NCT06681103

Brief Summary

The goal of this study is to investigate if personalized online normative feedback (PONF) can increase intention to change and help-seeking behaviors in young adults with gambling or trading problems in Spain. The main questions it aims to answer are:

  • Evaluation group: A control group with pre- and post-assessments.
  • Delayed evaluation group: A control group with only a post-assessment, to control for the effect of the assessment.
  • FNPO group: An intervention group receiving PONF after the initial evaluation and completing both pre- and post-assessments. Participants will:
  • Receive PONF or no feedback at the first evaluation.
  • Complete initial and follow-up assessments after 12 weeks.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,112

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

November 7, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 8, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

December 20, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

January 30, 2026

Status Verified

January 1, 2026

Enrollment Period

6 months

First QC Date

November 7, 2024

Last Update Submit

January 28, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Intention to change

    The study will assess intention to change and help-seeking behavior using three custom items. In the initial assessment, participants will respond to a dichotomous question regarding whether they have considered reducing or abandoning gambling/trading in the past year. They will also rate the likelihood of engaging in these behaviors over the next 12 months on a scale from 0% (not likely) to 100% (very likely). Finally, participants will indicate their goal regarding their gambling/trading behavior, choosing from options to reduce, increase, maintain, or cease the behavior.

    Baseline, immediate follow-up (after PONF), 3-month follow-up

  • Treatment-seeking behavior

    Treatment-seeking behavior will be assessed during the initial evaluation using a the following question: "Have you ever sought professional help, advice from family or friends, or done something on your own to limit or reduce your \[gambling/trading\] behavior?" If participants answer "yes," they will complete the Help-Seeking Questionnaire (HSQ), which includes 14 items assessing in-person (e.g., seeing a psychologist), remote (e.g., calling a helpline), and self-directed (e.g., reading forums or searching websites) help-seeking behaviors.

    Baseline, immediate follow-up (after PONF), 3-month follow-up

Secondary Outcomes (3)

  • Gambling and trading behaviors

    Baseline, immediate follow-up (after PONF), 3-month follow-up

  • Disordered gambling

    Baseline, 3-month follow-up

  • Disordered trading

    Baseline, 3-month follow-up

Other Outcomes (4)

  • Gambling and trading-related harms

    Baseline and 3-month follow-up

  • Gambling and trading self-efficacy

    Baseline and 3-month follow-up

  • Peer gambling and trading

    Baseline

  • +1 more other outcomes

Study Arms (3)

Personalized Online Normative Feedback (PONF)

EXPERIMENTAL

Participants in this group complete a pre-assessment measuring intention to change, help-seeking behavior, and gambling and trading behaviors (e.g., frequency and spending). They then receive personalized online normative feedback (PONF) based on their initial assessment and subsequently complete a post-assessment including the same outcomes. Within this intervention arm, participants are randomly assigned to one of two predefined assessment sequences (PNF-A vs. PNF-B), differing only in the timing of the post-intervention assessment of gambling and trading behaviors. This sequencing is implemented exclusively to support secondary analyses of potential reporting reactivity (e.g., social desirability) and does not involve any differences in intervention content, delivery, or assessment of the primary motivational outcomes.

Behavioral: Personalized Normative Feedback

Control group 1 (Assessment group)

NO INTERVENTION

Participants in this group will complete both pre- and post-assessments on intention to change, help-seeking behavior, and gambling/trading behaviors. However, they will not receive any feedback. This group serves as a comparison to both intervention groups.

Control group 2 (Delayed Assessment Group)

NO INTERVENTION

This group will complete only the post-assessment, measuring intention to change, help-seeking behavior, and gambling/trading behaviors, without completing a pre-test or receiving feedback, to independently analyze the immediate effects of the pre-test.

Interventions

Those participating in this condition will receive a personalised brief report which summarises the results of their initial assessment. The PONF will comprise the following elements: (1) Details of the main gambling and trading activities performed, including frequency of engagement and amount of money spent; (2) Scores on the criteria of pathological trading and/or PGSI (problem gambling), together with an interpretation of the results and the level of severity. All results will be accompanied by graphs enabling participants to compare their scores with the average scores of the Spanish population of the same sex and age range. To prevent an increase in behaviour in participants whose frequency or intensity of gambling/trading is below the norm, as recommended by Newall et al. (2023), the normative data will include extreme averages and percentages. All participants assigned to the PNF intervention receive identical feedback content, regardless of assessment sequencing.

Personalized Online Normative Feedback (PONF)

Eligibility Criteria

Age18 Years - 34 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may not qualify if:

  • Engaged in trading or gambling activities (land-based or online) at least once per month in the past 60 days
  • Aged 18-34 years
  • Residing in Spain
  • Provide informed consent to participate in initial online assessment, post-test, and follow-up
  • Currently undergoing psychological or psychiatric treatment
  • Scoring above 3 on the Oviedo Infrequency Scale (Fonseca-Pedrero et al., 2009), indicating potential random/pseudorandom or dishonest responses.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Miguel Hernández University

Elche, Alicante, 03202, Spain

Location

MeSH Terms

Conditions

Gambling

Condition Hierarchy (Ancestors)

Risk-TakingBehaviorDisruptive, Impulse Control, and Conduct DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: This design follows a Solomon three-group structure, enabling the independent evaluation of the immediate effects that the pre-test assessment and the intervention may have on the study's dependent variables (intention to change and help-seeking behavior), as well as their maintenance three months after the intervention. The following experimental conditions will be established: (1) control group with pre- and post-test assessment (assessment group), (2) control group with post-test assessment only (delayed assessment group) and (3) intervention group with pre- and post-test assessment, which will also receive personalised online normative feedback on their gambling and trading behaviour after the initial assessment (PONF group). To adapt the PONF to each participant it is necessary to conduct a pre-test assessment, so an adaptation of Solomon's design will be used.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

November 7, 2024

First Posted

November 8, 2024

Study Start

December 20, 2024

Primary Completion

June 30, 2025

Study Completion

June 30, 2025

Last Updated

January 30, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations