Ignite Creation Date:
2025-12-25 @ 4:55 AM
Ignite Modification Date:
2025-12-26 @ 3:55 AM
Study NCT ID:
NCT07207018
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-10-03
First Post:
2025-02-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Early Intervention After Traumatic Exposure in Children and Adolescents
Sponsor:
University Hospital, Montpellier
Organization:
Study Overview
Official Title:
Early Intervention After Traumatic Exposure in Children and Adolescents: a Randomized Controlled Trial of the Effectiveness of Child and Family Traumatic Stress Intervention (CFTSI).
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ADAPT
Brief Summary:
The aim of this interventional research is to evaluate the effectiveness of CFTSI in reducing post-traumatic symptoms measured using the CPC, child version, at the end of CFTSI treatment in children and adolescents aged between 7 and 17 years, exposed to an ET in the last 3 months. The main question(s) it aims to answer \[is/are\]:
* CFTSI reduces posttraumatic Child Posttraumatic Stress Checklist (CPC) scores in children exposed to ET, both immediatly after completion of the CFTSI and at 3 months after completion.
* CFTSI reduces post-traumatic scores in parents on the PTSD Checklist for DSM5 (PCL), both immediatly after completion of the CFTSI and at 3 months after completion.
* researchers will compare the reduction in post-traumatic symptoms between participants receiving CFTSI and those receiving non-specific child-centred psychological support. Symptoms will be assessed using the PCL in parents and the CPC in children and adolescents, immediately after completion of the program and again at 3 months after completion.
The participants will be randomised into two groups, one that will undergo CFTSI and one that will undergo supportive psychological therapy. Each participant will receive one session per week over five weeks, and possibly 1 to 3 additional sessions if necessary over a further three weeks, and will then be reviewed three months later.
* CFTSI reduces posttraumatic Child Posttraumatic Stress Checklist (CPC) scores in children exposed to ET, both immediatly after completion of the CFTSI and at 3 months after completion.
* CFTSI reduces post-traumatic scores in parents on the PTSD Checklist for DSM5 (PCL), both immediatly after completion of the CFTSI and at 3 months after completion.
* researchers will compare the reduction in post-traumatic symptoms between participants receiving CFTSI and those receiving non-specific child-centred psychological support. Symptoms will be assessed using the PCL in parents and the CPC in children and adolescents, immediately after completion of the program and again at 3 months after completion.
The participants will be randomised into two groups, one that will undergo CFTSI and one that will undergo supportive psychological therapy. Each participant will receive one session per week over five weeks, and possibly 1 to 3 additional sessions if necessary over a further three weeks, and will then be reviewed three months later.
Detailed Description:
Individuals and populations worldwide are exposed to extremely high rates of maltreatment, violence, sexual and physical abuse, bullying, severe accidents, and exposure to other traumatic events (TE) such as natural disasters, terrorist attacks, war, and forced migration. The Diagnostic and Statistical Manual of Mental Disorders (DSM-5) defines a traumatic event as any situation involving "actual or threatened death, serious injury, or sexual violence". A report based on epidemiological data from 24 different countries found that 70% of the populations studied worldwide report exposure to at least one TE in their lifetime. This exposure is more frequently observed among children, adolescents, and young adults, with 60% of youth under 18 having experienced at least one TE in the past year.
Childhood traumatic exposure is associated with an increased risk of developing Post-Traumatic Stress Disorder (PTSD) as well as other psychiatric disorders (depression, anxiety, suicidal behavior, addictions) and somatic issues that persist into adulthood. Psychological trauma can interfere with a child's psycho-affective, cognitive, and identity development, as well as with learning processes. Furthermore, trauma also affects the child's environment and family, disrupting family dynamics, relationships within the nuclear and extended family, as well as the mental health of parents and siblings. Traumatic exposure particularly impacts children and adolescents with pre-existing neurodevelopmental disorders (NDD) (e.g., Attention Deficit Hyperactivity Disorder, Autism Spectrum Disorder, specific learning disorders) and complicates their responses and engagement with their usual treatment. This is especially critical, as children with NDD are at a higher risk than the general population for maltreatment, abuse, and/or bullying .
A meta-analysis of 27 studies on PTSD in children aged 5 to 18 shows that for some exposed individuals, there is spontaneous resolution in the months following the traumatic exposure: the prevalence of PTSD in the acute phase, one month after TE, was 21%, decreasing to 15% at three months, then to 12% and 11% at six months and one year after the TE, respectively. However, given the high rates of exposure, the percentage of children at risk of developing PTSD or associated disorders remains significant. Additionally, symptoms appearing in the acute phase, such as intrusive thoughts and irritability, cause distress for the child and their family and may lead to functional impairment, interfering with optimal development.
