Child MaltreatmentNCT05285267
Engaging Male Caregivers in Effective Prevention Programming to Reduce Risk of Violence and Violence-Related Injury
A study testing Behavioral Parent Support, Shared Parent-Child Activities and COACHES in people with Child Maltreatment and Parenting, run by Florida International University at 1 site in United States.
Trial summary
Fathers are disproportionately involved in and responsible for family violence. Forty percent of maltreatment cases include the child's father, which is quite considerable when one considers mothers spend more time with the child during the day and engage in a greater variety of activities, relative to fathers. Read more about this study
- Who is it for?
- Ages 3 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Child Maltreatment, Parenting
- What is being tested?
- Behavioral Parent Support, Shared Parent-Child Activities and COACHES
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 139 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2022to 31 Jul 2024
- 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 3 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Resident of Western New York
- Have a target child three to six years of age
- Have a male caregiver who consents to participate in the study
- Caregiver and child can speak and understand English.
Who cannot join
- A child with an estimated IQ less than 70
- Any child who is presenting with severe developmental delays (e.g., autism level 2 or 3)
- A child or caregiver who previously participated in the study
- Any target child who has a male or female caregiver who has had a previous, founded, child protection complaint (will be excluded from the study and referred to alternative programming)
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Children and Families
Amherst, New York, 14226
About this study
Fathers are disproportionately involved in and responsible for family violence. Forty percent of maltreatment cases include the child's father, which is quite considerable when one considers mothers spend more time with the child during the day and engage in a greater variety of activities, relative to fathers. Importantly, the majority of child victims were those five and younger.
Contrary to these potential negative impacts, fathers contribute positively to many aspects of child development and overall family functioning, making unique contributions to child peer relationships, language development, academic skills, and the proficiency of the other parent in parenting tasks. Thus, efforts to emphasize the father's role in the child's life, and attenuate any potential risks due to child or family directed violence, represent key public health initiatives within prevention efforts.
There are many potential prevention programs that have been developed to support male caregivers. The Nurturing Fathers program and the Coaching Our Children: Heightening Essential Skills program are two examples of father-focused preventive intervention efforts. However, these approaches have not typically been evaluated as preventive interventions in community-based samples using scientifically rigorous methods. Thus, the present study aims to evaluate the effectiveness of these approaches in reducing family violence and improving male caregiver competencies in a randomized, controlled trial. Specifically, Nurturing Fathers Alone and Nurturing Fathers + COACHES will be compared to an attention control, and male caregivers and their children will be randomly assigned to one of the three groups.
- Conditions
- Child Maltreatment, Parenting
- Being tested
- Behavioral Parent Support, Shared Parent-Child Activities, COACHES
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral Parent SupportBehavioural
Parent training on effective child management strategies
Shared Parent-Child ActivitiesBehavioural
Structured parent-child activities
COACHESBehavioural
This intervention involves practice of parenting strategies with facilitator monitoring and support.
