- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07676240
An Adapted Evidence-Based Coaching Program for Fathers and Their Young Children in the Context of Home Visiting
Randomized Controlled Trial of an Adapted Evidence-Based Coaching Program for Fathers and Their Young Children in the Context of Home Visiting
Father-child pairs (N=200; children ages 12-36 months) will be randomized to FIND-F or a waitlist control group. Assessments comparing the two groups will occur at baseline, end of program, and 6 months post-program. Our aims include:
Aim 1: Evaluate the main impacts of FIND-F on the primary program target (fathers' supportive parenting) and related child and parent outcomes.
Aim 2. Identify mechanisms of FIND-F's intervention effects.
Aim 3. Examine variation by select child, father, and program measures.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
The proposed work will achieve three specific aims in the context of a two-arm, fully powered RCT. This will be one of the first large-scale RCTs focused on evaluating the impacts and underlying theory of a nurturing fathering program.
As fathers enroll, they will be randomly assigned to either FIND-F (Group A) or a waitlist control group (Group B). A waitlist control group design is proposed based on community views that it would be unethical to deny consenting, eligible fathers access to FIND-F. This is a common approach in early childhood evaluations to increase program access. Both groups will be assessed at three time points: baseline, endpoint, and 6-Month follow-up. After the 6-month follow-up assessment, the waitlist group will be given the opportunity to receive FIND-F.
Each FIND-F session focuses on a specific element of a serve and return interaction, using the edited films to support fathers in learning about that element. The five elements are: (a) Sharing Child's Focus- when the father notices what the child is interested in and puts his attention there too; (b) Supporting and Encouraging- when the father responds to the child's "serve" through acknowledging, soothing, comforting, or praising the child; (c) Naming - when the father provides a word or explanation for what the child is seeing, doing, or feeling; (d) Back and Forth- when the father and child continue interacting in a longer back-and-forth manner; and (e) Endings and Beginnings- when a child signals the end of an activity, a new serve and return interaction begins, and the father follows the child's lead.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Holly Schindler, PhD
- Número de teléfono: 206-616-0853
- Correo electrónico: hschindl@uw.edu
Ubicaciones de estudio
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Washington
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Seattle, Washington, Estados Unidos, 98125
- Reclutamiento
- Akin
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Contacto:
- FIND Program Manager
- Número de teléfono: 206-695-3200
- Correo electrónico: novina.maree@akinfamily.org
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Identify as a father
- Speak English or Spanish
- Have a child between the ages of 12-36 months who lives with you
- Be enrolled in Akin services
Exclusion Criteria:
- No additional exclusion criteria
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Filming Interactions to Nurture development (FIND)
This group of fathers will receive FIND, a 6-session manualized program.
FIND with fathers is delivered through flexible home visits, targets warm and responsive father-child interactions, and uses video recordings to emphasize each father's parenting strengths in the context of everyday caretaking moments.
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FIND-F is a 6-session manualized program that begins with the home visitor taking a 10-minute video of the father and child engaging in an everyday activity (e.g., playing, having a snack).
Then, that video is carefully edited to emphasize the specific strengths observed in the father-child interactions.
The brief, edited videos are then reviewed with the father the following week.
In reviewing the video clips, the home visitor uses micro-analytic narration, highlighting the frame-by-frame sequence of events that fosters the child's healthy development.
In this way, the goal of FIND-F is to shift the father's perceptions of himself and his child, enabling the father to become increasingly responsive and encouraging.
Home visitors also provide opportunities for fathers to comment and ask questions throughout the video review.
Otros nombres:
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Sin intervención: Waitlist Control
This group will serve as the control group.
After all data is collected, they will be offered FIND.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Fathers' Supportive Parenting Practices
Periodo de tiempo: From enrollment to the end of treatment at 7 weeks
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Fathers' supportive parenting skills will be observed through videotaped father-child interactions.
Fathers will be provided with a standard bag of toys and asked to "share these toys with your child as you normally would."
Each set of toys (one set for pretest, one for endpoint, and one for follow-up) has been carefully selected with input from home visitors about which toys could support interactions across the age range in our study.
The first 10 minutes of the videotaped interactions will be coded using the PICCOLO-D (Dads' Parenting Interactions with Children Checklist of Observations Linked to Outcomes).
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From enrollment to the end of treatment at 7 weeks
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Fathers' Supportive Parenting Practices
Periodo de tiempo: 6 months after end of treatment
|
Fathers' supportive parenting skills will be observed through videotaped father-child interactions.
Fathers will be provided with a standard bag of toys and asked to "share these toys with your child as you normally would."
Each set of toys (one set for pretest, one for endpoint, and one for follow-up) has been carefully selected with input from home visitors about which toys could support interactions across the age range in our study.
