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Develop and Validation of Measurement-Based Transition Assistance

Measurement-Based Transition Assistance (MBTA): Evaluating the Promise of a Web-Based Approach to Promote Veterans' Support Seeking

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05384171
Acronym
MBTA
Enrollment
46
Registered
2022-05-20
Start date
2022-11-03
Completion date
2023-06-26
Last updated
2024-10-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Well-being

Keywords

well-being, mental health, help-seeking, veteran

Brief summary

Although some Veterans seek help when they experience post-military readjustment challenges, many do not. One factor that stands in the way of Veterans' willingness to seek help for these challenges is their lack of knowledge, both with regard to how severe challenges must be to warrant help-seeking and what resources are available to address these challenges. Measurement-Based Transition Assistance (MBTA) aims to address these barriers to help-seeking by providing Veterans with individualized feedback on areas in which they would benefit from additional support with regard to their health, vocational, financial, and social circumstances, along with personalized recommendations for relevant programs, services, and supports. If effective, this scalable, population-based intervention strategy could be used independently or in conjunction with other approaches to enhancing Veterans' help-seeking to interrupt high-risk trajectories before they lead to chronic maladjustment and increased risk for suicide.

Detailed description

Background: There is a growing recognition that Veterans' broader vocational, financial, and social circumstances have substantial implications for their health and health care. These circumstances include factors such as whether a Veteran has a job, can pay his or her bills, and has a strong social support network. Although some Veterans seek help when they experience challenges in these life domains, many do not. One factor that stands in the way of Veterans' help-seeking is lack of knowledge, both with regard to how severe challenges must be to warrant help-seeking and what resources are available to address these challenges. If not addressed, Veterans' readjustment challenges may become chronic, escalate in severity, and negatively influence more aspects of Veterans' lives over time and thus, become more difficult to intervene on. Significance: This study will provide a preliminary examination of the potential benefit of Measurement-Based Transition Assistance (MBTA) in promoting Veterans' help-seeking. MBTA involves providing individualized feedback on areas in which Veterans would benefit from additional support, along with personalized recommendations for relevant programs, services, and supports. If effective, this scalable, population-based intervention strategy could be used independently or in conjunction with other help-seeking promotion approaches to interrupt high-risk trajectories before they lead to chronic maladjustment and risk for suicide. Innovation and Impact: While there has been substantial attention to the importance of promoting Veterans' use of mental health care, the investigators are not aware of any broad, measurement-based effort to enhance Veterans' willingness to seek help for multiple areas of unmet need. In addition, most intervention strategies are targeted to the needs of Veterans with chronic patterns of functional impairment and poor health rather than Veterans who experience initial readjustment challenges as they adapt to post-military life. The current project is innovative in its evaluation of a self-administered, population-based approach to raise Veterans' awareness of areas in which they may benefit from additional support and to connect them with relevant resources. Given that MBTA may be most beneficial to Veterans who experience initial readjustment challenges as they adapt to post-military life, this intervention will be evaluated among Veterans who have recently left military service. Specific Aim: Aim 1 is to refine MBTA based on input from VA stakeholders (n=6) and qualitative interviews with Veterans (n=12). A key focus of this aim is to determine the optimal approach for presenting results and recommended resources. Aim 2 is to evaluate the feasibility, acceptability, and preliminary effectiveness of MBTA in promoting Veterans' support-seeking by testing this intervention in a sample of 60 Veterans. Methodology: The proposed work will be guided by established methods for intervention development and implementation that emphasize user-centered design principles and iterative cycles of refinement and pilot testing to enhance MBTA's effectiveness and scalability. After refining MBTA based on feedback from VA stakeholders and Veterans (Aim 1), a national sample of Veterans will be randomized to MBTA or an assessment-only condition in a pilot randomized controlled trial (RCT) (Aim 2). The MBTA assessment will be comprised of validated measures of Veterans' status, functioning, and satisfaction across life domains, along with well-established mental health screeners. Veterans in the MBTA condition will receive a user-friendly web-based report that summarizes areas of unmet need, as well as tailored recommendations for relevant resources. Feasibility and acceptability will be evaluated based on participation and completion rates, as well as satisfaction and usability ratings. The investigators will also examine preliminary evidence for effectiveness by comparing pre-post changes in support-seeking outcomes for Veterans in intervention and control conditions. Only quantitative results from this pilot study are presented in clinicaltrials.gov. Next Steps/Implementation: This pilot study will inform a subsequent proposal for a fully powered RCT to confirm the effectiveness of MBTA and to evaluate strategies to promote its dissemination and implementation.

