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Testing the Effectiveness of The Welcome Basket Intervention

Testing the Effectiveness of a Brief, Peer Support Intervention to Facilitate Transition Form Psychiatric Hospitalization

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02946255
Enrollment
110
Registered
2016-10-27
Start date
2017-05-16
Completion date
2019-09-01
Last updated
2024-03-19

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

Conditions

Psychosis

Keywords

Psychosis, Psychosis NOS, Schizophrenia, Hospital discharge, Inpatient psychiatry

Brief summary

The investigators propose to examine the effectiveness of a brief intervention that might better facilitate the transition into the community for people with schizophrenia or bipolar disorder with psychotic features. The intervention is called the Welcome Basket. It involves Peer Support Workers connecting with and supporting hospitalized individuals in the days before discharge and again in the community in the first month immediately following discharge. The investigators will compare the outcomes of discharge from hospital as usual with the full version of the welcome basket and a preliminary test of an abbreviated 2 visit version of the intervention.

Detailed description

Discharge from hospital has been highlighted as a critical time in the care of individuals with mental illness. The peak period of risk for readmission for individuals with severe mental illness is in the first month and the highest risk for post-discharge suicide is within the first 2 weeks with discontinuity of contact with providers highlighted as a key risk factor. One half of individuals with schizophrenia miss their first-scheduled outpatient appointment following discharge and this time is a key period of risk for medication non-compliance. Common problems that occur at the time of discharge from psychiatric care settings include poor communication between inpatient and outpatient providers and inadequate involvement and support of families. The research literature on effective practices linked with discharge is strikingly sparse given the evidence that this is a period of heightened risk. The investigators hypothesize that the Welcome Basket intervention will improve the discharge-related outcomes of individuals with schizophrenia or bipolar disorder with psychotic features compared to treatment as usual. Investigators will also explore the outcomes of an abbreviated, 2-visit version of the intervention. This study will employ a randomized, controlled trial design. Inpatient clients with a diagnosis of schizophrenia spectrum mental illness or bipolar disorder with psychotic features will be randomized with a 2:2:1 ratio to: treatment as usual, the full welcome basket intervention, and the abbreviated intervention. Measures will include re-hospitalization, symptomatology, quality of life, and community functioning. Assessments at baseline, 4 weeks post-discharge, and 6 months post-discharge will facilitate studies of relative effectiveness and sustainment of gains. This design will facilitate an examination of both overall outcomes as well as some preliminary dismantling of mechanisms of action.

Interventions

BEHAVIORALWelcome Basket (WB)

Peer Support Workers (PSWs) hold 1-2 meetings with clients (30-60 minutes) in the 2-week period before they are discharged from hospital. They describe the program and undertake an assessment. From this assessment the two core components of the intervention are initiated. First, a welcome basket is created for the client. The PSW also forms a plan with the client about tours of their neighbourhood to familiarize them with the local resources and support them in building confidence in accessing their local communities. These activities will take place through weekly visits (2 hours/visit) in the 4 weeks immediately following discharge. WB will be provided in combination with core Cognitive Adaptation Training (CAT) compensatory interventions.

BEHAVIORALWelcome Basket Brief (WBbr)

The brief version of the Welcome Basket (WBbr) was developed based upon the observation in feasibility testing that for some participants much of the benefit of this approach appeared to be centred upon the visits immediately prior and subsequent to discharge. In the WBbr the same core components will be present, albeit in an abbreviated form with one 30-60 minute visit in the week prior to discharge and a single, 3-hour visit in the week subsequent to discharge in which the welcome basket would be delivered, core CAT strategies discussed and implemented, and some basic orientation to community resources undertaken. This brief version of the intervention has not to date been studied.

BEHAVIORALTreatment As Usual

Treatment as usual (TAU) involves the typical discharge procedures for clients from Unit 2, Forensic and EPU wards at CAMH. It includes referral to outpatient psychiatric services and relevant community supports with the transition facilitated by inpatient social work staff.

Sponsors

Centre for Addiction and Mental Health
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Participants will be adults, 18 years of age or older, with a chart diagnosis of a schizophrenia spectrum mental illness or bipolar disorder with psychotic features confirmed by Module B (psychotic symptoms) of the Structured Clinical Interview for DSM-5 (SCID-5) (First, William, Karg, & Spitzer, 2015). All participants will be on CAMH inpatient units at the time of recruitment and will have been in continuous inpatient care for close to or more than 2 weeks. This timeframe is guided by the rationale and experience indicating that an overly brief period of hospitalization circumscribes the relevance of the intervention. 2. Participants will be returning to places of residence in the Greater Toronto Area (catchment of CAMH) or can travel to the GTA if they will reside outside the catchment area. 3. Participants must have been referred to outpatient case management. 4. Proposed housing arrangements must be stable and conducive to the intervention. If homelessness or emergency shelter residence appears likely, or boarding home policy precludes any external staff from entering the premises, such individuals will be excluded. 5. Proficiency in English.

Exclusion criteria

1\. Do not meet the above criteria.

