Psychotherapy Group for Parents of Children With LCA

NCT07026565 | Not Yet Recruiting

• 1 other identifier: InstitutoGeneticO
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The objectives of this study are to evaluate the effect of a group psychotherapy intervention for parents of children/adolescents with LCA on indicators of emotional health, parental stress, acceptance, cognitive defusion, and mindfulness. The study design is a repeated measures design with pre-, post-, and 3-month follow-up assessments. Forty parents of children and adolescents with LCA will be included in the sample. Twenty will participate in the psychotherapy groups, divided into 2 groups of 10 people, and 20 will be in the control group. To assess the indicators mentioned in the objective, the following questionnaires will be applied: Self-Reporting Questionnaire, Parental Stress Scale, Acceptance and Action Questionnaire, Cognitive Fusion Questionnaire, and Freiburg Mindfulness Inventory. A subsequent data analysis will be conducted to evaluate and correlate these indicators before, after, and 3 months post-intervention.

Conditions

Leber Congenital Amaurosis (LCA)

Keywords

psychotherapeutic group; Leber congenital amaurosis; Acceptance and Commitment Therapy; Parental psychological well-being

Outcome Measures

Primary Outcomes (5)

• Self-Reporting Questionnaire

  The SRQ-20 questionnaire has been validated for the Brazilian population and contains 20 items that assess the presence or absence of mental disorders. The questions are scored in a dichotomous format, and a score of 7 or more indicates the possible presence of a mental disorder. The SRQ-20 serves as a screening tool but does not identify the specific mental disorder experienced by the patient.

  2 Months

• Freiburg Mindfulness Inventory

  The FMI assesses mindfulness through 14 items and has been validated for the Brazilian population. Each item is rated on a Likert scale from 1 to 4. Higher scores indicate that the individual acts more consistently with mindfulness.

  2 Months

• Cognitive Fusion Questionnaire

  The CFQ is a tool used to assess the degree of cognitive fusion, which refers to the tendency of individuals to identify with their thoughts and treat them as absolute truths. It consists of 7 items, is validated for use with the Brazilian population, and responses are rated on a scale from 1 to 7. Higher scores indicate a higher level of cognitive fusion.

  2 Months

• Acceptance and Action Questionnaire

  The AAQ-II questionnaire has been validated and adapted for Portuguese and contains 7 items that assess inflexible behaviors. The items are rated on a Likert scale from 1 to 7, where 1 means "Never" and 7 means "Always." Lower scores indicate greater psychological flexibility, meaning a higher ability to deal with different events in different ways.

  2 Months

• Parental Stress Scale

  The EEPa has been validated and adapted for Brazil and contains 16 items-eight questions related to parental satisfaction with the parenting experience and eight related to parental stressors. Responses are given on a Likert scale from 0 (strongly disagree) to 4 (strongly agree). The total score is 64 points, and higher scores indicate greater levels of parental stress experienced by participants.

  2 Months

Study Arms (2)

Intervention Group

EXPERIMENTAL

The psychotherapy group will consist of 10 virtual sessions, each lasting 1 hour and 15 minutes. Each session will begin with a mindfulness exercise to bring the participants into the present moment, followed by a pre-determined topic for discussion. At the end of each session, there will be a closing segment to summarize the reflections and teachings of the day, and a homework assignment will be provided. The topics covered will be: Opening, Psychoeducation, Diagnosis Report, Acceptance, Psychological Flexibility, Cognitive Defusion, Self as Context, Values, Committed Action, and Closure.

Behavioral: Psychotherapy group for parents

Control Group

ACTIVE COMPARATOR

For the parents who will participate in the control group, the steps undertaken will include the administration of the Self-Reporting Questionnaire, Parental Stress Scale, Acceptance and Action Questionnaire, Cognitive Fusion Questionnaire, and Freiburg Mindfulness Inventory, before the intervention, after the intervention, and after 3 months.

Behavioral: Control Group

Interventions

Psychotherapy group for parents BEHAVIORAL

The psychotherapy group will consist of 10 virtual sessions, each lasting 1 hour and 15 minutes. Each session will begin with a mindfulness exercise to bring the participants into the present moment, followed by a pre-determined topic for discussion. At the end of each session, there will be a closing segment to summarize the reflections and teachings of the day, and a homework assignment will be provided. The topics covered will be: Opening, Psychoeducation, Diagnosis Report, Acceptance, Psychological Flexibility, Cognitive Defusion, Self as Context, Values, Committed Action, and Closure.

Intervention Group

Control Group BEHAVIORAL

For the parents who will participate in the control group, the steps undertaken will include the administration of the Self-Reporting Questionnaire, Parental Stress Scale, Acceptance and Action Questionnaire, Cognitive Fusion Questionnaire, and Freiburg Mindfulness Inventory, before the intervention, after the intervention, and after 3 months.

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Forty parents of children and adolescents with LCA will be included in the sample. These parents must have both the clinical and genetic diagnoses of their children.

Sponsors & Collaborators

• Instituto de Genética Ocular: lead

Study Sites (1)

Instituto de Genética Ocular

São Paulo, 04552-050, Brazil

Location

MeSH Terms

Conditions

Leber Congenital Amaurosis

Interventions

Psychotherapy, Group; Control Groups

Condition Hierarchy (Ancestors)

Eye Diseases, Hereditary; Eye Diseases; Retinal Diseases

Intervention Hierarchy (Ancestors)

Socioenvironmental Therapy; Psychotherapy; Behavioral Disciplines and Activities; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Cecília F Vasconcellos, PhD studant

  Ocular Genetic Institute

  PRINCIPAL INVESTIGATOR

• JULIANA F SALLUM, Post-doc

  Ocular Genetic Institute

  STUDY CHAIR

• Caio Marques, PhD studant

  Ocular Genetic Institute

  STUDY DIRECTOR

Central Study Contacts

Cecília F Vasconcellos, PhD

CONTACT

5511983114036; psicoceciliavasconcellos@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2025
• First Posted: June 18, 2025
• Study Start: August 1, 2025
• Primary Completion: February 27, 2026
• Study Completion (Estimated): May 30, 2026
• Last Updated: June 18, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)