Interventions

BEHAVIORALMeasurement-Based Transition Assistance (MBTA)

Measurement-Based Transition Assistance (MBTA) asks Veterans about their well-being and then provides Veterans with individualized feedback on areas in which they would benefit from additional support with regard to their health, vocational, financial, and social circumstances, along with personalized recommendations for relevant programs, services, and supports.

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

Participants are randomized to an assessment only condition or to the full MBTA intervention (assessment, feedback and resource recommendations)

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* having separated from active duty military service within the prior three years, but not the past three months (for whom not enough time may have gone by to adequately assess readjustment challenge) * having a postal address in the U.S * having access to the internet

Exclusion criteria

None

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants Assessed for the Feasibility of Study Proceduresbaseline (T1) and three-month follow-up (T2)Participation in the study will be evaluated to assess feasibility of the study procedures. To determine feasibility, at the end of data collection the investigators will calculate the following: 1. Percentage of veterans who enroll in the study out of those invited (baseline; T1) 2. Percentage of veterans who complete both T1 and T2 surveys (baseline \[T1\] and three-month follow-up \[T2\] data) 3. Percentage of veterans who access the MBTA assessment (baseline \[T1\] for intervention group; three-month follow-up \[T2\] for active control group) 4. Percentage of veterans who complete the MBTA assessment (baseline \[T1\] for intervention group; three-month follow-up \[T2\] for active control group) 5. Percentage of veterans who review the personalized well-being report (baseline \[T1\] for intervention group; three-month follow-up \[T2\] for active control group)
Satisfaction With MBTA Toolbaseline assessment (T1 only for intervention group)For the intervention group at the baseline assessment (T1), the investigators assessed satisfaction with the MBTA tool with items developed specifically for this pilot study. T1 (baseline) was the only timeframe these questions were administered for this group). The investigators asked open-ended questions such as: What did you like about the tool? What did you not like about the tool? Is there anything you would change about the tool?

