NCT07246395

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
63

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 8, 2023

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

September 11, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 24, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

November 24, 2025

Status Verified

November 1, 2025

Enrollment Period

2.9 years

First QC Date

September 11, 2025

Last Update Submit

November 17, 2025

Conditions

Keywords

Autism Spectrum DisorderNarrative Family TherapyFamily FunctioningTherapeutic Change

Outcome Measures

Primary Outcomes (1)

  • Change from baseline to the post-intervention in the Systemic Clinical Outcome Routine Evaluation - 15 items (SCORE-15)

    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

    From baseline to the end of treatment at 5 months, and to follow-up to 8 months (from baseline).

  • Assessment System of Narrative Change

    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)

    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)

    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.

    From pre-baseline (before the enrolment on the intervention study) to follow up within a month after the follow-up.

  • +4 more secondary outcomes

Study Arms (2)

Control Arm

ACTIVE COMPARATOR

The control group will receive a family-based intervention grounded in Game Theory.

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.

Behavioral: Narrative Family Therapy

Interventions

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.

Experimental Arm

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.

Control Arm

Eligibility Criteria

Age8 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Participants with brain injury, alcoholism, drug abuse, active psychosis, homicidal/suicidal ideation, and personality disorder.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute for Nuclear Sciences Applied to Health (ICNAS), University of Coimbra

Coimbra, Portugal

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full Professor

Study Record Dates

First Submitted

September 11, 2025

First Posted

November 24, 2025

Study Start

February 8, 2023

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

November 24, 2025

Record last verified: 2025-11

Locations