Design outcomes

Primary

MeasureTime frameDescription
Multnomah Community Ability Scale - Participant Interview BasedBaselineCommunity Functioning and change in adaptive functioning will be assessed with the Multnomah Community Ability Scale (MCAS), a 17-item scale assessing domains of functionality including health, adjustment to living, social competence, and behavioral problems (completed at all time points). This measure best reflects the primary aim of this intervention: to support a greater degree of illness self-management, independence, and level of community activity. The MCAS will be scored based upon interviews with participants and by the primary clinician (inpatient for baseline and case managers for post and follow up measures). The total score is reported here and is the sum of the 4 subscale totals (Health, Adaptation, Social Skills, Behaviour). The min total score is 17 and the max is 85 with higher values representing better outcomes.
Multnomah Community Ability Scale - Clinician BasedBaselineCommunity Functioning and change in adaptive functioning will be assessed with the Multnomah Community Ability Scale (MCAS), a 17-item scale assessing domains of functionality including health, adjustment to living, social competence, and behavioral problems (completed at all time points). This measure best reflects the primary aim of this intervention: to support a greater degree of illness self-management, independence, and level of community activity. The MCAS will be scored based upon interviews with participants and by the primary clinician (inpatient for baseline and case managers for post and follow up measures). The total score is reported here and is the sum of the 4 subscale totals (Health, Adaptation, Social Skills, Behaviour). The min total score is 17 and the max is 85 with higher values representing better outcomes.

Secondary

MeasureTime frameDescription
Social Support SurveyBaselineQuality of Life will also be assessed using the Social Support Survey, a 19 item scale that measures emotional/information support, tangible support, affectionate support and positive social interaction. Overall support index (i.e., Total Score) is reported here and is calculated from averaging all items and then applying a transformation \[i.e., minimum possible score subtracted from observed score (first difference) and maximum possible score (second difference) and then the first difference divided by the second difference and that quotient multiplied by 100\] such that the min score is 0 and the max is 100. Higher scores indicate better outcomes (i.e., more frequent availability of different types of support).
Brief Symptom InventoryBaselineChanges in symptomatology will be assessed with the 53 item Brief Symptom Inventory (BSI); this widely used instrument has extensively demonstrated validity and reliability properties and assesses a wide range of symptom areas. Participants rank how distressing symptoms are from 0 (not at all) to 4 (a great deal). The 52 items are organized into 9 symptom dimensions: Somatization, Obsession-Compulsions, Interpersonal Sensitivity Items, Depression, Anxiety, Hostility, Phobic Anxiety, Paranoid Ideation, and Psychoticism. Dimension scores are calculated by summing the values for the items included in that dimension and dividing by the number of items endorsed in that dimension. The Global Severity Index (GSI) is reported here. The GSI is calculated by summing all the dimensions plus four additional items and dividing by the total number of items responded to. The min value is 0 and the max value is 72. Higher scores indicate worse outcomes (i.e., more distressing symptoms).
Hospitalizations and Emergency Room VisitsBaseline to 6 Month Follow-UpThe percentage of participants that were re-hospitalized or visited the emergency room during the study were captured through case manager report and verified through hospital electronic database if a CAMH hospitalization.
Personal Recovery Outcome MeasureBaselineThe brief, 10-item version of the Personal Recovery Outcome Measure was used to assess change in recovery engagement. Total score is reported here. Total score is calculated by summing all the responses. Min total score value is 0 and max total score value is 40. Higher scores indicate better outcomes (i.e., more engagement in recovery).
Community Integration Scale4 Week Follow-UpCommunity involvement will be assessed with the 11 item Community Integration Scale which was developed for the At Home study with a comparable population to assesses psychological and behavioural community engagement. The first 7 items measure physical integration (community presence) and the remaining 4 items measure psychological integration (sense of belonging). Community Involvement was assessed post intervention and at follow up and not during inpatient stay since it would not be valid due to contextual confounds with items. Total scores (i.e, the average of the responses) are reported here. The min total score value is -1 and the max is 2.5. Higher scores indicate better outcomes (i.e., greater community engagement)
Global Appraisal of Individual Needs (GAIN) - Short Screener Substance Disorder SubscaleBaselineThe 5-item Global Appraisal of Individual Needs Short Screener (GAIN-SS) Substance Disorder Subscale (5-items) will be used to measure common psychological, behavioral, and personal problems related to alcohol and drug use. Each item is rated from 4 to 0 with 4, 3 and 2 representing use or problems in the past month, 2-3 months ago and 4-12 months ago, respectively. Items rated 1 represent problems over a year ago and items rated 0 indicate never having that problem. The subscale score is the total number of responses that indicate substance use problems within the last year. Substance Disorder Subscale scores for each arm are reported here. The min value is 0 and the max value is 5. Higher scores indicate worse outcomes (i.e., more severe problems related to substance use).
The Satisfaction With Life Scale4 Week Follow-UpQuality of Life will be assessed with the Satisfaction With Life scale, an 18-item scale comprised of 4 subscales assessing living situation (4 items), social relationships (6 items), work (2 items), self and present life (6 items). Items are rated from 0 (not at all) to 1 (very little) to 2 (average or OK) to 3 (a lot) to 4 (a great deal). Subscale scores are reported here. The min value for all subscales is 0. The max value for the Living Situation subscale is 16. The max value for both the Social Relationships subscale and the Self and Present Life subscale is 24. The max value for the Work subscale is 8. Higher subscale scores indicate better outcomes (i.e., greater satisfaction with that area of life).