| Study group | Role | What they receive |
|---|---|---|
| Parent-Child Activities | Active comparator | Families assigned to the active control group will participate in weekly "parent-child open house" where the parents will be permitted to meet with other parents in the meeting room and the children will be invited to attend an open gym. There will be no formal curriculum for the parent meetings, but the facilitator will be available to inform the parents of community resources (e.g., mentorship programs) and a resources table will be made available of community activities and referrals in the same manner as the other two groups. Receives: Behavioral: Shared Parent-Child Activities |
| Nurturing Fathers | Experimental | The Nurturing Fathers program (Perlman, 2021) is an adaptation of the Nurturing Parent program. It is a 13-week program that covers the role of fathers, the importance of nurturance rather than fear in fathering, how to effectively play and discipline a child, how to build relationships with the child and co-parent, and it ends with a graduate ceremony. For the present study, consistent with a prevention approach, the investigators will modify the Nurturing Fathers program to focus on the content directly related to parenting skills. The investigators will implement an eight-week program, which is consistent with the duration of prior, successfully attended father-focused interventions (e.g., Fabiano et al., 2009). Receives: Behavioral: Behavioral Parent Support |
| Nurturing Fathers + COACHES | Experimental | The Nurturing Fathers program described above will be implemented as described. For the last 45 minutes of the sessions, fathers will join the child activity group and participate in shared parent-child activities consistent with the COACHES model. For the present study, several adaptations to the clinic-based COACHES program will be made, similar to those successfully deployed in our preliminary study in Head Start preschool settings (Caserta, Fabiano, et al., 2018). The investigators will use the Nurturing Fathers curriculum as the substantive content for each meeting, and then use the parent-child interactions within recreational sports as the forum for practicing skills. Receives: Behavioral: Behavioral Parent Support; Behavioral: COACHES |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behavioral Observations of Parenting
The Dyadic Parent Child Interaction Coding scheme will be used to assess parent behaviors (negative Talk, Indirect and direct commands, labelled and unlabelled praise) and child behaviors (Negative talk, compliance, noncompliance)
Measured: Baseline, End of Intervention (8 weeks later), 1 month after end of intervention (12 weeks later)
Conflict Tactics Scale
This is a measure of conflict resolution and tactics used between the male Completed by the caregiver and the child's other parent. Scores range from "This has never happened to More than 20 times in the past month. The scale measures frequency of behaviors from zero to more than 20 times. Higher scores indicate a worse outcome.
Measured: Baseline, End of Intervention (8 weeks later), 1 month after end of intervention (12 weeks later)
Parenting Alliance Inventory
This is a measure of alignment in parenting practices. Answers range from strongly agree to strongly disagree on a five point scale. Scores range from 1-5, with lower scores indicating improvement.
Measured: Baseline, End of Intervention (8 weeks later), 1 month after end of intervention (12 weeks later)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2022
- Study start1 Mar 2022
- Primary completion30 Jun 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child MaltreatmentStudies 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
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida International University
- Sponsor type
- University, hospital or other
- Collaborators
- Buffalo Prenatal Perinatal Network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05285267
- Sponsor's protocol ID
- IRB-21-0474
- Status last verified
- Sep 2024
- First submitted
- 9 Mar 2022
- Last updated
- 5 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Engaging Male Caregivers in Effective Prevention Programming to Reduce Risk of Violence and Violence-Related Injury
- ClinicalTrials.gov ID
- NCT05285267
- Acronym / sponsor ID
- IRB-21-0474
- Conditions
- Child Maltreatment, Parenting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- Florida International UniversityUniversity, hospital or other
- Collaborators
- Buffalo Prenatal Perinatal Network
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 17 Mar 2022 (actual)
- 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.
Fathers are disproportionately involved in and responsible for family violence. Forty percent of maltreatment cases include the child's father, which is quite considerable when one considers mothers spend more time with the child during the day and engage in a greater variety of activities, relative to fathers. Importantly, the majority of child victims were those five and younger.
Contrary to these potential negative impacts, fathers contribute positively to many aspects of child development and overall family functioning, making unique contributions to child peer relationships, language development, academic skills, and the proficiency of the other parent in parenting tasks. Thus, efforts to emphasize the father's role in the child's life, and attenuate any potential risks due to child or family directed violence, represent key public health initiatives within prevention efforts.
