Ignite Creation Date:
2025-12-24 @ 1:29 PM
Ignite Modification Date:
2026-01-03 @ 8:31 AM
Study NCT ID:
NCT07246395
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-24
First Post:
2025-09-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
NarraTivAS - Narrative Family Therapy in Autism Spectrum
Sponsor:
University of Coimbra
Organization:
Study Overview
Official Title:
Narrative Family Therapy in Autism Spectrum: From Clinical Neuroscience to Intervention Outcomes
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-11
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:
NarraTivAS
Brief Summary:
Autism Spectrum Disorder (ASD) is a neurodevelopmental condition characterized by difficulties in social communication and interaction, along with restricted and repetitive patterns of behavior, interests, or activities. While previous research has largely focused on individualized therapies and behavioral outcomes for people with autism, there remains a gap in understanding the broader effect on family systems functioning and the neurobiological changes that may occur following intervention.
This project aims to address that gap by characterizing families of individuals with autism, examining both individual and family-level variables, including their motivation to participate in Narrative Family Therapy. Participating families will be assigned to either an intervention group receiving Narrative Family Therapy or a control group engaged in a Game Theory-based approach (e.g., Stag Hunt Dilemma, Prisoner's Dilemma, War of the Sexes), designed to reflect family dynamics.
A mixed-methods approach will be employed to explore therapeutic changes across three key areas: (1) theory-of-mind brain networks, (2) narrative change, and (3) the overall well-being of family members reflected by the family functioning perceptions. Neurobiological data will be collected via functional Magnetic Resonance Imaging (fMRI) during an autobiographical, therapy-related task, conducted both before and after the intervention. This will be complemented by physiological measurements-including galvanic skin response (GSR), respiratory sinus arrhythmia (RSA), and heart rate variability (HRV)-to evaluate autonomic nervous system activity.
The investigators hypothesize that Narrative Family Therapy may promote neuroplasticity and restore effective connectivity within core brain circuits associated with social cognition, particularly the amygdala, ventromedial prefrontal cortex, and temporoparietal junction. Physiological data (GSR, HRV) collected during therapy sessions will also be analyzed to measure session-level effects. Specifically, the investigators will test whether autonomic arousal decreases across sessions and whether this reduction correlates with narrative development, assessed using the Assessment System of Narrative Change (ASNC) - a qualitative method based on empirical findings in Narrative Family Therapy.
To assess the feasibility and effectiveness of the therapeutic protocol, the Systemic Clinical Outcome and Routine Evaluation Scale (SCORE-15) and the Family Adaptability Cohesion Evaluation Scales IV Version (FACES-IV) will be administered. The investigators expect that the intervention will reduce mental health issues and enhance family functioning-such as communication, flexibility, and satisfaction-compared to the control group.
Overall, this study seeks to advance both scientific knowledge and clinical practice by fostering an innovative dialogue between Narrative Family Therapy and neuroscience.
This project aims to address that gap by characterizing families of individuals with autism, examining both individual and family-level variables, including their motivation to participate in Narrative Family Therapy. Participating families will be assigned to either an intervention group receiving Narrative Family Therapy or a control group engaged in a Game Theory-based approach (e.g., Stag Hunt Dilemma, Prisoner's Dilemma, War of the Sexes), designed to reflect family dynamics.
A mixed-methods approach will be employed to explore therapeutic changes across three key areas: (1) theory-of-mind brain networks, (2) narrative change, and (3) the overall well-being of family members reflected by the family functioning perceptions. Neurobiological data will be collected via functional Magnetic Resonance Imaging (fMRI) during an autobiographical, therapy-related task, conducted both before and after the intervention. This will be complemented by physiological measurements-including galvanic skin response (GSR), respiratory sinus arrhythmia (RSA), and heart rate variability (HRV)-to evaluate autonomic nervous system activity.
The investigators hypothesize that Narrative Family Therapy may promote neuroplasticity and restore effective connectivity within core brain circuits associated with social cognition, particularly the amygdala, ventromedial prefrontal cortex, and temporoparietal junction. Physiological data (GSR, HRV) collected during therapy sessions will also be analyzed to measure session-level effects. Specifically, the investigators will test whether autonomic arousal decreases across sessions and whether this reduction correlates with narrative development, assessed using the Assessment System of Narrative Change (ASNC) - a qualitative method based on empirical findings in Narrative Family Therapy.
To assess the feasibility and effectiveness of the therapeutic protocol, the Systemic Clinical Outcome and Routine Evaluation Scale (SCORE-15) and the Family Adaptability Cohesion Evaluation Scales IV Version (FACES-IV) will be administered. The investigators expect that the intervention will reduce mental health issues and enhance family functioning-such as communication, flexibility, and satisfaction-compared to the control group.
Overall, this study seeks to advance both scientific knowledge and clinical practice by fostering an innovative dialogue between Narrative Family Therapy and neuroscience.
Detailed Description:
None
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?:
None
Is an FDA AA801 Violation?: