Psychometric Validation of the Psychosocial Assessment Tool in Caregivers of Pediatric Cancer Patients.

NCT07321392 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 236

Last updated 2026-03-31

No results posted yet for this study

Summary

The reported mental health, economic and structural problems of pediatric cancer patients end up negatively affecting family functioning and the course of the disease; therefore, in the Mexican context it is necessary to have a valid, reliable and culturally relevant tool to identify psychosocial risks in children and adolescents with cancer. in order to develop strategies to address psychosocial needs. Objective: To determine the psychometric validation of the Mexican version of the Psychosocial Assessment Tool (PAT) for informal primary caregivers of pediatric cancer patients. Method: A study will be carried out with a prospective multicenter instrumental design of correlational scope and a non-probabilistic sampling will be used at the convenience of informal primary caregivers of pediatric cancer patients. The indices of relevance, writing and adequate language will be evaluated, in order to obtain content validity of each of the 68 items, using the Aiken V, reliability will be evaluated by calculating the Kuder-Richardson 20 coefficient to determine internal consistency and structural or construct validity will be evaluated by means of an exploratory factor analysis. Results: According to the guidelines for adaptation and validation of psychological instruments, the inventory will be translated into the original language (English - Spanish), the inventory will be backtranslated into the original language (Spanish - English), the evidence of content validity will be obtained by expert judges, and the evidence of construct validity and reliability indices of the inventory will be piloted and obtained with the white sample.

Keywords: Pediatric patients, cancer, psychosocial risk, informal primary caregivers, pediatric oncology.

Conditions

  • Pediatric Patients With Cancer
  • Informal Primary Caregivers

Interventions

DIAGNOSTIC_TEST

Psychosocial Assessment Tool (PAT)

The PAT is a brief report for informal primary caregivers that assesses family psychosocial risk based on a families' ecological social model. This model assesses psychosocial risks throughout the child's social environment and generates seven subscale scores, such as Family Structure/Resources, Social Support, Children's Problems, Sibling Problems, Family Problems, Stress Reactions, and Family Beliefs. The total score, which ranges from 0 to 7, is assigned to the PPPHM with three risk levels: universal (\<1.00), specific (1.00 and 2.00) and clinical (\>2.00). To translate the PAT into Spanish, methods that met or exceeded the guidelines of Holmbeck and Devine were used. First, the PAT was independently translated and back-translated by two native Spanish-speaking psychologists \[62\]. Then, an independent native Spanish speaker reviewed it and consulted with a certified translator.

Sponsors & Collaborators

  • Aquí Nadie Se Rinde I.A.P.

    lead OTHER

Principal Investigators

  • Alejandro Hernández-Posadas, M.A. · Aquí Nadie Se Rinde I.A.P.

  • Laura Estefanía Montejo-Salas, M.A. · Aquí Nadie Se Rinde I.A.P.

  • Norma Ayde González-Cisneros, B.A. · Aquí Nadie Se Rinde I.A.P.

  • Fátima Sagrario Espinosa-Salgado, PhD. · Instituto Nacional de Pediatría

  • Alberto Olaya-Vargas, PhD. · Instituto Nacional de Pediatría

  • Rocío del Socorro Cárdenas-Cardos, PhD. · Instituto Nacional de Pediatría

  • Liliana Velasco-Hidalgo, PhD. · Instituto Nacional de Pediatría

  • José Felix Gaytán-Morales, PhD. · Hospital Infantil de Mexico Federico Gomez

  • Shaila Rubí García-Zapotitla, Psic. · Aquí Nadie Se Rinde I.A.P.

  • José Edén Martínez-Bojórquez, Psic. · Aquí Nadie Se Rinde I.A.P.

  • Jonathan David Abrego-Rojas, B.A. · Aquí Nadie Se Rinde I.A.P.

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-10
Primary Completion
2026-03-31
Completion
2026-03-31

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07321392 on ClinicalTrials.gov