Father - Child Relations Clinical Trial
— DAADOfficial title:
African American Non-Resident Fatherhood Program: Effects on Child/Family Outcomes
| Verified date | April 2023 |
| Source | Rush University Medical Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The number of children living apart from their fathers has grown nationally, and the greatest percentage is evident among African American (AA) families; two-thirds of all African American children live in households without their biological father. Research supports the importance of positive fathering in the lives of children. But in order for children to benefit from their fathers' involvement, the father-child relationship must be timely and sustained. This study will test culturally relevant interventions aimed at increasing non-resident (not living with the child) AA fathers' involvement with their children.
| Status | Completed |
| Enrollment | 308 |
| Est. completion date | September 24, 2018 |
| Est. primary completion date | September 24, 2018 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Male |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - AA biological father of a child 2 to 5 years old - Child lives with father no more than 48 hours per week (e.g., spends the weekends with his or her father) - The child lives with the biological mother (or other custodial relative such as grandmother) in the metropolitan Chicago area. - These fathers are referred to as AA non-resident fathers. Additional criteria include: (1) child's mother is willing to consent to complete the child assessments; - Child's mother is amenable to facilitating opportunities for fathers to interact with their children in order to practice skills learned in the program - Father is able and willing to travel to one of two intervention sites to attend a weekly program. - The study is limited to fathers with a target child aged 2-5 years. - The rationale for this limit is based on the developmental phase when families are most vulnerable to decreased father involvement and children are highly dependent on parenting for their growth and development. Exclusion Criteria: - Fathers with histories of child abuse, neglect, or violence perpetuated against the child or the child's mother (based on mother or father report). |
| Country | Name | City | State |
|---|---|---|---|
| United States | Rush University Medical Center | Chicago | Illinois |
| Lead Sponsor | Collaborator |
|---|---|
| Rush University Medical Center | National Institute of Nursing Research (NINR) |
United States,
Julion W, Gross D, Barclay-McLaughlin G, Fogg L. "It's not just about MOMMAS": African-American non-resident fathers' views of paternal involvement. Res Nurs Health. 2007 Dec;30(6):595-610. doi: 10.1002/nur.20223. — View Citation
Julion W, Sumo J, Schoeny ME, Breitenstein SM, Bounds DT. Recruitment, Retention, and Intervention Outcomes from the Dedicated African American Dad (DAAD) Study. J Urban Health. 2021 Oct;98(Suppl 2):133-148. doi: 10.1007/s11524-021-00549-8. Epub 2021 Jul — View Citation
Julion WA, Breitenstein SM, Waddell D. Fatherhood intervention development in collaboration with African American non-resident fathers. Res Nurs Health. 2012 Oct;35(5):490-506. doi: 10.1002/nur.21492. Epub 2012 Jun 8. — View Citation
Julion WA, Sumo J, Bounds DT, Breitenstein SM, Schoeny M, Gross D, Fogg L. Study protocol for a randomized clinical trial of a fatherhood intervention for African American non-resident fathers: Can we improve father and child outcomes? Contemp Clin Trials — View Citation
Julion WA, Sumo J, Bounds DT. A tripartite model for recruiting African-Americans into fatherhood intervention research. Public Health Nurs. 2018 Sep;35(5):420-426. doi: 10.1111/phn.12411. Epub 2018 May 9. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Building Bridges To Fatherhood (BBTF) Social Context Validity | An investigator developed Weekly Satisfaction and Program Satisfaction Survey was used to measure the levels of consumer satisfaction and active participation in the intervention. The 5-item weekly satisfaction survey minimum score is 0 and highest score is 15. The 16-item Program Satisfaction survey minimum score is 0 and the highest score is 48. Higher scores reflect greater satisfaction. | 9 weeks post baseline | |
| Primary | Father Involvement as Measured by the Fragile Families Survey - Father Report | The Fragile Families Survey (FFS) Measures the frequency with which fathers provide material and in-kind support and directly interact with their child The minimum score is 13, and the maximum score is 52. Higher scores mean a better outcome. | Mean/Standard Error (SE) at Baseline, 12, and 24 weeks | |
| Primary | Father Involvement as Measured by the Julion Index of Paternal Involvement - Father Report | The Julion Index of Paternal Involvement (JIPI) measured the frequency with which fathers provide material and in-kind support and engage in direct father-child interaction.
The minimum value is 19 and the maximum value is 76. Higher scores mean a better outcome. |
Change from baseline to 12 and 24 weeks | |
| Secondary | Taylor Inventory of Self-Esteem (Positive) | The 16-item Taylor Inventory of Self-esteem is a measure of self-esteem and rewards and costs to self. The minimum value on the 8-item positive subscale is zero, and the maximum value is 64. Higher scores are better outcomes. | Mean/SE at Baseline, 12, and 24 weeks | |
| Secondary | Taylor Inventory of Self-Esteem (Negative) | The 16-item Taylor Inventory of Self-esteem is a measure of self-esteem and rewards and costs to self. The minimum value on the 8-item negative subscale is zero, and the maximum value is 64. Higher scores are worse outcomes. | Baseline, 12, and 24 weeks | |
| Secondary | Perceived Stress Scale (Negative) | The Perceived Stress Scale examines the degree to which situations are experienced as stressful. The 6-item negative subscale has a range of scores from zero to 24. Higher scores are worse outcomes. | Baseline, 12, and 24 weeks | |
| Secondary | Perceived Stress Scale (Positive) | The Perceived Stress Scale examines the degree to which situations are experienced as stressful. The 4-item positive subscale has a range of scores from zero to 16. Higher scores are better outcomes. | Baseline, 12, and 24 weeks | |
| Secondary | Center for Epidemiologic Studies Depression Scale | The Center for Epidemiologic Studies Depression Scale (CESD) measures depressive symptoms experienced in the past week.
The minimum value is zero and the maximum value is sixty. Four items were reverse coded and higher scores indicated worse outcomes. |
Baseline, 12, and 24 weeks | |
| Secondary | Parenting Sense of Competence Scale (Satisfaction) | The Parent Sense of Competency Scale measures satisfaction and self-efficacy in their parenting role. The 9-item satisfaction subscale has a range of scores from nine to fifty-four. Higher scores are better parenting self-esteem. | Baseline, 12, and 24 weeks | |
| Secondary | Parenting Sense of Competence Scale (Self-Efficacy) | The Parent Sense of Competency Scale measures satisfaction and self-efficacy in their parenting role. The 7-item self-efficacy subscale has a range of scores from seven to 42. Higher scores are better parenting self-esteem. | Baseline, 12, and 24 weeks | |
| Secondary | Parent Behavior Checklist (Discipline) | The Parent Behavior Checklist is a measure of parenting skills and knowledge. The 10-item discipline subscale has a range of values from 1 to 4. This scale was log transformed, making the range 0 to 1.4. Higher scores mean worse outcomes. | Baseline, 12, and 24 weeks | |
| Secondary | Parent Behavior Checklist (Nurturing) | The Parent Behavior Checklist is a measure of parenting skills and knowledge. The 10-item nurturing subscale has a range of values from 1 to 4. Higher scores mean worse outcomes. | Baseline, 12, and 24 weeks | |
| Secondary | Parent Behavior Checklist (Expectations) | The Parent Behavior Checklist is a measure of parenting skills and knowledge. The 12-item expectations subscale has a range of values from 1 to 4. Higher scores mean worse outcomes. | Baseline, 12, and 24 weeks | |
| Secondary | Quality of Relationship Inventory (Support) | Measure of support, conflict, and depth of father-mother relationship. The Quality of Relationship Inventory (QRI) a self-assessment questionnaire used to determine the quality of a couple's relationship and their satisfaction with the relationship. The minimum score on the support subscale is 1 and the maximum score is 4. Higher scores mean a better outcome. | Baseline, 12, and 24 weeks | |
| Secondary | Quality of Relationship Inventory (Conflict) | Measure of support, conflict, and depth of father-mother relationship. The Quality of Relationship Inventory (QRI) a self-assessment questionnaire used to determine the quality of a couple's relationship and their satisfaction with the relationship. The minimum score on the conflict subscale is 1and the maximum score is 4. Higher scores mean a worse outcome.. | Baseline, 12, and 24 weeks | |
| Secondary | Quality of Relationship Inventory (Depth) | Measure of support, conflict, and depth of father-mother relationship. The Quality of Relationship Inventory (QRI) a self-assessment questionnaire used to determine the quality of a couple's relationship and their satisfaction with the relationship. The minimum score on the depth subscale is 1 and the maximum score is 4. Higher scores mean a better outcome. | Baseline, 12, and 24 weeks | |
| Secondary | Behavior Assessment System for Children 3rd Ed (Aggression) | The Behavior Assessment System for Children (BASC) is a measure of adaptive and problem behaviors in community and home settings. The aggression subscale measures the tendency to act in a hostile manner (either verbal or physical) that is threatening to others. The raw scores are converted to T-Scores with a population mean of 50 and standard deviation of 10. Higher scores mean a worse outcome. Scores 70 and above are considered clinically significant level. | Baseline, 12, and 24 weeks | |
| Secondary | Behavior Assessment System for Children 3rd Ed (Attention) | The Behavior Assessment System for Children (BASC) is a measure of adaptive and problem behaviors in community and home settings. The attention subscale measures he tendency to be easily distracted and unable to concentrate more than momentarily. The raw scores are converted to T-Scores with a population mean of 50 and standard deviation of 10. Higher scores mean a worse outcome. Scores 70 and above are considered clinically significant level. | Baseline, 12, and 24 weeks | |
| Secondary | Behavior Assessment System for Children 3rd Ed (Depression) | The Behavior Assessment System for Children (BASC) is a measure of adaptive and problem behaviors in community and home settings. The depression subscale measures feelings of unhappiness, sadness, and stress that may result in an inability to carry out everyday activities or may bring on thoughts of suicide. The raw scores are converted to T-Scores with a population mean of 50 and standard deviation of 10. Higher scores mean a worse outcome. Scores 70 and above are considered clinically significant level. | Baseline, 12, and 24 weeks | |
| Secondary | Behavior Assessment System for Children 3rd Ed (Hyperactivity) | The Behavior Assessment System for Children (BASC) is a measure of adaptive and problem behaviors in community and home settings. The hyperactivity subscale measures the tendency to be overly active, rush through work or activities, and act without thinking. The raw scores are converted to T-Scores with a population mean of 50 and standard deviation of 10. Higher scores mean a worse outcome. Scores 70 and above are considered clinically significant level. | Baseline, 12, and 24 weeks | |
| Secondary | Tolerance For Disagreement | The degree of tolerance of interpersonal disagreement. The minimum score is 15 and the maximum score is 75. Higher scores mean a better outcome. | Baseline, 12, and 24 weeks | |
| Secondary | Personal Problem Solving Inventory - Efficacy | The Perceived Problem Solving Inventory subscale measures perceived efficacy in one's own ability to solve problems. The minimum score is 1 and the maximum score is 6 for each of the 7 items. The total range of scores for this subscale is from 1 to 6. Higher scores mean a worse outcome. | Baseline, 12, and 24 weeks | |
| Secondary | Personal Problem Solving Inventory - Skills | The Personal Problem Solving Inventory measures perceived skills in one's own ability to solve problems. The minimum score is 1 and the maximum score is 6 for each of the 9 items on this subscale. Total range of scores for the scale are 1 to 6. Higher scores mean a worse outcome. | Baseline, 12, and 24 weeks |