- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04531761
Evaluating the Efficacy of the Parent Support Program (PSP)
February 3, 2023 updated by: Em Matsuno, Palo Alto University
The objective of the study is to evaluate the efficacy of an online intervention (the Parents Support Program) aimed at increasing supportive behaviors among parents of transgender youth.
The intervention consists of three modules that include a variety engaging activities such as social perspective taking exercises, writing prompts, videos of parents, youth, and experts, and psycho-educational materials.
The study uses an experimental design with a waitlist control.
Both the experimental and control groups will complete a pre-test, one month follow up, and two month follow up survey.
Targeted outcomes include knowledge about gender diversity, attitudes about trans youth, and supportive parenting behaviors.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
570
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Palo Alto, California, United States, 94304
- Palo Alto University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Must be 18 years of age or older.
- Must live in the United States.
- Must be comfortable communicating in English.
- Must be a parent of a trans child between the ages of 10 - 24.
Exclusion Criteria:
- Participants who participated in pilot study or focus groups related to this project.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Immediate Access to Parent Support Program
|
The parent support program includes three modules aimed at increasing knowledge, positive attitudes, and supportive behaviors towards trans youth.
Each online module includes several activities including writing prompts, videos, interactive quizzes, and other educational activities.
|
|
NO_INTERVENTION: Waitlist Control
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Trans-supportive behaviors scale
Time Frame: One month
|
This 20 item questionnaire measures the frequency of supportive behaviors enacted in the past month.
Response options ranged from 1 (never) to 5 (frequently) based on item anchors from the Ryan et al. (2010) measure on family acceptance.
The original 25-item scale was reduced to 20 items based on achieving adequate internal consistency reliability in a previous study with parents of trans youth (Matsuno & Israel, in preparation).
An example item is: "I told my child I respect and support them."
The measure showed adequate internal consistency reliability in the pilot study of the Parent Support Program (α = .8).
|
One month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Attitudes Toward Trans Youth Scale (ATTYS - Birnkrant, 2018)
Time Frame: One month
|
Two subscales of the original scale were used consisting of 27 items- Genderism, and Fabricated Identity.
The scale had strong reliablity α = .98
and demonstrated convergent and discriminant validity.
|
One month
|
|
Objective knowledge about gender diversity
Time Frame: One month
|
The author created a 18-item measure designed to test knowledge about constructs of gender and experiences of transgender people.
The items are based on the program content and through best practices for creating multiple choice questions.
|
One month
|
|
Subjective knowledge about gender diversity
Time Frame: One month
|
Participants perceptions of their own level knowledge regarding gender diversity will be measured using a 100-point Likert scale from 1 - not at all knowledgeable to 100- extremely knowledgeable.
Participants will be asked to rate their perceived knowledge in the following areas: gender terminology, etiology, medical intervention, and impact of parental acceptance.
|
One month
|
|
Self-compassion
Time Frame: One month
|
Self-compassion was measured by adapting the self-kindness subscale of the Self-Compassion Scale - Short Form (SCS-SF) (Raes, Pommier, Neff, & Van Gucht, 2011).
The subscale demonstrated adequate reliability in a previous sample (α = .78)
(Raes et al., 2011).
The five items were adapted by adding "as a parent of a trans/non-binary child" at the end of each item to measure self-compassion related to parenting a trans child.
Items were rated on a 5-point Likert scale ranging from 1 (almost never) to 5 (almost always).
The measure showed strong internal consistency reliability in the pilot study of the Parent Support Program (α = .94).
|
One month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Em Matsuno, PhD, Palo Alto University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
September 27, 2020
Primary Completion (ACTUAL)
December 1, 2021
Study Completion (ACTUAL)
December 1, 2021
Study Registration Dates
First Submitted
August 17, 2020
First Submitted That Met QC Criteria
August 25, 2020
First Posted (ACTUAL)
August 28, 2020
Study Record Updates
Last Update Posted (ACTUAL)
February 8, 2023
Last Update Submitted That Met QC Criteria
February 3, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- 2019-116
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
No IPD will be shared with other researchers.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Knowledge, Attitudes, Practice
-
Pamela HughesActive, not recruitingKnowledge, Attitudes, PracticeUnited States
-
Hacettepe UniversityCompletedKnowledge, Attitudes, PracticeTurkey
-
Ahmad Nassar IbrahimAssiut UniversityUnknownKnowledge, Attitudes, Practice
-
Medical University of LodzCompletedKnowledge, Attitudes, PracticePoland
-
Maharishi Markendeswar University (Deemed to be...CompletedKnowledge, Attitudes, Practice
-
University of ChicagoCompletedKnowledge, Attitudes, PracticeUnited States
-
University of GuelphCompletedKnowledge, Attitudes, PracticeCanada
-
Queen's University, BelfastInvest NICompletedKnowledge, Attitudes, PracticeUnited Kingdom
-
Rana Abd El-Sattar Omar RamadanUnknownKnowledge, Attitudes, Practice
-
Universiti Teknologi MaraRecruitingKnowledge, Attitudes, PracticeMalaysia
Clinical Trials on Parent Support Program
-
Karolinska InstitutetDalarna UniversityCompleted
-
McGill University Health Centre/Research Institute...Canadian Institutes of Health Research (CIHR); University of AlbertaCompletedParent-Child Relations | Autism Spectrum Disorder | Parenting | Mental Health Wellness 1 | Parent-child Problem | Child Development Disorder | Child Developmental DelayCanada
-
University of MiamiNational Heart, Lung, and Blood Institute (NHLBI)CompletedAnemia, Sickle Cell | Hemoglobin SC DiseaseUnited States
-
University of GlasgowUniversity of Nottingham; Queen Mary University of London; National Society for... and other collaboratorsActive, not recruitingParent-Child Relations | Child Mental Disorder | Child MaltreatmentUnited Kingdom
-
Florida International UniversityBuffalo Prenatal Perinatal NetworkCompletedParenting | Child MaltreatmentUnited States
-
Erin Hayes Kelly, PhDThe Craig H. Neilsen FoundationCompletedSpinal Cord InjuriesUnited States
-
University of ManitobaUnknown
-
Memorial Sloan Kettering Cancer CenterRecruitingObesity | Weight Loss | Child ObesityUnited States
-
Johns Hopkins UniversityNational Institute of Nursing Research (NINR); University of Iowa; Hugo W. Moser...Completed
-
National Cheng Kung UniversityCompletedAutism Spectrum Disorder