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Completed

NCT Number: NCT05268315

A Brief Parental Intervention on Learning and Education in Childhood Cancer

The purpose of this study is to assess whether a brief intervention about learning and education is both practical and acceptable for parents of children with cancer.

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Key information

Conditions

Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of New Mexico Hospital

Albuquerque, New Mexico, 87106, United States

About this study

After being provided details about the study, participants signing the study consent form complete pre-intervention questionnaires. Participants then complete a brief psychoeducational intervention, via a HIPAA-compliant web and video conferencing platform on Zoom. The intervention is followed by completion of a post-intervention evaluation form. The consent form and study questionnaires are completed through Research Electronic Data Capture (REDCap), a secure web-based application.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • parent(s) or legal guardian(s) of children with cancer
  • preferred language for oral and written communication is English
  • 18 years of age or older
  • 1 or 2 parents or legal guardians can participate for each child

The child must also meet the following for the parent(s)/legal guardian(s) to participate:

  • diagnosis of cancer
  • child is actively receiving cancer treatment at University of New Mexico Hospital or recently completed treatment (within 0-6 months post-treatment)
  • child is between the age of 3 and 14
  • child resides in New Mexico

Exclusion criteria

Parents of children who are wards of the state are excluded (including children in custody of the NM Children, Youth & Families Department).

Treatment and study plan

Brief Psychoeducational Intervention

Behavioral

The 1-session psychoeducational intervention is divided into three brief modules. Topics that are covered include thinking, learning, emotional, and behavioral functioning as they relate to childhood cancer, educational and school supports, and the role of neuropsychological and school-based assessments.

Primary outcomes

  1. Feasibility of study recruitment and enrollment

    Time frame: Through study completion, up to 2 years

    Among qualifying families, the number receiving recruitment information about the study, identifying interest, scheduling, and completing procedures. Note, for each qualifying family, one or two parents or legal guardians are able to enroll in the study. This is a parental intervention and the child with cancer does not participate in the study.

  2. Fidelity to the intervention protocol

    Time frame: at time of intervention (day 1)

    Interventions are audio-recorded. Percent adherence to the intervention protocol per a fidelity form, developed for this study, is assessed by an independent rater of fidelity.

  3. Acceptability of the intervention

    Time frame: immediately post-intervention (day 1)

    Ratings are provided on intervention acceptability as part of the Program Evaluation Form, a questionnaire developed for this study.

Sponsors and collaborators

Lead sponsor

University of New Mexico

Other

Collaborators

  • Hyundai Hope On Wheels

Registry information

Official study title

Acceptability and Feasibility of a Brief Psychoeducational Intervention for Parents of Children With Childhood Cancer

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 7, 2022
Registry last updated
Jul 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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