There are many potential prevention programs that have been developed to support male caregivers. The Nurturing Fathers program and the Coaching Our Children: Heightening Essential Skills program are two examples of father-focused preventive intervention efforts. However, these approaches have not typically been evaluated as preventive interventions in community-based samples using scientifically rigorous methods. Thus, the present study aims to evaluate the effectiveness of these approaches in reducing family violence and improving male caregiver competencies in a randomized, controlled trial. Specifically, Nurturing Fathers Alone and Nurturing Fathers + COACHES will be compared to an attention control, and male caregivers and their children will be randomly assigned to one of the three groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Parent-Child Activities | Active comparator | Behavioral: Shared Parent-Child ActivitiesFamilies assigned to the active control group will participate in weekly "parent-child open house" where the parents will be permitted to meet with other parents in the meeting room and the children will be invited to attend an open gym. There will be no formal curriculum for the parent meetings, but the facilitator will be available to inform the parents of community resources (e.g., mentorship programs) and a resources table will be made available of community activities and referrals in the same manner as the other two groups. |
| Nurturing Fathers | Experimental | Behavioral: Behavioral Parent SupportThe Nurturing Fathers program (Perlman, 2021) is an adaptation of the Nurturing Parent program. It is a 13-week program that covers the role of fathers, the importance of nurturance rather than fear in fathering, how to effectively play and discipline a child, how to build relationships with the child and co-parent, and it ends with a graduate ceremony. For the present study, consistent with a prevention approach, the investigators will modify the Nurturing Fathers program to focus on the content directly related to parenting skills. The investigators will implement an eight-week program, which is consistent with the duration of prior, successfully attended father-focused interventions (e.g., Fabiano et al., 2009). |
| Nurturing Fathers + COACHES | Experimental | Behavioral: Behavioral Parent Support, Behavioral: COACHESThe Nurturing Fathers program described above will be implemented as described. For the last 45 minutes of the sessions, fathers will join the child activity group and participate in shared parent-child activities consistent with the COACHES model. For the present study, several adaptations to the clinic-based COACHES program will be made, similar to those successfully deployed in our preliminary study in Head Start preschool settings (Caserta, Fabiano, et al., 2018). The investigators will use the Nurturing Fathers curriculum as the substantive content for each meeting, and then use the parent-child interactions within recreational sports as the forum for practicing skills. |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Resident of Western New York
- Have a target child three to six years of age
- Have a male caregiver who consents to participate in the study
- Caregiver and child can speak and understand English.
Key exclusion criteria (4 listed)
- A child with an estimated IQ less than 70
- Any child who is presenting with severe developmental delays (e.g., autism level 2 or 3)
- A child or caregiver who previously participated in the study
- Any target child who has a male or female caregiver who has had a previous, founded, child protection complaint (will be excluded from the study and referred to alternative programming)
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 |
|---|---|---|
| Behavioral Parent SupportParent training on effective child management strategies | Behavioural | Nurturing Fathers, Nurturing Fathers + COACHES |
| Shared Parent-Child ActivitiesStructured parent-child activities | Behavioural | Parent-Child Activities |
| COACHESThis intervention involves practice of parenting strategies with facilitator monitoring and support. | Behavioural | Nurturing Fathers + COACHES |
Primary outcome
Behavioral Observations of Parenting
Time frame: Baseline, End of Intervention (8 weeks later), 1 month after end of intervention (12 weeks later)
The Dyadic Parent Child Interaction Coding scheme will be used to assess parent behaviors (negative Talk, Indirect and direct commands, labelled and unlabelled praise) and child behaviors (Negative talk, compliance, noncompliance)
Conflict Tactics Scale
Time frame: Baseline, End of Intervention (8 weeks later), 1 month after end of intervention (12 weeks later)
This is a measure of conflict resolution and tactics used between the male Completed by the caregiver and the child's other parent. Scores range from "This has never happened to More than 20 times in the past month. The scale measures frequency of behaviors from zero to more than 20 times. Higher scores indicate a worse outcome.
Parenting Alliance Inventory
Time frame: Baseline, End of Intervention (8 weeks later), 1 month after end of intervention (12 weeks later)
This is a measure of alignment in parenting practices. Answers range from strongly agree to strongly disagree on a five point scale. Scores range from 1-5, with lower scores indicating improvement.
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 5 Sep 2024.
- Individual participant dataSharing planned: Undecided
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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 Behavioral Parent Support, Shared Parent-Child Activities and COACHES in people with Child Maltreatment and Parenting, run by Florida International 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 4 inclusion and 4 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 5 Sep 2024. 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?
Behavioral Observations of Parenting (time frame: Baseline, End of Intervention (8 weeks later), 1 month after end of intervention (12 weeks later)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Sep 2024.