It is currently understood that multiple individual and contextual factors before and after traumatic exposure can either facilitate or hinder the remission of acute stress symptoms and the development of PTSD and other associated disorders. A history of traumatic exposure or neurodevelopmental disorder, younger age at the time of the TE, female gender, the nature of the TE involving intentional violence by one person against another, and post-traumatic symptoms in parents are all associated with more severe post-traumatic reactions, a higher risk of developing PTSD, and a lower response to proposed treatments. Furthermore, social and family support has been shown to be a key protective factor, facilitating the management of post-traumatic reactions following a TE and preventing the onset of PTSD in children and adolescents. It is well established that parents or primary attachment figures play a crucial role in helping children build resilience in the face of adversity. A literature meta-analysis examining the role of parental behavior in the development of PTSD in children revealed that negative parenting (hostility, overprotection) is significantly associated with child PTSD. Additionally, involvement in (or reactions to) events that impact their children can be traumatic for parents themselves, which may, in turn, affect their ability to effectively support their child at a time when the child is particularly vulnerable.
There is thus a crucial need for early and effective interventions to reduce the functional impact on development and to optimize the adaptive capacities of parents and children. Detecting traumatic situations and providing care in the wake of acute traumatic exposure or upon discovery of such exposure is essential to ensure favorable post-traumatic adjustment and prevent progression to psychotraumatic syndrome and other associated disorders, in addition to alleviating acute distress and functional impact.
Contrary to the abundant literature on established PTSD therapies, which are well-documented, there is limited data on early interventions within the first forty five days following exposure to traumatic events. The investigators conducted a scoping review on this subject to identify early interventions that have been tested and validated following traumatic exposure in children and adolescents. A promising intervention that emerged from the investigators literature review is the CFTSI (Child and Family Traumatic Stress Intervention), a brief early intervention developed at the Yale Child Study Center for children aged seven to seventeen who have recently experienced a traumatic event (TE). CFTSI is a family-centered intervention lasting five to eight sessions, aiming to strengthen parental support for the child by facilitating the identification of the child's typical responses to TE, improving communication between the child and the parent, and teaching coping strategies and behavioral interventions to both parents and children to reduce acute post-traumatic reactions.
The model has been implemented with children exposed to various TEs, including sexual abuse, domestic and community violence, road accidents, animal bites, and other injuries, but not chronic, ongoing TEs, such as child maltreatment or war contexts. CFTSI can be implemented within three months following exposure to a TE. In a randomized controlled trial (RCT) comparing CFTSI to a five-session psychoeducational and non-specific psychological support model, Berkowitz et al. found that children in the CFTSI group had fewer full and partial PTSD diagnoses compared to the control group three months post-intervention. Additionally, a multicenter study without a control group assessing CFTSI's effectiveness in 1,190 families found a significant reduction in acute post-traumatic symptoms in children post-CFTSI. This same study found that symptom reduction was independent of age, gender, ethnicity, number of previous traumatic exposures, type of event, or time elapsed between the traumatic event and the start of CFTSI (e.g., after a few days or weeks).
Similarly, a multisite meta-analysis examining CFTSI's effectiveness across various centers in the United States indicated a significant improvement in post-traumatic symptoms in adult parents who participated in CFTSI with their children. This is one of the few studies that specifically evaluated the effect of early intervention after a child's exposure to a TE on parental symptoms and mental health. These results align with research establishing correlations between parental and child psychopathology, as the family environment and parental functioning systematically influence the association between traumatic exposure and its consequences for children. Additionally, involvement in events that affect their children can be traumatic for parents themselves, which may affect their ability to effectively support a child rendered vulnerable after TE exposure. Parents experiencing significant emotional distress are less able to demonstrate a sense of stability and security to the child and to support the child in their recovery. Conversely, when parents cope effectively, this can facilitate the child's adjustment post-TE by modeling effective coping skills, maintaining balance through routine and regulation, and instilling self-efficacy and relational skills. This underscores the importance of interventions aimed at strengthening parental capacities following the child's exposure to a traumatic event and providing additional support to parents significantly affected by their child's TE exposure, especially as parental ability to support their children is linked to their own level of emotional distress.
A recent study evaluating the effectiveness of CFTSI's online format showed significant reductions in child and parent PTSD symptoms before and after the intervention, even among children with chronic traumatic exposure.
The investigators have thus begun implementing CFTSI in routine practice at the Montpellier Child/Adolescent Regional Center for Psychotrauma (CRP) within the Child and Adolescent Psychological Medicine Service, following certification training with Yale University: two psychiatric nurses, three psychologists, and a child psychiatrist have already been trained. However, while Berkowitz's study was indeed an RCT evaluating CFTSI's effectiveness in preventing the onset of PTSD diagnosis in children three months post-CFTSI, no RCTs have yet been conducted, in France or elsewhere, assessing CFTSI's effectiveness in reducing acute symptoms in children and parents (thus post-CFTSI) and the persistence of these effects at three months, despite acute stress and parental symptoms remaining a significant source of suffering for children and their families.
Conducting an RCT would provide a high level of evidence for CFTSI and promote it regionally and nationally as an early intervention following traumatic exposure in children and adolescents, filling a gap in validated interventions at this level, which would alleviate children's post-traumatic stress and their parents' symptoms by enhancing parental skills. Furthermore, the investigators conducted a qualitative study with parents of adolescents aged 11 to 17 who had been exposed to a TE in the past three months to explore their experiences and perceived needs during the peri-traumatic period. The investigators' findings confirmed that parents struggled to understand their children's reactions, lacked explanations and knowledge about post-traumatic stress, expressed a sense of failure and parental inefficacy in the face of their child's suffering, hesitated on the best approach to conflicting needs, felt considerable shame and guilt, and tended to alternate between avoidant educational attitudes and coercive parenting, which strained their relationship with their child and led to conflicting dynamics. These qualitative data indicate the need to offer these parents an early, validated family intervention following their child's traumatic exposure to strengthen family support, a major protective factor.
The investigators study aims to evaluate, through a randomized controlled trial, the following objectives: (i) Effectiveness of CFTSI in reducing post-traumatic symptoms in children and adolescents aged 7 to 17 who have been exposed to traumatic events (TE) within the past three months, assessed both immediately after completion of the program and at 3 months following completion ; (ii) Impact of CFTSI on parental post-traumatic symptoms, assessed both immediately after completion of the program and at 3 months following completion ; (iii) Mediators of response to CFTSI among youth.
Childhood traumatic exposure is associated with an increased risk of developing Post-Traumatic Stress Disorder (PTSD) as well as other psychiatric disorders (depression, anxiety, suicidal behavior, addictions) and somatic issues that persist into adulthood. Psychological trauma can interfere with a child's psycho-affective, cognitive, and identity development, as well as with learning processes. Furthermore, trauma also affects the child's environment and family, disrupting family dynamics, relationships within the nuclear and extended family, as well as the mental health of parents and siblings. Traumatic exposure particularly impacts children and adolescents with pre-existing neurodevelopmental disorders (NDD) (e.g., Attention Deficit Hyperactivity Disorder, Autism Spectrum Disorder, specific learning disorders) and complicates their responses and engagement with their usual treatment. This is especially critical, as children with NDD are at a higher risk than the general population for maltreatment, abuse, and/or bullying .
A meta-analysis of 27 studies on PTSD in children aged 5 to 18 shows that for some exposed individuals, there is spontaneous resolution in the months following the traumatic exposure: the prevalence of PTSD in the acute phase, one month after TE, was 21%, decreasing to 15% at three months, then to 12% and 11% at six months and one year after the TE, respectively. However, given the high rates of exposure, the percentage of children at risk of developing PTSD or associated disorders remains significant. Additionally, symptoms appearing in the acute phase, such as intrusive thoughts and irritability, cause distress for the child and their family and may lead to functional impairment, interfering with optimal development.
It is currently understood that multiple individual and contextual factors before and after traumatic exposure can either facilitate or hinder the remission of acute stress symptoms and the development of PTSD and other associated disorders. A history of traumatic exposure or neurodevelopmental disorder, younger age at the time of the TE, female gender, the nature of the TE involving intentional violence by one person against another, and post-traumatic symptoms in parents are all associated with more severe post-traumatic reactions, a higher risk of developing PTSD, and a lower response to proposed treatments. Furthermore, social and family support has been shown to be a key protective factor, facilitating the management of post-traumatic reactions following a TE and preventing the onset of PTSD in children and adolescents. It is well established that parents or primary attachment figures play a crucial role in helping children build resilience in the face of adversity. A literature meta-analysis examining the role of parental behavior in the development of PTSD in children revealed that negative parenting (hostility, overprotection) is significantly associated with child PTSD. Additionally, involvement in (or reactions to) events that impact their children can be traumatic for parents themselves, which may, in turn, affect their ability to effectively support their child at a time when the child is particularly vulnerable.
There is thus a crucial need for early and effective interventions to reduce the functional impact on development and to optimize the adaptive capacities of parents and children. Detecting traumatic situations and providing care in the wake of acute traumatic exposure or upon discovery of such exposure is essential to ensure favorable post-traumatic adjustment and prevent progression to psychotraumatic syndrome and other associated disorders, in addition to alleviating acute distress and functional impact.
Contrary to the abundant literature on established PTSD therapies, which are well-documented, there is limited data on early interventions within the first forty five days following exposure to traumatic events. The investigators conducted a scoping review on this subject to identify early interventions that have been tested and validated following traumatic exposure in children and adolescents. A promising intervention that emerged from the investigators literature review is the CFTSI (Child and Family Traumatic Stress Intervention), a brief early intervention developed at the Yale Child Study Center for children aged seven to seventeen who have recently experienced a traumatic event (TE). CFTSI is a family-centered intervention lasting five to eight sessions, aiming to strengthen parental support for the child by facilitating the identification of the child's typical responses to TE, improving communication between the child and the parent, and teaching coping strategies and behavioral interventions to both parents and children to reduce acute post-traumatic reactions.
The model has been implemented with children exposed to various TEs, including sexual abuse, domestic and community violence, road accidents, animal bites, and other injuries, but not chronic, ongoing TEs, such as child maltreatment or war contexts. CFTSI can be implemented within three months following exposure to a TE. In a randomized controlled trial (RCT) comparing CFTSI to a five-session psychoeducational and non-specific psychological support model, Berkowitz et al. found that children in the CFTSI group had fewer full and partial PTSD diagnoses compared to the control group three months post-intervention. Additionally, a multicenter study without a control group assessing CFTSI's effectiveness in 1,190 families found a significant reduction in acute post-traumatic symptoms in children post-CFTSI. This same study found that symptom reduction was independent of age, gender, ethnicity, number of previous traumatic exposures, type of event, or time elapsed between the traumatic event and the start of CFTSI (e.g., after a few days or weeks).
Similarly, a multisite meta-analysis examining CFTSI's effectiveness across various centers in the United States indicated a significant improvement in post-traumatic symptoms in adult parents who participated in CFTSI with their children. This is one of the few studies that specifically evaluated the effect of early intervention after a child's exposure to a TE on parental symptoms and mental health. These results align with research establishing correlations between parental and child psychopathology, as the family environment and parental functioning systematically influence the association between traumatic exposure and its consequences for children. Additionally, involvement in events that affect their children can be traumatic for parents themselves, which may affect their ability to effectively support a child rendered vulnerable after TE exposure. Parents experiencing significant emotional distress are less able to demonstrate a sense of stability and security to the child and to support the child in their recovery. Conversely, when parents cope effectively, this can facilitate the child's adjustment post-TE by modeling effective coping skills, maintaining balance through routine and regulation, and instilling self-efficacy and relational skills. This underscores the importance of interventions aimed at strengthening parental capacities following the child's exposure to a traumatic event and providing additional support to parents significantly affected by their child's TE exposure, especially as parental ability to support their children is linked to their own level of emotional distress.
A recent study evaluating the effectiveness of CFTSI's online format showed significant reductions in child and parent PTSD symptoms before and after the intervention, even among children with chronic traumatic exposure.
The investigators have thus begun implementing CFTSI in routine practice at the Montpellier Child/Adolescent Regional Center for Psychotrauma (CRP) within the Child and Adolescent Psychological Medicine Service, following certification training with Yale University: two psychiatric nurses, three psychologists, and a child psychiatrist have already been trained. However, while Berkowitz's study was indeed an RCT evaluating CFTSI's effectiveness in preventing the onset of PTSD diagnosis in children three months post-CFTSI, no RCTs have yet been conducted, in France or elsewhere, assessing CFTSI's effectiveness in reducing acute symptoms in children and parents (thus post-CFTSI) and the persistence of these effects at three months, despite acute stress and parental symptoms remaining a significant source of suffering for children and their families.
Conducting an RCT would provide a high level of evidence for CFTSI and promote it regionally and nationally as an early intervention following traumatic exposure in children and adolescents, filling a gap in validated interventions at this level, which would alleviate children's post-traumatic stress and their parents' symptoms by enhancing parental skills. Furthermore, the investigators conducted a qualitative study with parents of adolescents aged 11 to 17 who had been exposed to a TE in the past three months to explore their experiences and perceived needs during the peri-traumatic period. The investigators' findings confirmed that parents struggled to understand their children's reactions, lacked explanations and knowledge about post-traumatic stress, expressed a sense of failure and parental inefficacy in the face of their child's suffering, hesitated on the best approach to conflicting needs, felt considerable shame and guilt, and tended to alternate between avoidant educational attitudes and coercive parenting, which strained their relationship with their child and led to conflicting dynamics. These qualitative data indicate the need to offer these parents an early, validated family intervention following their child's traumatic exposure to strengthen family support, a major protective factor.
The investigators study aims to evaluate, through a randomized controlled trial, the following objectives: (i) Effectiveness of CFTSI in reducing post-traumatic symptoms in children and adolescents aged 7 to 17 who have been exposed to traumatic events (TE) within the past three months, assessed both immediately after completion of the program and at 3 months following completion ; (ii) Impact of CFTSI on parental post-traumatic symptoms, assessed both immediately after completion of the program and at 3 months following completion ; (iii) Mediators of response to CFTSI among youth.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: