- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07246395
NarraTivAS - Narrative Family Therapy in Autism Spectrum (NarraTivAS)
Narrative Family Therapy in Autism Spectrum: From Clinical Neuroscience to Intervention Outcomes
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Coimbra, Portugal
- Institute for Nuclear Sciences Applied to Health (ICNAS), University of Coimbra
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Families of children, adolescents and/or young adults with ages ranging from 8 to 18 years;
- Children, adolescents and/or young adults with a primary diagnosis of Autism Spectrum Disorder, verbally fluent, and without intellectual impairment (intelligence quotient above 70 as measured by the Wechsler Intelligence Scale for Children or Adults - 3rd Edition, WISC-III or WAIS-III).
- Nuclear intact, divorced, large, and single-parent families.
Exclusion Criteria:
- Participants with brain injury, alcoholism, drug abuse, active psychosis, homicidal/suicidal ideation, and personality disorder.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: Control Arm
The control group will receive a family-based intervention grounded in Game Theory.
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The control group will receive a Family Game Theory-based approach consisting of eight sessions, each lasting 60-90 minutes and conducted without a therapist.
The first four sessions are held weekly, while the remaining sessions occur monthly, followed by a final follow-up three months after the last session.
This approach was designed to reflect family dynamics through three classical game theory models: the Stag Hunt, the Prisoner´s Dilemma, and the Battle of the Sexes.
Each session begins with a phase in which family members are invited to share something with one another.
Then, they participate in a round of non-verbal dyadic games using a tablet.
Finally, they are encouraged to reflect and share what they took from the session.
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Experimental: Experimental Arm
The experimental group will receive Narrative Family Therapy for Autism Spectrum Disorder, a brief manualized intervention.
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Participants in the intervention group will attend eight Narrative Family Therapy sessions, each lasting 60-90 minutes with one therapist.
The first four sessions occur weekly; the remaining are monthly, with a follow-up three months after the final session.
This brief, manualized therapy was developed to address the specific needs of families with autistic members.
It uses sensory materials and preferred topics as entry points for therapeutic dialogue.
Each session begins with the autistic individual and concludes by asking each participant to share what they took from the session.
Information is presented visually (e.g., brain style profile) to match the visual strengths of individuals with autism.
The intervention aims to promote narrative transformation, leading to changes in stories, relationships, and perspectives.
These shifts help participants express and organize their experiences more adaptively, supporting improved interpersonal relationships and functioning.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Change from baseline to the post-intervention in the Systemic Clinical Outcome Routine Evaluation - 15 items (SCORE-15)
Time Frame: From baseline to the end of treatment at 5 months.
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From baseline to the end of treatment at 5 months.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change from baseline to the post-intervention (5 months) and follow up (8 months later) in the Portuguese Family Communication and Family Cohesion - Version IV
Time Frame: From baseline to the end of treatment at 5 months, and to follow-up to 8 months (from baseline).
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From baseline to the end of treatment at 5 months, and to follow-up to 8 months (from baseline).
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Assessment System of Narrative Change
Time Frame: At each intervention session from first to last (intervention last 5 months) and at follow-up (after 3 months from the last intervention session).
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A coding system will assess the narrative change - the Assessment System of Narrative Change (Sequeira & Alarcão, 2013).
This system was developed to assess and classify narratives expressed in therapy to trace changes over the course of therapy (Sequeira & Alarcão, 2013).
The coding measure that will be used will cover areas of narrative change such as: Total number of specific codes in each session (please cf.
Sequeira & Alarcão, 2013).
The measure will be used to code transcripts on a session-by-session basis and is therefore a process measure.
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At each intervention session from first to last (intervention last 5 months) and at follow-up (after 3 months from the last intervention session).
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BOLD changes from baseline to the post intervention (5 months)
Time Frame: Assessments will be conducted within two weeks prior to the first intervention session and within two weeks following the end of the intervention (at five months).
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BOLD signal changes from baseline to the post intervention (5 months), during an Functional Magnetic Imaging Ressonance (fMRI) task of visualization of autobiographical images
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Assessments will be conducted within two weeks prior to the first intervention session and within two weeks following the end of the intervention (at five months).
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The Satisfaction with Therapy and Therapist Scale-Revised adaptation after the follow-up (8 months)
Time Frame: After the follow-up session (8 months from baseline) within a month.
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After the follow-up session (8 months from baseline) within a month.
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The long-term effect from pre-baseline (before intervention study enrollment) to the follow-up session on the Social Responsivness Scale- 16 items scores.
Time Frame: From pre-baseline (before the enrolment on the intervention study) to follow up within a month after the follow-up.
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From pre-baseline (before the enrolment on the intervention study) to follow up within a month after the follow-up.
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The long-term effect from pre-baseline (before intervention study enrollment) to the follow-up session on Brief Measure of Parental Wellbeing
Time Frame: From pre-baseline (before the enrolment on the intervention study) to follow up within a month after the follow-up.
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From pre-baseline (before the enrolment on the intervention study) to follow up within a month after the follow-up.
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The long-term effect from pre-baseline (before intervention study enrollment) to the follow-up session on Walsh Family Resilience Questionnaire
Time Frame: From pre-baseline (before the enrolment on the intervention study) to follow up within a month after the follow-up.
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From pre-baseline (before the enrolment on the intervention study) to follow up within a month after the follow-up.
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The long-term effect from pre-baseline (before intervention study enrollment) to the follow-up session on Coparenting Questionnaire
Time Frame: From pre-baseline (before the enrolment on the intervention study) to follow up within a month after the follow-up.
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From pre-baseline (before the enrolment on the intervention study) to follow up within a month after the follow-up.
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Skin Conductance Response
Time Frame: At each intervention session from first to last (intervention last 5 months) and at follow-up (after 3 months from the last intervention session
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At each intervention session from first to last (intervention last 5 months) and at follow-up (after 3 months from the last intervention session
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NarraTivASD01CIBIT
- 2021.05559.BD (Other Grant/Funding Number: Fundação para a Ciência e Tecnologia (FCT))
- UID/4950/2025 (Other Grant/Funding Number: Fundação para a Ciência e Tecnologia (FCT))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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