Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06535516
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
None
First Post:
2024-07-17
Brief Title:
Infusing Diversity to Enhance Adapted Treatment IDEA
Sponsor:
None
Organization:
None
Study Overview
Official Title:
TRANSFORM Translational Research That Adapts New Science FOR Maltreatment Prevention Project 3
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IDEA
Brief Summary:
IDEA is integrated into the TRANSFORM Center to promote translation of research findings into clinical interventions to inform the next generation of research on child abuse and neglect CAN and to facilitate dissemination of research and practice knowledgeskills to varied stakeholders Exposure to CAN frequently results in long-term detrimental effects on mental health For youth who have experienced racial and ethnic marginalization the trauma associated with CAN may be compounded by stress and trauma deriving from experiences of racism discrimination and other forms of oppression Interventions to address racial stress for symptomatic youth receiving mental health services are lacking and use of mental health services that are acceptable to Black families are too often misaligned with their representation in the population in general and overrepresentation in the child welfare system specifically Incorporating support for families in enhancing racial socialization and coping skills specific to addressing racial stress and trauma has relevance for public health where systemic racism is acknowledged as a core social determinant of health posing a threat to public health Although Trauma-Focused Cognitive Behavioral Therapy TF-CBT is an evidence-based treatment for children who have experienced CAN determining best practices for implementing enhanced TF-CBT with racial socialization components is urgently needed to address these gaps and provide optimal intervention for this population IDEA is a pilot study within a RE-AIMPRISM framework including Reach Effectiveness Adoption Implementation and Maintenance with emphasis on contextual factors at multiple levels of the implementation setting that will incorporate stakeholder perspectives and evaluate the incorporation of racial socialization into TF-CBT while identifying barriers and facilitators to implementation to guide future larger-scale trials
Detailed Description:
Child abuse and neglect CAN represents a pathogenic relational environment that confers significant risk for maladaptation The deleterious sequelae accompanying child abuse and neglect result in adverse physical and mental health consequences during childhood and initiate a negative developmental cascade that continues throughout the life course The proximal environment involving the nuclear family as well as more distal factors associated with the community and culture transact to undermine normal biological and psychological developmental processes in these vulnerable children For Black youth these negative sequelae are compounded by the effects of racial stress that further undermine their wellbeing and adaptive functioning Black youth are disproportionately represented within Child Protective Services CPS and child welfare systems and yet less likely to receive mental health services particularly high-quality evidence-based treatments Within families racial stress may impact developmental trajectories from pregnancy through adulthood Caregivers wellbeing and stress levels parenting practices and competence in promoting positive racial identity may influence youths development of accurate appraisal strategies and positive coping skills to protect them from racial stress Families with effective communication strategies to discuss cultural strengths navigate through racially stressful encounters and build self-esteem may be more likely to buffer the effects of racial stress on their childrens development Although evidence-based trauma treatments to address the effects of child abuse and neglect such as Trauma-Focused Cognitive Behavioral Therapy TF-CBT have demonstrated efficacy in reducing symptoms of posttraumatic stress PTSD broadly speaking they are not designed to address the specific challenges that Black youth with child abuse and neglect experiences face in counteracting both PTSD and racial stress Mental health clinicians are often unprepared to address the impact of experiences of racism and may underestimate the impact of racial stress Novel approaches are being developed that can support families in building racial socialization skills One such approach has been designed to incorporate racial socialization into a standard course of TF-CBT This pilot study will examine the feasibility and acceptability of incorporating racial socialization practices with TF-CBT to enhance outcomes for Black youth ages 10-14 who have experienced child abuse and neglect A RE-AIMPRISM framework including Reach Effectiveness Adoption Implementation and Maintenance with emphasis on contextual factors at multiple levels of the implementation setting will incorporate stakeholder perspectives and evaluate TF-CBT with integrated racial socialization to ascertain whether this approach is acceptable based on stakeholder input Additionally identification of barriers and facilitators to implementation to guide future larger-scale trials will be addressed Developing interventions to support parenting strategies that can promote positive racial socialization and racial identity for Black youth facing the combined effects of child abuse and neglect and racial stress is of high public health significance Given the lifelong cascades that accompany child abuse and neglect and racial discrimination determining best practices for improving behavioral health outcomes for Black youth who have experienced child abuse and neglect is highly significant
This IDEA-P Pilot is integrated into the TRANSFORM Center on Child Abuse and Neglect to promote translation of research findings into clinical interventions to inform the next generation of research on child abuse and neglect and to facilitate dissemination of research and practice knowledgeskills to varied stakeholders The research utilizes a developmental psychopathology perspective incorporating multiple methods within a lifespan framework and implementation science approach Exposure to child abuse and neglect frequently results in long-term detrimental effects on mental health Disproportionate representation of Black youth in the Child Protective Services CPS and child welfare system is associated with health disparities For youth who have experienced racial and ethnic marginalization the trauma associated with child abuse and neglect may be compounded by stress and trauma deriving from experiences of racism discrimination and other forms of oppression Interventions to address racial stress for symptomatic youth receiving mental health services are lacking and use of mental health services that are acceptable to Black families are too often misaligned with their representation in the population in general and overrepresentation in the child welfare system specifically Incorporating support for families in enhancing racial socialization and coping skills specific to addressing racial stress and trauma has relevance for public health where systemic racism is acknowledged as a core social determinant of health posing a threat to public health Although TF-CBT is an evidence-based treatment for children who have experienced trauma determining best practices for implementing enhanced TF-CBT with racial socialization components is urgently needed to address these gaps and provide optimal intervention for this population
The study Aims for the full project are as follows
Aim 1 From a community-based participatory research framework CBPR engage community partners and assess acceptability of racial socialization RS procedures to augment TF-CBT for Black youth ages 10-14 as well as to inform study design and implementation plans through focus groups with diverse stakeholders youth family mental health clinicians to inform Aim 2
Aim 2 Evaluate the feasibility of a pilot randomized control trial RCT testing the incorporation of racial socialization into standard TF-CBT to improve coping racial socialization and to reduce mental health symptoms in Black youth with child abuse and neglect histories
Aim 3 Investigate whether TF-CBT leads to greater improvement in mental health symptoms for Black youth with child abuse and neglect when augmented with incorporated racial socialization principles into TF-CBT
This IDEA-P Pilot is integrated into the TRANSFORM Center on Child Abuse and Neglect to promote translation of research findings into clinical interventions to inform the next generation of research on child abuse and neglect and to facilitate dissemination of research and practice knowledgeskills to varied stakeholders The research utilizes a developmental psychopathology perspective incorporating multiple methods within a lifespan framework and implementation science approach Exposure to child abuse and neglect frequently results in long-term detrimental effects on mental health Disproportionate representation of Black youth in the Child Protective Services CPS and child welfare system is associated with health disparities For youth who have experienced racial and ethnic marginalization the trauma associated with child abuse and neglect may be compounded by stress and trauma deriving from experiences of racism discrimination and other forms of oppression Interventions to address racial stress for symptomatic youth receiving mental health services are lacking and use of mental health services that are acceptable to Black families are too often misaligned with their representation in the population in general and overrepresentation in the child welfare system specifically Incorporating support for families in enhancing racial socialization and coping skills specific to addressing racial stress and trauma has relevance for public health where systemic racism is acknowledged as a core social determinant of health posing a threat to public health Although TF-CBT is an evidence-based treatment for children who have experienced trauma determining best practices for implementing enhanced TF-CBT with racial socialization components is urgently needed to address these gaps and provide optimal intervention for this population
The study Aims for the full project are as follows
Aim 1 From a community-based participatory research framework CBPR engage community partners and assess acceptability of racial socialization RS procedures to augment TF-CBT for Black youth ages 10-14 as well as to inform study design and implementation plans through focus groups with diverse stakeholders youth family mental health clinicians to inform Aim 2
Aim 2 Evaluate the feasibility of a pilot randomized control trial RCT testing the incorporation of racial socialization into standard TF-CBT to improve coping racial socialization and to reduce mental health symptoms in Black youth with child abuse and neglect histories
Aim 3 Investigate whether TF-CBT leads to greater improvement in mental health symptoms for Black youth with child abuse and neglect when augmented with incorporated racial socialization principles into TF-CBT
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None