, parenting, and child self-regulation: effects of family foundations 1 year after birth. Prev Sci. 2009 Sep;10(3):276-85. doi: 10.1007/s11121-009-0130-4.
- Results publication: PubMed 18410212Feinberg ME, Kan ML. Establishing family foundations: intervention effects on coparenting, parent/infant well-being, and parent-child relations. J Fam Psychol. 2008 Apr;22(2):253-63. doi: 10.1037/0893-3200.22.2.253.
- Derived from this study: PubMed 35854331Moran LJ, Lee JK, Jones D, Fronberg K, Feinberg ME. Coparenting-focused preventive intervention reduces postnatal maternal BMI and buffers impact of cortisol. Obesity (Silver Spring). 2022 Aug;30(8):1564-1572. doi: 10.1002/oby.23466. Epub 2022 Jul 19.
- Derived from this study: PubMed 31058707Roettger ME, Schreier HMC, Feinberg ME, Jones DE. Prospective Relations Between Prenatal Maternal Cortisol and Child Health Outcomes. Psychosom Med. 2019 Jul/Aug;81(6):557-565. doi: 10.1097/PSY.0000000000000705.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family Foundations Coparenting Program in people with Parent-Child Relations, run by Penn State University 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 3 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 8 Feb 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Coparenting Quality (time frame: up to 3.5 years after baseline). 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 NCT01901536, which also lists 5 linked publications.
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 8 Feb 2021.