Autism Spectrum DisorderNarraTivASNCT07246395
NarraTivAS - Narrative Family Therapy in Autism Spectrum
A study testing Narrative Family Therapy and Family Game Theory-based Intervention in people with Autism Spectrum Disorder, run by University of Coimbra at 1 site in Portugal.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Narrative Family Therapy and Family Game Theory-based Intervention
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 sitePortugal
- Study dates
- 8 Feb 2023to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- Participants with brain injury, alcoholism, drug abuse, active psychosis, homicidal/suicidal ideation, and personality disorder.
Trial locations and contacts
1 site in 1 country.
Portugal1 site
Institute for Nuclear Sciences Applied to Health (ICNAS), University of Coimbra
Coimbra
About this study
Official title: 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.
Read more
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.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Narrative Family Therapy, Family Game Theory-based Intervention
- Keywords
- Autism Spectrum Disorder, Narrative Family Therapy, Family Functioning, Therapeutic Change
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Narrative Family TherapyBehavioural
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.
Family Game Theory-based InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Arm | Active comparator | The control group will receive a family-based intervention grounded in Game Theory. Receives: Behavioral: Family Game Theory-based Intervention |
| Experimental Arm | Experimental | The experimental group will receive Narrative Family Therapy for Autism Spectrum Disorder, a brief manualized intervention. Receives: Behavioral: Narrative Family Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to the post-intervention in the Systemic Clinical Outcome Routine Evaluation - 15 items (SCORE-15)
Measured: From baseline to the end of treatment at 5 months.
Secondary outcomes (9)
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
Measured: From baseline to the end of treatment at 5 months, and to follow-up to 8 months (from baseline).
Assessment System of Narrative Change
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.
Measured: At each intervention session from first to last (intervention last 5 months) and at follow-up (after 3 months from the last intervention session).
BOLD changes from baseline to the post intervention (5 months)
BOLD signal changes from baseline to the post intervention (5 months), during an Functional Magnetic Imaging Ressonance (fMRI) task of visualization of autobiographical images
Measured: 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).
The Satisfaction with Therapy and Therapist Scale-Revised adaptation after the follow-up (8 months)
Measured: After the follow-up session (8 months from baseline) within a month.
The long-term effect from pre-baseline (before intervention study enrollment) to the follow-up session on the Social Responsivness Scale- 16 items scores.
Measured: From pre-baseline (before the enrolment on the intervention study) to follow up within a month after the follow-up.
The long-term effect from pre-baseline (before intervention study enrollment) to the follow-up session on Brief Measure of Parental Wellbeing
Measured: From pre-baseline (before the enrolment on the intervention study) to follow up within a month after the follow-up.
The long-term effect from pre-baseline (before intervention study enrollment) to the follow-up session on Walsh Family Resilience Questionnaire
Measured: From pre-baseline (before the enrolment on the intervention study) to follow up within a month after the follow-up.
The long-term effect from pre-baseline (before intervention study enrollment) to the follow-up session on Coparenting Questionnaire
Measured: From pre-baseline (before the enrolment on the intervention study) to follow up within a month after the follow-up.
Skin Conductance Response
Measured: At each intervention session from first to last (intervention last 5 months) and at follow-up (after 3 months from the last intervention session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start8 Feb 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Coimbra
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Miguel Castelo-Branco, University of Coimbra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07246395
- Sponsor's protocol ID
- NarraTivASD01CIBIT
- Other IDs
- 2021.05559.BD, UID/4950/2025
- Acronym
- NarraTivAS
- Status last verified
- Nov 2025
- First submitted
- 11 Sep 2025
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Narrative Family Therapy in Autism Spectrum: From Clinical Neuroscience to Intervention Outcomes
- ClinicalTrials.gov ID
- NCT07246395
- Acronym / sponsor ID
- NarraTivAS / NarraTivASD01CIBIT
- Conditions
- Autism Spectrum Disorder
- Keywords
- Autism Spectrum Disorder, Narrative Family Therapy, Family Functioning, Therapeutic Change
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 63 participants (actual)
- Lead sponsor
- University of CoimbraUniversity, hospital or other
- Study start
- 8 Feb 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 24 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Arm | Active comparator | Behavioral: Family Game Theory-based InterventionThe control group will receive a family-based intervention grounded in Game Theory. |
| Experimental Arm | Experimental | Behavioral: Narrative Family TherapyThe experimental group will receive Narrative Family Therapy for Autism Spectrum Disorder, a brief manualized intervention. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Participants with brain injury, alcoholism, drug abuse, active psychosis, homicidal/suicidal ideation, and personality disorder.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Narrative Family TherapyParticipants 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. | Behavioural | Experimental Arm |
| Family Game Theory-based InterventionThe 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. | Behavioural | Control Arm |
Primary outcome
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.
9 secondary outcomes
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).
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).
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).
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.
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.
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.
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.
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.
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Narrative Family Therapy and Family Game Theory-based Intervention in people with Autism Spectrum Disorder, run by University of Coimbra at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2025.