Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06410118
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-10
First Post:
2024-05-05
Brief Title:
The DreamChanger Intervention in Combination With Imagery Rehearsal Therapy for Childrens Nightmares
Sponsor:
Tel Aviv University
Organization:
Tel Aviv University
Study Overview
Official Title:
Efficacy of the DreamChanger Intervention in Combination With Imagery Rehearsal Therapy to Reduce Nightmares in Children
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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:
None
Brief Summary:
This clinical trial will test the efficacy of parent-delivered DreamChanger Intervention in combination with Imagery Rehearsal Therapy IRT for reducing the frequency and severity of nightmares in children aged 3-10 Children will be randoimized to either the combined intervention or to a waitlist control groupThe intervention will include providing children with the DreamChanger remote and providing parents with instructional videos explaining how to use the device along with the IRT strategy to address nightmares
At baseline mid-treatment and post-treatment parents in both groups will complete questionnaires asking about the childs nightmares sleep externalizing and internalizing symptoms PTSD symptoms demographic characteristics and parent sleep and distress Parents in the intervention group will also be asked to complete questionnaires regarding their compliance and satisfaction with the intervention as well as a 3-month follow-up assessment
At baseline mid-treatment and post-treatment parents in both groups will complete questionnaires asking about the childs nightmares sleep externalizing and internalizing symptoms PTSD symptoms demographic characteristics and parent sleep and distress Parents in the intervention group will also be asked to complete questionnaires regarding their compliance and satisfaction with the intervention as well as a 3-month follow-up assessment
Detailed Description:
Nightmares characterized as distressing dreams often leading to awakening are relatively common in young children However approximately 3-6 of children endure recurrent nightmares occurring at least once per week causing significant distress and impairment These persistent nightmares can be idiopathic or post-traumatic and may be linked to conditions such as nightmare disorder or post-traumatic stress disorder PTSD Children experiencing recurrent nightmares face an elevated risk for various maladaptive consequences including reduced sleep quality and quantity heightened nocturnal anxiety and challenges in emotional social and academic functioning Moreover parents often experience disruptions in their own sleep which may lead to adverse health outcomes Hence the demand for effective interventions to mitigate the multifaceted burdens associated with recurrent nightmares is pronounced
The most established intervention for children struggling with recurrent nightmares is Imagery Rehearsal Therapy IRT This approach aims to diminish the frequency and intensity of nightmares by encouraging children to engage with and modify the content of their nightmares through visualization and rehearsal techniques Studies assessing the efficacy of IRT in children have demonstrated significant reductions in nightmare frequency and associated distress following treatment However the evidence base for this intervention remains limited with only one small-scale N20 randomized controlled trial RCT conducted in children to date Correspondingly there is a critical need for further research to evaluate treatment effectiveness in children
Furthermore despite the promise of IRT in reducing nightmare frequency and intensity approximately 30 of children do not sufficiently benefit from treatment This underscores the necessity to refine and tailor this intervention to better address the characteristics of children To date research has yet to explore the potential advantages of augmenting IRT with additional components The DreamChanger intervention offers a novel approach specifically designed for young children experiencing recurrent nightmares Utilizing a remote-control-like device emitting a soft light this cognitive intervention empowers children to change the channel of their dreams fostering a sense of mastery and control A recent RCT demonstrated the efficacy of the DreamChanger in reducing nightmares and anxiety in young children Building upon these findings we posit that combining IRT with the DreamChanger may enhance treatment outcomes Encouraging children to utilize the DreamChanger remote during the rehearsal of alternative dream scenarios may establish associations between the remote and alternative dream imagery potentially improving the mental accessibility of imagery when using the remote at night Thus the DreamChanger has the potential to augment IRT by further stimulating the childs imagination and sense of mastery while also facilitating the rehearsal and accessibility of alternative dream imagery
This study seeks to advance scientific knowledge regarding interventions for pediatric nightmares by examining the efficacy of a novel treatment approach - a combination of IRT with the DreamChanger intervention - to alleviate recurrent nightmares and improve sleep quality in young children This augmented intervention will be compared to a waitlist control group in an RCT The research plan is based on an RCT design with 2 arms intervention vs waitlist control and assessment points at baseline mid-treatment post-treatment and for the intervention group - an additional 3-month follow-up
The most established intervention for children struggling with recurrent nightmares is Imagery Rehearsal Therapy IRT This approach aims to diminish the frequency and intensity of nightmares by encouraging children to engage with and modify the content of their nightmares through visualization and rehearsal techniques Studies assessing the efficacy of IRT in children have demonstrated significant reductions in nightmare frequency and associated distress following treatment However the evidence base for this intervention remains limited with only one small-scale N20 randomized controlled trial RCT conducted in children to date Correspondingly there is a critical need for further research to evaluate treatment effectiveness in children
Furthermore despite the promise of IRT in reducing nightmare frequency and intensity approximately 30 of children do not sufficiently benefit from treatment This underscores the necessity to refine and tailor this intervention to better address the characteristics of children To date research has yet to explore the potential advantages of augmenting IRT with additional components The DreamChanger intervention offers a novel approach specifically designed for young children experiencing recurrent nightmares Utilizing a remote-control-like device emitting a soft light this cognitive intervention empowers children to change the channel of their dreams fostering a sense of mastery and control A recent RCT demonstrated the efficacy of the DreamChanger in reducing nightmares and anxiety in young children Building upon these findings we posit that combining IRT with the DreamChanger may enhance treatment outcomes Encouraging children to utilize the DreamChanger remote during the rehearsal of alternative dream scenarios may establish associations between the remote and alternative dream imagery potentially improving the mental accessibility of imagery when using the remote at night Thus the DreamChanger has the potential to augment IRT by further stimulating the childs imagination and sense of mastery while also facilitating the rehearsal and accessibility of alternative dream imagery
This study seeks to advance scientific knowledge regarding interventions for pediatric nightmares by examining the efficacy of a novel treatment approach - a combination of IRT with the DreamChanger intervention - to alleviate recurrent nightmares and improve sleep quality in young children This augmented intervention will be compared to a waitlist control group in an RCT The research plan is based on an RCT design with 2 arms intervention vs waitlist control and assessment points at baseline mid-treatment post-treatment and for the intervention group - an additional 3-month follow-up
Study Oversight
Has Oversight DMC:
None
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?:
None
Is an FDA AA801 Violation?:
None