The first 10 minutes of the videotaped interactions will be coded using the PICCOLO-D (Dads' Parenting Interactions with Children Checklist of Observations Linked to Outcomes).
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6 months after end of treatment
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Parenting Stress
Periodo de tiempo: From enrollment to the end of treatment at 7 weeks
|
Fathers' parenting stress will be measured using the Parenting Stress Index-Short Form (PSI-SF) (Loyd & Abidin, 1985).
The PSI-SF asks parents of children birth to 12 years old to indicate their level of agreement or disagreement about 36 statements on a 5-point scale regarding their level of stress, how difficult their child is to manage, and whether parenting fits their expectations.
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From enrollment to the end of treatment at 7 weeks
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Father Identity
Periodo de tiempo: From enrollment to the end of treatment at 7 weeks
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Fathers' identity related to the fathering role will be measured with The Pie, which instructs fathers to create a graphical representation of their psychological investment in the different aspects of their lives (Cowan & Cowan, 1991).
More specifically, fathers will be asked to list the main roles in their lives and then divide a circle (pie) into pieces so that the size of each piece represents the importance of that role.
In this study, the degrees of the circle that represent fathering or parenting will be recorded.
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From enrollment to the end of treatment at 7 weeks
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Children's Behavior Problems and Social and Emotional Competence
Periodo de tiempo: From enrollment to the end of treatment at 7 weeks
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We will use the Brief Infant-Toddler Social-Emotional Assessment (BITSEA) to measure both behavior problems and social and emotional competence (Briggs-Gowan, Carter, McCarthy, Augustyn, & Clark, 2013).
The BITSEA is a standardized parent-reported measure of 42 items.
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From enrollment to the end of treatment at 7 weeks
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Father Involvement
Periodo de tiempo: From enrollment to the end of treatment at 7 weeks
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Fathers' involvement will be captured through the Father Engagement Scale (Dyer et al., 2015).
This measure is for use with fathers of children 12 months to 6 years and asks fathers 10 questions on a 5-point scale about the frequency of their engagement in activities such as playing with toys, hugging their child, talking with their child, and encouraging their child.
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From enrollment to the end of treatment at 7 weeks
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Parenting Stress
Periodo de tiempo: 6 months after end of treatment
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Fathers' parenting stress will be measured using the Parenting Stress Index-Short Form (PSI-SF) (Loyd & Abidin, 1985).
The PSI-SF asks parents of children birth to 12 years old to indicate their level of agreement or disagreement about 36 statements on a 5-point scale regarding their level of stress, how difficult their child is to manage, and whether parenting fits their expectations.
|
6 months after end of treatment
|
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Father Identity
Periodo de tiempo: 6 months after end of treatment
|
Fathers' identity related to the fathering role will be measured with The Pie, which instructs fathers to create a graphical representation of their psychological investment in the different aspects of their lives (Cowan & Cowan, 1991).
More specifically, fathers will be asked to list the main roles in their lives and then divide a circle (pie) into pieces so that the size of each piece represents the importance of that role.
In this study, the degrees of the circle that represent fathering or parenting will be recorded.
|
6 months after end of treatment
|
|
Children's Behavior Problems and Social and Emotional Competence
Periodo de tiempo: 6 months after end of treatment
|
We will use the Brief Infant-Toddler Social-Emotional Assessment (BITSEA) to measure both behavior problems and social and emotional competence (Briggs-Gowan, Carter, McCarthy, Augustyn, & Clark, 2013).
The BITSEA is a standardized parent-reported measure of 42 items.
|
6 months after end of treatment
|
|
Father Involvement
Periodo de tiempo: 6 months after end of treatment
|
Fathers' involvement will be captured through the Father Engagement Scale (Dyer et al., 2015).
This measure is for use with fathers of children 12 months to 6 years and asks fathers 10 questions on a 5-point scale about the frequency of their engagement in activities such as playing with toys, hugging their child, talking with their child, and encouraging their child.
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6 months after end of treatment
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Holly Schindler, PhD, University of Washington
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- STUDY00022913
- R01HD117812-01 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Marco de tiempo para compartir IPD
Criterios de acceso compartido de IPD
Data will be for public use (i.e., not restricted). ICPSR users must agree to the following per ICPSR guidelines:
- The datasets are to be used solely for statistical analysis and reporting aggregated information.
- The confidentiality of research participants is to be guarded in all ways.
- Anything that can potentially breach participants' confidentiality is to be reported promptly to ICPSR.
- The data are not to be redistributed or sold to others without the written agreement of ICPSR.
- The user will inform ICPSR of the use of the data in books, articles, and other forms of publication.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
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