Secondary

MeasureTime frameDescription
Theory of Planned Behavior Constructsmeasured at T1 (baseline) and T2 (three-month follow-up) for the intervention group and active control group; estimates reported below are three-month follow-up adjusted mean scoresThe investigators used Theory of Planned Behavior Questionnaire (Ajzen, 1991) to assess movement from baseline to the three-month follow-up in the constructs from the theory of planned behavior (intention, attitude toward the behavior, subjective norm, perceived behavioral control). Questions were slightly modified to focus on well-being. The investigators scored each of the aforementioned constructs/subscales separately. For each subscale, the investigators calculated the the mean of the items. Scores could range from 1 to 7 with higher scores indicating a more positive response.
University of Rhode Island Change Assessment Scale (URICA) - Readiness to Changemeasured at T1(baseline) and T2 (three-month follow-up) for the intervention group and active control group; estimates reported below are three-month follow-up adjusted mean scoresThe investigators administered the University of Rhode Island Change Assessment Scale (URICA; DiClemente et al., 2004) to measure movement in the stages of change. Questions in the URICA were slightly modified to focus on well-being. To score the URICA, the investigators will calculate a readiness to change score based on the four stages of change (precontemplation, contemplation, action, and maintenance). The investigators will calculate means for precontemplation responses, contemplation responses, action responses and maintenance responses and subtract the mean from the precontemplation score from the summation of the other three stages. This sum score represents an individual's readiness to change. Possible readiness to change scores range from -2 to +14, with higher scores indicating higher levels of readiness to change.
Support-Seeking Actions to Improve Well-BeingMeasured at T2 (three-month follow-up) for intervention group onlyFor the intervention group, the investigators assessed support seeking behavior with items developed specifically for this pilot study at T2 (three-month follow-up). Questions asked about the extent to which the tool has helped increase awareness about well-being related challenges or problems, the extent to which the tool has helped encourage improving well-being related problems or challenges, and which types of resources the participant has used since using the tool. Items were examined separately. A response of moderately or higher on the two Likert scale items was considered a positive response.
Attitudes Toward Seeking Professional Psychological Help-Short Formmeasured at T1 (baseline) and T2 (three-month follow-up) for the intervention group and active control group; estimates reported below are three-month follow-up adjusted mean scoresThe investigators assessed movement in support seeking perceptions from baseline (T1) to the three-month follow-up (T2) with the Attitudes Toward Seeking Professional Psychological Help - Short Form scale (Picco et al., 2016). Questions were slightly modified to focus on seeking support to address well-being challenges and problems. To calculate a total score, items 2, 4, 8, 9, and 10 were reverse scored. Scores were then summed together, with higher scores indicating more positive attitudes toward seeking professional help. Scores could range range for 0-30.
Stages Algorithmmeasured at T1 (baseline) and T2 (three-month follow-up) for the intervention group and active control group; challenges reported are from baseline (T1) and if they were were taking action to address these challenges are data from three-month follow-upThe investigators administered the Stages Algorithm (DiClemente et al., 1991) to measure movement in the stages of change from baseline to the three-month follow-up. Questions were modified slightly to assess for willingness to work on resolving problems or challenges related to areas of well-being (i.e., mental health/emotional well-being, physical health, vocation, social life, and finances). This measure is designed as a decision tree based on reported challenges, and is scored based on where participants fall within the decision tree. It classifies participants according to the following stages of change: precontemplation, contemplation, preparation, action, and maintenance stages.

Countries

United States

Participant flow

Recruitment details

Potential participants were recruited through invitations via mail between November 2022 and December 2022. 500 invitations were mailed (25 were undeliverable). Forty-six veterans accessed the study website URL and consented to participate.

Pre-assignment details

Potential participants were randomly assigned to a group prior to mailing (250 to Intervention Group arm and 250 to Active Control Group arm)

Participants by arm

ArmCount
Intervention Group
MBTA, MBTA satisfaction measures, and other assessment measures at T1; MBTA and other assessment measures at T2 Measurement-Based Transition Assistance (MBTA) asks Veterans about their well-being and then provides Veterans with individualized feedback on areas in which they would benefit from additional support with regard to their health, vocational, financial, and social circumstances, along with personalized recommendations for relevant programs, services, and supports.
24
Active Control Group
assessment measures only at T1; MBTA, MBTA satisfaction measures, and other assessment measures at T2 Measurement-Based Transition Assistance (MBTA) asks Veterans about their well-being and then provides Veterans with individualized feedback on areas in which they would benefit from additional support with regard to their health, vocational, financial, and social circumstances, along with personalized recommendations for relevant programs, services, and supports.
19
Total43

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up99
Overall StudyWithdrawal by Subject30

Baseline characteristics

CharacteristicIntervention GroupTotalActive Control Group
Age, Continuous41.71 years
STANDARD_DEVIATION 11.12
38.25 years
STANDARD_DEVIATION 10.33
35.16 years
STANDARD_DEVIATION 8.73
Ethnicity (NIH/OMB)
Hispanic or Latino
3 Participants8 Participants5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
20 Participants34 Participants14 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
1 Participants1 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants2 Participants2 Participants
Race (NIH/OMB)
Asian
1 Participants1 Participants0 Participants
Race (NIH/OMB)
Black or African American
5 Participants9 Participants4 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
1 Participants1 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants1 Participants1 Participants
Race (NIH/OMB)
White
17 Participants29 Participants12 Participants
Region of Enrollment
United States
24 Participants43 Participants19 Participants
Sex/Gender, Customized
Female
5 Participants11 Participants6 Participants
Sex/Gender, Customized
Male
15 Participants28 Participants13 Participants
Sex/Gender, Customized
Other or prefer not to say
1 Participants1 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 340 / 9
other
Total, other adverse events
0 / 340 / 9
serious
Total, serious adverse events
0 / 340 / 9

Outcome results

Primary

Number of Participants Assessed for the Feasibility of Study Procedures

Participation in the study will be evaluated to assess feasibility of the study procedures. To determine feasibility, at the end of data collection the investigators will calculate the following: 1. Percentage of veterans who enroll in the study out of those invited (baseline; T1) 2. Percentage of veterans who complete both T1 and T2 surveys (baseline \[T1\] and three-month follow-up \[T2\] data) 3. Percentage of veterans who access the MBTA assessment (baseline \[T1\] for intervention group; three-month follow-up \[T2\] for active control group) 4. Percentage of veterans who complete the MBTA assessment (baseline \[T1\] for intervention group; three-month follow-up \[T2\] for active control group) 5. Percentage of veterans who review the personalized well-being report (baseline \[T1\] for intervention group; three-month follow-up \[T2\] for active control group)

Time frame: baseline (T1) and three-month follow-up (T2)

Population: 500 letters mailed; number analyzed varies per row because of number of eligible participants within each category/row

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Intervention GroupNumber of Participants Assessed for the Feasibility of Study ProceduresPercent of veterans who complete both baseline and three-month follow-up surveys (T1 and T2 data)15 Participants
Intervention GroupNumber of Participants Assessed for the Feasibility of Study ProceduresPercent who complete MBTA assessment (Intervention: baseline; Active Control: three-month follow-up)21 Participants
Intervention GroupNumber of Participants Assessed for the Feasibility of Study ProceduresPercent who access MBTA assessment (Intervention: baseline; Active Control: three-month follow-up)22 Participants
Intervention GroupNumber of Participants Assessed for the Feasibility of Study ProceduresPercent who review the personal report (Intervention:baseline; Active Control:three-month follow-up)21 Participants
Intervention GroupNumber of Participants Assessed for the Feasibility of Study ProceduresPercent of veterans who enroll in the study out of those invited (T1; baseline)27 Participants
Active Control GroupNumber of Participants Assessed for the Feasibility of Study ProceduresPercent who review the personal report (Intervention:baseline; Active Control:three-month follow-up)10 Participants
Active Control GroupNumber of Participants Assessed for the Feasibility of Study ProceduresPercent of veterans who enroll in the study out of those invited (T1; baseline)19 Participants
Active Control GroupNumber of Participants Assessed for the Feasibility of Study ProceduresPercent of veterans who complete both baseline and three-month follow-up surveys (T1 and T2 data)10 Participants
Active Control GroupNumber of Participants Assessed for the Feasibility of Study ProceduresPercent who access MBTA assessment (Intervention: baseline; Active Control: three-month follow-up)10 Participants
Active Control GroupNumber of Participants Assessed for the Feasibility of Study ProceduresPercent who complete MBTA assessment (Intervention: baseline; Active Control: three-month follow-up)10 Participants
Primary

Satisfaction With MBTA Tool

For the intervention group at the baseline assessment (T1), the investigators assessed satisfaction with the MBTA tool with items developed specifically for this pilot study. T1 (baseline) was the only timeframe these questions were administered for this group). The investigators asked open-ended questions such as: What did you like about the tool? What did you not like about the tool? Is there anything you would change about the tool?

Time frame: baseline assessment (T1 only for intervention group)

Population: 16 Veterans in the intervention group provided data for open-ended questions at T1 (baseline). T1 (baseline) was the only timeframe when these questions were administered for this group.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Intervention GroupSatisfaction With MBTA ToolProvided positive feedback about MBTA prototype14 Participants
Intervention GroupSatisfaction With MBTA ToolProvided a critique about MBTA prototype5 Participants
Intervention GroupSatisfaction With MBTA ToolProvided constructive feedback about MBTA prototype4 Participants
Primary

Satisfaction With MBTA Tool

For the active control group, they were asked at the three-month follow-up (T2) their satisfaction with the MBTA tool with items developed specifically for this pilot study. T2 (three-month follow-up) was the only timeframe these questions were administered for this group). The investigators asked open-ended questions such as: What did you like about the tool? What did you not like about the tool? Is there anything you would change about the tool?

Time frame: three-month follow-up (T2 only for active control group)

Population: 7 Veterans in the active control group provided data for open-ended questions at T2 (three-month follow-up). T2 (three-month follow-up) was the only timeframe when these questions were administered for this group

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Intervention GroupSatisfaction With MBTA ToolProvided positive feedback about MBTA prototype7 Participants
Intervention GroupSatisfaction With MBTA ToolProvided a critique about MBTA prototype3 Participants
Intervention GroupSatisfaction With MBTA ToolProvided constructive feedback about MBTA prototype2 Participants
Secondary

Attitudes Toward Seeking Professional Psychological Help-Short Form

The investigators assessed movement in support seeking perceptions from baseline (T1) to the three-month follow-up (T2) with the Attitudes Toward Seeking Professional Psychological Help - Short Form scale (Picco et al., 2016). Questions were slightly modified to focus on seeking support to address well-being challenges and problems. To calculate a total score, items 2, 4, 8, 9, and 10 were reverse scored. Scores were then summed together, with higher scores indicating more positive attitudes toward seeking professional help. Scores could range range for 0-30.

Time frame: measured at T1 (baseline) and T2 (three-month follow-up) for the intervention group and active control group; estimates reported below are three-month follow-up adjusted mean scores

Population: Possible scores ranged from 0 to 30, with higher scores indicating more positive attitudes toward seeking professional help. Using ANCOVAs, data values represent three-month follow-up adjusted mean (follow-up) scores after controlling for baseline scores and age

ArmMeasureValue (MEAN)Dispersion
Intervention GroupAttitudes Toward Seeking Professional Psychological Help-Short Form19.24 score on a scaleStandard Error 0.95
Active Control GroupAttitudes Toward Seeking Professional Psychological Help-Short Form19.04 score on a scaleStandard Error 1
p-value: 0.891ANCOVA
Secondary

Stages Algorithm

The investigators administered the Stages Algorithm (DiClemente et al., 1991) to measure movement in the stages of change from baseline to the three-month follow-up. Questions were modified slightly to assess for willingness to work on resolving problems or challenges related to areas of well-being (i.e., mental health/emotional well-being, physical health, vocation, social life, and finances). This measure is designed as a decision tree based on reported challenges, and is scored based on where participants fall within the decision tree. It classifies participants according to the following stages of change: precontemplation, contemplation, preparation, action, and maintenance stages.

Time frame: measured at T1 (baseline) and T2 (three-month follow-up) for the intervention group and active control group; challenges reported are from baseline (T1) and if they were were taking action to address these challenges are data from three-month follow-up

Population: Data were collected for intervention and active control group at baseline and three-month follow-up. Among participants who identified a challenge within a domain. Then within that subgroup of those with challenges, we examined the number that moved forward at least one stage/were taking action to work on their challenges between baseline (T1) and the three-month follow-up (T2).

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Intervention GroupStages AlgorithmVocation (reported challenges at T1; baseline)7 Participants
Intervention GroupStages AlgorithmVocation(of those reporting challenges at T1, # that were taking action to work on challenges at T2)7 Participants
Intervention GroupStages AlgorithmFinances (reported challenges at T1; baseline)5 Participants
Intervention GroupStages AlgorithmFinances(of those reporting challenges at T1, # that were taking action to work on challenges at T2)5 Participants
Intervention GroupStages AlgorithmSocial (reported challenges at T1; baseline)11 Participants
Intervention GroupStages AlgorithmSocial (of those reporting challenges at T1, # that were taking action to work on challenges at T2)10 Participants
Intervention GroupStages AlgorithmMental Health (reported challenges at T1; baseline)9 Participants
Intervention GroupStages AlgorithmMental Health(of those with challenges at T1, # that were taking action to work on challenges at T2)7 Participants
Intervention GroupStages AlgorithmPhysical Health (reported challenges at T1; baseline)13 Participants
Intervention GroupStages AlgorithmPhysical Health(of those with T1 challenges, # that were taking action to work on challenges at T2)10 Participants
Active Control GroupStages AlgorithmMental Health(of those with challenges at T1, # that were taking action to work on challenges at T2)6 Participants
Active Control GroupStages AlgorithmVocation (reported challenges at T1; baseline)5 Participants
Active Control GroupStages AlgorithmSocial (of those reporting challenges at T1, # that were taking action to work on challenges at T2)4 Participants
Active Control GroupStages AlgorithmVocation(of those reporting challenges at T1, # that were taking action to work on challenges at T2)5 Participants
Active Control GroupStages AlgorithmPhysical Health(of those with T1 challenges, # that were taking action to work on challenges at T2)7 Participants
Active Control GroupStages AlgorithmFinances (reported challenges at T1; baseline)3 Participants
Active Control GroupStages AlgorithmMental Health (reported challenges at T1; baseline)7 Participants
Active Control GroupStages AlgorithmFinances(of those reporting challenges at T1, # that were taking action to work on challenges at T2)2 Participants
Active Control GroupStages AlgorithmPhysical Health (reported challenges at T1; baseline)7 Participants
Active Control GroupStages AlgorithmSocial (reported challenges at T1; baseline)5 Participants
Secondary

Support-Seeking Actions to Improve Well-Being

For the intervention group, the investigators assessed support seeking behavior with items developed specifically for this pilot study at T2 (three-month follow-up). Questions asked about the extent to which the tool has helped increase awareness about well-being related challenges or problems, the extent to which the tool has helped encourage improving well-being related problems or challenges, and which types of resources the participant has used since using the tool. Items were examined separately. A response of moderately or higher on the two Likert scale items was considered a positive response.

Time frame: Measured at T2 (three-month follow-up) for intervention group only

Population: 15 veterans in the intervention group provided data for support-seeking actions at T2 (three-month follow-up); number of participants analyzed is different because type of service percentage applies only to those that used services (n=10). These measures were only administered to the intervention group at T2 (three-month follow-up). These measures were not administered to the active control group at either time point.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Intervention GroupSupport-Seeking Actions to Improve Well-BeingReported MBTA prototype increased awareness about their well-being related challenges or problems6 Participants
Intervention GroupSupport-Seeking Actions to Improve Well-BeingReported MBTA prototype helped encourage them to improve well-being related problems or challenges7 Participants
Intervention GroupSupport-Seeking Actions to Improve Well-BeingReported using a resource/service (not previously using before study) as a result the MBTA prototype10 Participants
Intervention GroupSupport-Seeking Actions to Improve Well-BeingUsed a mental health resource/service5 Participants
Intervention GroupSupport-Seeking Actions to Improve Well-BeingUsed a financial resource/service2 Participants
Intervention GroupSupport-Seeking Actions to Improve Well-BeingUsed a health behavior resource/service1 Participants
Intervention GroupSupport-Seeking Actions to Improve Well-BeingUsed other general health resource/service1 Participants
Intervention GroupSupport-Seeking Actions to Improve Well-BeingUsed a resource/service related to their social life1 Participants
Intervention GroupSupport-Seeking Actions to Improve Well-BeingUsed a resource/service under an 'other' category3 Participants
Intervention GroupSupport-Seeking Actions to Improve Well-BeingUsed a vocation-related resource/service0 Participants
Secondary

Theory of Planned Behavior Constructs

The investigators used Theory of Planned Behavior Questionnaire (Ajzen, 1991) to assess movement from baseline to the three-month follow-up in the constructs from the theory of planned behavior (intention, attitude toward the behavior, subjective norm, perceived behavioral control). Questions were slightly modified to focus on well-being. The investigators scored each of the aforementioned constructs/subscales separately. For each subscale, the investigators calculated the the mean of the items. Scores could range from 1 to 7 with higher scores indicating a more positive response.

Time frame: measured at T1 (baseline) and T2 (three-month follow-up) for the intervention group and active control group; estimates reported below are three-month follow-up adjusted mean scores

Population: Scores were calculated at T1 (baseline) and T2 (three-month follow-up) for intervention and active control group. Scores could range from 1 to 7 with higher scores indicating a more positive response. Number of participants analyzed for each row varies based on the number of participants that provided data for that construct at both time points. Using ANCOVAs, data values represent three-month follow-up adjusted mean (follow-up) scores after controlling for baseline scores and age.

ArmMeasureGroupValue (MEAN)Dispersion
Intervention GroupTheory of Planned Behavior ConstructsIntentions4.95 score on a scaleStandard Error 0.35
Intervention GroupTheory of Planned Behavior ConstructsAttitudes5.97 score on a scaleStandard Error 0.31
Intervention GroupTheory of Planned Behavior ConstructsSocial norms5.14 score on a scaleStandard Error 0.33
Intervention GroupTheory of Planned Behavior ConstructsPerceived behavioral control5.53 score on a scaleStandard Error 0.32
Active Control GroupTheory of Planned Behavior ConstructsPerceived behavioral control5.05 score on a scaleStandard Error 0.34
Active Control GroupTheory of Planned Behavior ConstructsIntentions5.61 score on a scaleStandard Error 0.36
Active Control GroupTheory of Planned Behavior ConstructsSocial norms4.68 score on a scaleStandard Error 0.36
Active Control GroupTheory of Planned Behavior ConstructsAttitudes6.03 score on a scaleStandard Error 0.31
Comparison: Null hypothesis: Intervention and active control group intention follow-up means are equal when controlling for covariates (i.e., baseline intention scores and age)p-value: 0.214ANCOVA
Comparison: Null hypothesis: Intervention and active control group attitude follow-up means are equal when controlling for covariates (i.e., baseline attitude scores and age)p-value: 0.894ANCOVA
Comparison: Null hypothesis: Intervention and active control group social norms follow-up means are equal when controlling for covariates (i.e., baseline social norms scores and age)p-value: 0.359ANCOVA
Comparison: Null hypothesis: Intervention and active control group perceived behavioral control follow-up means are equal when controlling for covariates (i.e., baseline perceived behavioral control scores and age)p-value: 0.322ANCOVA
Secondary

University of Rhode Island Change Assessment Scale (URICA) - Readiness to Change

The investigators administered the University of Rhode Island Change Assessment Scale (URICA; DiClemente et al., 2004) to measure movement in the stages of change. Questions in the URICA were slightly modified to focus on well-being. To score the URICA, the investigators will calculate a readiness to change score based on the four stages of change (precontemplation, contemplation, action, and maintenance). The investigators will calculate means for precontemplation responses, contemplation responses, action responses and maintenance responses and subtract the mean from the precontemplation score from the summation of the other three stages. This sum score represents an individual's readiness to change. Possible readiness to change scores range from -2 to +14, with higher scores indicating higher levels of readiness to change.

Time frame: measured at T1(baseline) and T2 (three-month follow-up) for the intervention group and active control group; estimates reported below are three-month follow-up adjusted mean scores

Population: An overall readiness to change score was calculated at T1 (baseline) and T2 (three-month follow-up). Using ANCOVAs, data values represent three-month follow-up adjusted mean scores after controlling for baseline scores and age.

ArmMeasureValue (MEAN)Dispersion
Intervention GroupUniversity of Rhode Island Change Assessment Scale (URICA) - Readiness to Change11.20 score on a scaleStandard Error 0.72
Active Control GroupUniversity of Rhode Island Change Assessment Scale (URICA) - Readiness to Change10.69 score on a scaleStandard Error 0.68
p-value: 0.617ANCOVA

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026