Countries

Canada

Participant flow

Participants by arm

ArmCount
Welcome Basket Brief (WBbr)
The brief version of the Welcome Basket (WBbr) was developed based upon the observation in feasibility testing that for some participants much of the benefit of this approach appeared to be centred upon the visits immediately prior and subsequent to discharge. In the WBbr the same core components will be present, albeit in an abbreviated form with one 30-60 minute visit in the week prior to discharge and a single, 3-hour visit in the week subsequent to discharge in which the welcome basket would be delivered, core CAT strategies discussed and implemented, and some basic orientation to community resources undertaken. This brief version of the intervention has not to date been studied. Welcome Basket Brief (WBbr): The brief version of the Welcome Basket (WBbr) was developed based upon the observation in feasibility testing that for some participants much of the benefit of this approach appeared to be centred upon the visits immediately prior and subsequent to discharge. In the WBbr the same core components will be present, albeit in an abbreviated form with one 30-60 minute visit in the week prior to discharge and a single, 3-hour visit in the week subsequent to discharge in which the welcome basket would be delivered, core CAT strategies discussed and implemented, and some basic orientation to community resources undertaken. This brief version of the intervention has not to date been studied.
22
Welcome Basket (WB)
Peer Support Workers (PSWs) hold 1-2 meetings with clients (30-60 minutes) in the 2-week period before they are discharged from hospital. They describe the program and undertake an assessment. From this assessment the two core components of the intervention are initiated. First, a welcome basket is created for the client. The PSW also forms a plan with the client about tours of their neighbourhood to familiarize them with the local resources and support them in building confidence in accessing their local communities. These activities will take place through weekly visits (2 hours/visit) in the 4 weeks immediately following discharge. WB will be provided in combination with core Cognitive Adaptation Training (CAT) compensatory interventions.
41
Treatment As Usual
Treatment as usual (TAU) involves the typical discharge procedures for clients from Unit 2, Forensic and EPU wards at CAMH. It includes referral to outpatient psychiatric services and relevant community supports with the transition facilitated by inpatient social work staff. Treatment As Usual: Treatment as usual (TAU) involves the typical discharge procedures for clients from Unit 2, Forensic and EPU wards at CAMH. It includes referral to outpatient psychiatric services and relevant community supports with the transition facilitated by inpatient social work staff.
44
Total107

Baseline characteristics

CharacteristicWelcome Basket Brief (WBbr)TotalTreatment As UsualWelcome Basket (WB)
Age, Continuous32.09 years
STANDARD_DEVIATION 15.79
34.60 years
STANDARD_DEVIATION 14.82
34.14 years
STANDARD_DEVIATION 14.2
36.44 years
STANDARD_DEVIATION 15.08
Education
High school completed
6 Participants29 Participants11 Participants12 Participants
Education
High school not completed
3 Participants23 Participants7 Participants13 Participants
Education
Post-secondary attended
8 Participants32 Participants18 Participants6 Participants
Education
Post-secondary completed
4 Participants21 Participants8 Participants9 Participants
Education
Unknown
1 Participants2 Participants0 Participants1 Participants
Employment
Employed
1 Participants9 Participants5 Participants3 Participants
Employment
Other Work Status
8 Participants29 Participants10 Participants11 Participants
Employment
Unemployed
13 Participants68 Participants28 Participants27 Participants
Employment
Unknown
0 Participants1 Participants1 Participants0 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants4 Participants1 Participants2 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
17 Participants97 Participants41 Participants39 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
4 Participants6 Participants2 Participants0 Participants
Not in a Relationship18 Participants90 Participants37 Participants35 Participants
Number of arrests in the past year1 Arrests11 Arrests5 Arrests5 Arrests
Number of Hospitalizations in the past year1.91 Hospitalizations
STANDARD_DEVIATION 1.48
1.76 Hospitalizations
STANDARD_DEVIATION 1.29
1.91 Hospitalizations
STANDARD_DEVIATION 1.43
1.54 Hospitalizations
STANDARD_DEVIATION 1
Sex: Female, Male
Female
6 Participants41 Participants16 Participants19 Participants
Sex: Female, Male
Male
16 Participants66 Participants28 Participants22 Participants
Sexuality
Bisexual
1 Participants9 Participants5 Participants3 Participants
Sexuality
Other
3 Participants13 Participants6 Participants4 Participants
Sexuality
Straight/Heterosexual
18 Participants85 Participants33 Participants34 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 222 / 410 / 44
other
Total, other adverse events
0 / 220 / 410 / 44
serious
Total, serious adverse events
10 / 2213 / 4111 / 44

Outcome results

Primary

Multnomah Community Ability Scale - Clinician Based

Community Functioning and change in adaptive functioning will be assessed with the Multnomah Community Ability Scale (MCAS), a 17-item scale assessing domains of functionality including health, adjustment to living, social competence, and behavioral problems (completed at all time points). This measure best reflects the primary aim of this intervention: to support a greater degree of illness self-management, independence, and level of community activity. The MCAS will be scored based upon interviews with participants and by the primary clinician (inpatient for baseline and case managers for post and follow up measures). The total score is reported here and is the sum of the 4 subscale totals (Health, Adaptation, Social Skills, Behaviour). The min total score is 17 and the max is 85 with higher values representing better outcomes.

Time frame: Baseline

ArmMeasureValue (MEAN)Dispersion
Welcome Basket Brief (WBbr)Multnomah Community Ability Scale - Clinician Based63.05 Total ScoreStandard Deviation 8.76
Welcome Basket (WB)Multnomah Community Ability Scale - Clinician Based60.20 Total ScoreStandard Deviation 14.14
Treatment As UsualMultnomah Community Ability Scale - Clinician Based60.11 Total ScoreStandard Deviation 15.73
Primary

Multnomah Community Ability Scale - Clinician Based

Community Functioning and change in adaptive functioning will be assessed with the Multnomah Community Ability Scale (MCAS), a 17-item scale assessing domains of functionality including health, adjustment to living, social competence, and behavioral problems (completed at all time points). This measure best reflects the primary aim of this intervention: to support a greater degree of illness self-management, independence, and level of community activity. The MCAS will be scored based upon interviews with participants and by the primary clinician (inpatient for baseline and case managers for post and follow up measures). The total score is reported here and is the sum of the 4 subscale totals (Health, Adaptation, Social Skills, Behaviour). The min total score is 17 and the max is 85 with higher values representing better outcomes.

Time frame: 4 Week Follow-Up

ArmMeasureValue (MEAN)Dispersion
Welcome Basket Brief (WBbr)Multnomah Community Ability Scale - Clinician Based60.15 Total ScoreStandard Error 3.54
Welcome Basket (WB)Multnomah Community Ability Scale - Clinician Based64.53 Total ScoreStandard Error 2.89
Treatment As UsualMultnomah Community Ability Scale - Clinician Based65.99 Total ScoreStandard Error 1.9
Primary

Multnomah Community Ability Scale - Clinician Based

Community Functioning and change in adaptive functioning will be assessed with the Multnomah Community Ability Scale (MCAS), a 17-item scale assessing domains of functionality including health, adjustment to living, social competence, and behavioral problems (completed at all time points). This measure best reflects the primary aim of this intervention: to support a greater degree of illness self-management, independence, and level of community activity. The MCAS will be scored based upon interviews with participants and by the primary clinician (inpatient for baseline and case managers for post and follow up measures). The total score is reported here and is the sum of the 4 subscale totals (Health, Adaptation, Social Skills, Behaviour). The min total score is 17 and the max is 85 with higher values representing better outcomes.

Time frame: 6 Month Follow-Up

ArmMeasureValue (MEAN)Dispersion
Welcome Basket Brief (WBbr)Multnomah Community Ability Scale - Clinician Based66.64 Total ScoreStandard Error 3.65
Welcome Basket (WB)Multnomah Community Ability Scale - Clinician Based59.84 Total ScoreStandard Error 3.07
Treatment As UsualMultnomah Community Ability Scale - Clinician Based65.97 Total ScoreStandard Error 2.4
Primary

Multnomah Community Ability Scale - Participant Interview Based

Community Functioning and change in adaptive functioning will be assessed with the Multnomah Community Ability Scale (MCAS), a 17-item scale assessing domains of functionality including health, adjustment to living, social competence, and behavioral problems (completed at all time points). This measure best reflects the primary aim of this intervention: to support a greater degree of illness self-management, independence, and level of community activity. The MCAS will be scored based upon interviews with participants and by the primary clinician (inpatient for baseline and case managers for post and follow up measures). The total score is reported here and is the sum of the 4 subscale totals (Health, Adaptation, Social Skills, Behaviour). The min total score is 17 and the max is 85 with higher values representing better outcomes.

Time frame: Baseline

ArmMeasureValue (MEAN)Dispersion
Welcome Basket Brief (WBbr)Multnomah Community Ability Scale - Participant Interview Based65.45 Total ScoreStandard Deviation 15.67
Welcome Basket (WB)Multnomah Community Ability Scale - Participant Interview Based67.83 Total ScoreStandard Deviation 7.67
Treatment As UsualMultnomah Community Ability Scale - Participant Interview Based64.66 Total ScoreStandard Deviation 11.81
Primary

Multnomah Community Ability Scale - Participant Interview Based

Community Functioning and change in adaptive functioning will be assessed with the Multnomah Community Ability Scale (MCAS), a 17-item scale assessing domains of functionality including health, adjustment to living, social competence, and behavioral problems (completed at all time points). This measure best reflects the primary aim of this intervention: to support a greater degree of illness self-management, independence, and level of community activity. The MCAS will be scored based upon interviews with participants and by the primary clinician (inpatient for baseline and case managers for post and follow up measures). The total score is reported here and is the sum of the 4 subscale totals (Health, Adaptation, Social Skills, Behaviour). The min total score is 17 and the max is 85 with higher values representing better outcomes.

Time frame: 4 Week Follow-Up

ArmMeasureValue (MEAN)Dispersion
Welcome Basket Brief (WBbr)Multnomah Community Ability Scale - Participant Interview Based70.67 Total ScoreStandard Error 2.08
Welcome Basket (WB)Multnomah Community Ability Scale - Participant Interview Based71.04 Total ScoreStandard Error 1.7
Treatment As UsualMultnomah Community Ability Scale - Participant Interview Based71.49 Total ScoreStandard Error 1.2
Primary

Multnomah Community Ability Scale - Participant Interview Based

Community Functioning and change in adaptive functioning will be assessed with the Multnomah Community Ability Scale (MCAS), a 17-item scale assessing domains of functionality including health, adjustment to living, social competence, and behavioral problems (completed at all time points). This measure best reflects the primary aim of this intervention: to support a greater degree of illness self-management, independence, and level of community activity. The MCAS will be scored based upon interviews with participants and by the primary clinician (inpatient for baseline and case managers for post and follow up measures). The total score is reported here and is the sum of the 4 subscale totals (Health, Adaptation, Social Skills, Behaviour). The min total score is 17 and the max is 85 with higher values representing better outcomes.

Time frame: 6 Month Follow-Up

ArmMeasureValue (MEAN)Dispersion
Welcome Basket Brief (WBbr)Multnomah Community Ability Scale - Participant Interview Based72.03 Total ScoreStandard Error 2.43
Welcome Basket (WB)Multnomah Community Ability Scale - Participant Interview Based68.65 Total ScoreStandard Error 2.09
Treatment As UsualMultnomah Community Ability Scale - Participant Interview Based70.41 Total ScoreStandard Error 1.6
Secondary

Brief Symptom Inventory

Changes in symptomatology will be assessed with the 53 item Brief Symptom Inventory (BSI); this widely used instrument has extensively demonstrated validity and reliability properties and assesses a wide range of symptom areas. Participants rank how distressing symptoms are from 0 (not at all) to 4 (a great deal). The 52 items are organized into 9 symptom dimensions: Somatization, Obsession-Compulsions, Interpersonal Sensitivity Items, Depression, Anxiety, Hostility, Phobic Anxiety, Paranoid Ideation, and Psychoticism. Dimension scores are calculated by summing the values for the items included in that dimension and dividing by the number of items endorsed in that dimension. The Global Severity Index (GSI) is reported here. The GSI is calculated by summing all the dimensions plus four additional items and dividing by the total number of items responded to. The min value is 0 and the max value is 72. Higher scores indicate worse outcomes (i.e., more distressing symptoms).

Time frame: 4 Week Follow-Up

ArmMeasureValue (MEAN)Dispersion
Welcome Basket Brief (WBbr)Brief Symptom Inventory0.94 Global Severity IndexStandard Error 0.16
Welcome Basket (WB)Brief Symptom Inventory0.77 Global Severity IndexStandard Error 0.12
Treatment As UsualBrief Symptom Inventory0.88 Global Severity IndexStandard Error 0.11
Secondary

Brief Symptom Inventory

Changes in symptomatology will be assessed with the 53 item Brief Symptom Inventory (BSI); this widely used instrument has extensively demonstrated validity and reliability properties and assesses a wide range of symptom areas. Participants rank how distressing symptoms are from 0 (not at all) to 4 (a great deal). The 52 items are organized into 9 symptom dimensions: Somatization, Obsession-Compulsions, Interpersonal Sensitivity Items, Depression, Anxiety, Hostility, Phobic Anxiety, Paranoid Ideation, and Psychoticism. Dimension scores are calculated by summing the values for the items included in that dimension and dividing by the number of items endorsed in that dimension. The Global Severity Index (GSI) is reported here. The GSI is calculated by summing all the dimensions plus four additional items and dividing by the total number of items responded to. The min value is 0 and the max value is 72. Higher scores indicate worse outcomes (i.e., more distressing symptoms).

Time frame: 6 Month Follow-Up

ArmMeasureValue (MEAN)Dispersion
Welcome Basket Brief (WBbr)Brief Symptom Inventory0.83 Global Severity IndexStandard Error 0.22
Welcome Basket (WB)Brief Symptom Inventory0.93 Global Severity IndexStandard Error 0.18
Treatment As UsualBrief Symptom Inventory1.03 Global Severity IndexStandard Error 0.17
Secondary

Brief Symptom Inventory

Changes in symptomatology will be assessed with the 53 item Brief Symptom Inventory (BSI); this widely used instrument has extensively demonstrated validity and reliability properties and assesses a wide range of symptom areas. Participants rank how distressing symptoms are from 0 (not at all) to 4 (a great deal). The 52 items are organized into 9 symptom dimensions: Somatization, Obsession-Compulsions, Interpersonal Sensitivity Items, Depression, Anxiety, Hostility, Phobic Anxiety, Paranoid Ideation, and Psychoticism. Dimension scores are calculated by summing the values for the items included in that dimension and dividing by the number of items endorsed in that dimension. The Global Severity Index (GSI) is reported here. The GSI is calculated by summing all the dimensions plus four additional items and dividing by the total number of items responded to. The min value is 0 and the max value is 72. Higher scores indicate worse outcomes (i.e., more distressing symptoms).

Time frame: Baseline

ArmMeasureValue (MEAN)Dispersion
Welcome Basket Brief (WBbr)Brief Symptom Inventory67.05 Global Severity IndexStandard Deviation 49.39
Welcome Basket (WB)Brief Symptom Inventory62.41 Global Severity IndexStandard Deviation 42.56
Treatment As UsualBrief Symptom Inventory56.93 Global Severity IndexStandard Deviation 38.19
Secondary

Community Integration Scale

Community involvement will be assessed with the 11 item Community Integration Scale which was developed for the At Home study with a comparable population to assesses psychological and behavioural community engagement. The first 7 items measure physical integration (community presence) and the remaining 4 items measure psychological integration (sense of belonging). Community Involvement was assessed post intervention and at follow up and not during inpatient stay since it would not be valid due to contextual confounds with items. Total scores (i.e, the average of the responses) are reported here. The min total score value is -1 and the max is 2.5. Higher scores indicate better outcomes (i.e., greater community engagement)

Time frame: 6 Month Follow-Up

ArmMeasureValue (MEAN)Dispersion
Welcome Basket Brief (WBbr)Community Integration Scale1.39 Total ScoreStandard Error 0.16
Welcome Basket (WB)Community Integration Scale1.32 Total ScoreStandard Error 0.13
Treatment As UsualCommunity Integration Scale1.49 Total ScoreStandard Error 0.99
Secondary

Community Integration Scale

Community involvement will be assessed with the 11 item Community Integration Scale which was developed for the At Home study with a comparable population to assesses psychological and behavioural community engagement. The first 7 items measure physical integration (community presence) and the remaining 4 items measure psychological integration (sense of belonging). Community Involvement was assessed post intervention and at follow up and not during inpatient stay since it would not be valid due to contextual confounds with items. Total scores (i.e, the average of the responses) are reported here. The min total score value is -1 and the max is 2.5. Higher scores indicate better outcomes (i.e., greater community engagement)

Time frame: 4 Week Follow-Up

ArmMeasureValue (MEAN)Dispersion
Welcome Basket Brief (WBbr)Community Integration Scale1.44 Total ScoreStandard Error 0.12
Welcome Basket (WB)Community Integration Scale1.45 Total ScoreStandard Error 0.1
Treatment As UsualCommunity Integration Scale1.31 Total ScoreStandard Error 0.75
Secondary

Global Appraisal of Individual Needs (GAIN) - Short Screener Substance Disorder Subscale

The 5-item Global Appraisal of Individual Needs Short Screener (GAIN-SS) Substance Disorder Subscale (5-items) will be used to measure common psychological, behavioral, and personal problems related to alcohol and drug use. Each item is rated from 4 to 0 with 4, 3 and 2 representing use or problems in the past month, 2-3 months ago and 4-12 months ago, respectively. Items rated 1 represent problems over a year ago and items rated 0 indicate never having that problem. The subscale score is the total number of responses that indicate substance use problems within the last year. Substance Disorder Subscale scores for each arm are reported here. The min value is 0 and the max value is 5. Higher scores indicate worse outcomes (i.e., more severe problems related to substance use).

Time frame: Baseline

ArmMeasureValue (MEAN)Dispersion
Welcome Basket Brief (WBbr)Global Appraisal of Individual Needs (GAIN) - Short Screener Substance Disorder Subscale1.23 Subscale scoreStandard Deviation 1.77
Welcome Basket (WB)Global Appraisal of Individual Needs (GAIN) - Short Screener Substance Disorder Subscale1.05 Subscale scoreStandard Deviation 1.47
Treatment As UsualGlobal Appraisal of Individual Needs (GAIN) - Short Screener Substance Disorder Subscale1.88 Subscale scoreStandard Deviation 2.01
Secondary

Global Appraisal of Individual Needs (GAIN) - Short Screener Substance Disorder Subscale

The 5-item Global Appraisal of Individual Needs Short Screener (GAIN-SS) Substance Disorder Subscale (5-items) will be used to measure common psychological, behavioral, and personal problems related to alcohol and drug use. Each item is rated from 4 to 0 with 4, 3 and 2 representing use or problems in the past month, 2-3 months ago and 4-12 months ago, respectively. Items rated 1 represent problems over a year ago and items rated 0 indicate never having that problem. The subscale score is the total number of responses that indicate substance use problems within the last year. Substance Disorder Subscale scores for each arm are reported here. The min value is 0 and the max value is 5. Higher scores indicate worse outcomes (i.e., more severe problems related to substance use).

Time frame: 4 Week Follow-Up

ArmMeasureValue (MEAN)Dispersion
Welcome Basket Brief (WBbr)Global Appraisal of Individual Needs (GAIN) - Short Screener Substance Disorder Subscale1.20 Subscale scoreStandard Error 0.37
Welcome Basket (WB)Global Appraisal of Individual Needs (GAIN) - Short Screener Substance Disorder Subscale1.25 Subscale scoreStandard Error 0.31
Treatment As UsualGlobal Appraisal of Individual Needs (GAIN) - Short Screener Substance Disorder Subscale1.35 Subscale scoreStandard Error 0.99
Secondary

Global Appraisal of Individual Needs (GAIN) - Short Screener Substance Disorder Subscale

The 5-item Global Appraisal of Individual Needs Short Screener (GAIN-SS) Substance Disorder Subscale (5-items) will be used to measure common psychological, behavioral, and personal problems related to alcohol and drug use. Each item is rated from 4 to 0 with 4, 3 and 2 representing use or problems in the past month, 2-3 months ago and 4-12 months ago, respectively. Items rated 1 represent problems over a year ago and items rated 0 indicate never having that problem. The subscale score is the total number of responses that indicate substance use problems within the last year. Substance Disorder Subscale scores for each arm are reported here. The min value is 0 and the max value is 5. Higher scores indicate worse outcomes (i.e., more severe problems related to substance use).

Time frame: 6 Month Follow-Up

ArmMeasureValue (MEAN)Dispersion
Welcome Basket Brief (WBbr)Global Appraisal of Individual Needs (GAIN) - Short Screener Substance Disorder Subscale1.24 Subscale scoreStandard Error 0.44
Welcome Basket (WB)Global Appraisal of Individual Needs (GAIN) - Short Screener Substance Disorder Subscale1.31 Subscale scoreStandard Error 0.37
Treatment As UsualGlobal Appraisal of Individual Needs (GAIN) - Short Screener Substance Disorder Subscale1.51 Subscale scoreStandard Error 1.3
Secondary

Hospitalizations and Emergency Room Visits

The percentage of participants that were re-hospitalized or visited the emergency room during the study were captured through case manager report and verified through hospital electronic database if a CAMH hospitalization.

Time frame: Baseline to 6 Month Follow-Up

ArmMeasureGroupValue (NUMBER)
Welcome Basket Brief (WBbr)Hospitalizations and Emergency Room VisitsHospitalizations13.6 percentage of participants in arm
Welcome Basket Brief (WBbr)Hospitalizations and Emergency Room VisitsEmergency Room Visits13.6 percentage of participants in arm
Welcome Basket (WB)Hospitalizations and Emergency Room VisitsHospitalizations12.2 percentage of participants in arm
Welcome Basket (WB)Hospitalizations and Emergency Room VisitsEmergency Room Visits7.3 percentage of participants in arm
Treatment As UsualHospitalizations and Emergency Room VisitsHospitalizations6.8 percentage of participants in arm
Treatment As UsualHospitalizations and Emergency Room VisitsEmergency Room Visits9.1 percentage of participants in arm
Secondary

Personal Recovery Outcome Measure

The brief, 10-item version of the Personal Recovery Outcome Measure was used to assess change in recovery engagement. Total score is reported here. Total score is calculated by summing all the responses. Min total score value is 0 and max total score value is 40. Higher scores indicate better outcomes (i.e., more engagement in recovery).

Time frame: 6 Month Follow-Up

ArmMeasureValue (MEAN)Dispersion
Welcome Basket Brief (WBbr)Personal Recovery Outcome Measure6.61 Total ScoreStandard Error 0.49
Welcome Basket (WB)Personal Recovery Outcome Measure6.11 Total ScoreStandard Error 0.42
Treatment As UsualPersonal Recovery Outcome Measure6.22 Total ScoreStandard Error 1.5
Secondary

Personal Recovery Outcome Measure

The brief, 10-item version of the Personal Recovery Outcome Measure was used to assess change in recovery engagement. Total score is reported here. Total score is calculated by summing all the responses. Min total score value is 0 and max total score value is 40. Higher scores indicate better outcomes (i.e., more engagement in recovery).

Time frame: 4 Week Follow-Up

ArmMeasureValue (MEAN)Dispersion
Welcome Basket Brief (WBbr)Personal Recovery Outcome Measure6.09 Total ScoreStandard Error 0.44
Welcome Basket (WB)Personal Recovery Outcome Measure6.48 Total ScoreStandard Error 0.37
Treatment As UsualPersonal Recovery Outcome Measure6.29 Total ScoreStandard Error 1.5
Secondary

Personal Recovery Outcome Measure

The brief, 10-item version of the Personal Recovery Outcome Measure was used to assess change in recovery engagement. Total score is reported here. Total score is calculated by summing all the responses. Min total score value is 0 and max total score value is 40. Higher scores indicate better outcomes (i.e., more engagement in recovery).

Time frame: Baseline

ArmMeasureValue (MEAN)Dispersion
Welcome Basket Brief (WBbr)Personal Recovery Outcome Measure26.64 Total ScoreStandard Deviation 8.44
Welcome Basket (WB)Personal Recovery Outcome Measure24.20 Total ScoreStandard Deviation 7.97
Treatment As UsualPersonal Recovery Outcome Measure25.23 Total ScoreStandard Deviation 8.63
Secondary

Social Support Survey

Quality of Life will also be assessed using the Social Support Survey, a 19 item scale that measures emotional/information support, tangible support, affectionate support and positive social interaction. Overall support index (i.e., Total Score) is reported here and is calculated from averaging all items and then applying a transformation \[i.e., minimum possible score subtracted from observed score (first difference) and maximum possible score (second difference) and then the first difference divided by the second difference and that quotient multiplied by 100\] such that the min score is 0 and the max is 100. Higher scores indicate better outcomes (i.e., more frequent availability of different types of support).

Time frame: 4 Week Follow-Up

ArmMeasureValue (MEAN)Dispersion
Welcome Basket Brief (WBbr)Social Support Survey67.68 Total ScoreStandard Error 4.99
Welcome Basket (WB)Social Support Survey60.54 Total ScoreStandard Error 4.23
Treatment As UsualSocial Support Survey64.11 Total ScoreStandard Error 2.9
Secondary

Social Support Survey

Quality of Life will also be assessed using the Social Support Survey, a 19 item scale that measures emotional/information support, tangible support, affectionate support and positive social interaction. Overall support index (i.e., Total Score) is reported here and is calculated from averaging all items and then applying a transformation \[i.e., minimum possible score subtracted from observed score (first difference) and maximum possible score (second difference) and then the first difference divided by the second difference and that quotient multiplied by 100\] such that the min score is 0 and the max is 100. Higher scores indicate better outcomes (i.e., more frequent availability of different types of support).

Time frame: Baseline

ArmMeasureValue (MEAN)Dispersion
Welcome Basket Brief (WBbr)Social Support Survey65.59 Total ScoreStandard Deviation 20.69
Welcome Basket (WB)Social Support Survey64.07 Total ScoreStandard Deviation 21.85
Treatment As UsualSocial Support Survey57.44 Total ScoreStandard Deviation 18.58
Secondary

Social Support Survey

Quality of Life will also be assessed using the Social Support Survey, a 19 item scale that measures emotional/information support, tangible support, affectionate support and positive social interaction. Overall support index (i.e., Total Score) is reported here and is calculated from averaging all items and then applying a transformation \[i.e., minimum possible score subtracted from observed score (first difference) and maximum possible score (second difference) and then the first difference divided by the second difference and that quotient multiplied by 100\] such that the min score is 0 and the max is 100. Higher scores indicate better outcomes (i.e., more frequent availability of different types of support).

Time frame: 6 Month Follow-Up

ArmMeasureValue (MEAN)Dispersion
Welcome Basket Brief (WBbr)Social Support Survey68.66 Total ScoreStandard Error 6.24
Welcome Basket (WB)Social Support Survey63.54 Total ScoreStandard Error 5.41
Treatment As UsualSocial Support Survey67.50 Total ScoreStandard Error 3.9
Secondary

The Satisfaction With Life Scale

Quality of Life will be assessed with the Satisfaction With Life scale, an 18-item scale comprised of 4 subscales assessing living situation (4 items), social relationships (6 items), work (2 items), self and present life (6 items). Items are rated from 0 (not at all) to 1 (very little) to 2 (average or OK) to 3 (a lot) to 4 (a great deal). Subscale scores are reported here. The min value for all subscales is 0. The max value for the Living Situation subscale is 16. The max value for both the Social Relationships subscale and the Self and Present Life subscale is 24. The max value for the Work subscale is 8. Higher subscale scores indicate better outcomes (i.e., greater satisfaction with that area of life).

Time frame: 6 Month Follow-Up

ArmMeasureGroupValue (MEAN)Dispersion
Welcome Basket Brief (WBbr)The Satisfaction With Life ScaleLiving Situation Subscale2.66 Subscale scoreStandard Error 0.35
Welcome Basket Brief (WBbr)The Satisfaction With Life ScaleWork Subscale1.87 Subscale scoreStandard Error 0.34
Welcome Basket Brief (WBbr)The Satisfaction With Life ScaleSocial Relationships Subscale2.29 Subscale scoreStandard Error 0.33
Welcome Basket Brief (WBbr)The Satisfaction With Life ScaleSelf and Present Life Subscale2.45 Subscale scoreStandard Error 0.31
Welcome Basket (WB)The Satisfaction With Life ScaleLiving Situation Subscale2.67 Subscale scoreStandard Error 0.29
Welcome Basket (WB)The Satisfaction With Life ScaleSelf and Present Life Subscale2.22 Subscale scoreStandard Error 0.26
Welcome Basket (WB)The Satisfaction With Life ScaleWork Subscale1.71 Subscale scoreStandard Error 0.28
Welcome Basket (WB)The Satisfaction With Life ScaleSocial Relationships Subscale2.22 Subscale scoreStandard Error 0.27
Treatment As UsualThe Satisfaction With Life ScaleSelf and Present Life Subscale2.28 Subscale scoreStandard Error 0.05
Treatment As UsualThe Satisfaction With Life ScaleWork Subscale1.63 Subscale scoreStandard Error 0.15
Treatment As UsualThe Satisfaction With Life ScaleSocial Relationships Subscale1.97 Subscale scoreStandard Error 0.04
Treatment As UsualThe Satisfaction With Life ScaleLiving Situation Subscale2.23 Subscale scoreStandard Error 0.08
Secondary

The Satisfaction With Life Scale

Quality of Life will be assessed with the Satisfaction With Life scale, an 18-item scale comprised of 4 subscales assessing living situation (4 items), social relationships (6 items), work (2 items), self and present life (6 items). Items are rated from 0 (not at all) to 1 (very little) to 2 (average or OK) to 3 (a lot) to 4 (a great deal). Subscale scores are reported here. The min value for all subscales is 0. The max value for the Living Situation subscale is 16. The max value for both the Social Relationships subscale and the Self and Present Life subscale is 24. The max value for the Work subscale is 8. Higher subscale scores indicate better outcomes (i.e., greater satisfaction with that area of life).

Time frame: 4 Week Follow-Up

ArmMeasureGroupValue (MEAN)Dispersion
Welcome Basket Brief (WBbr)The Satisfaction With Life ScaleLiving Situation Subscale2.31 Subscale scoreStandard Error 0.3
Welcome Basket Brief (WBbr)The Satisfaction With Life ScaleSocial Relationships Subscale2.19 Subscale scoreStandard Error 0.28
Welcome Basket Brief (WBbr)The Satisfaction With Life ScaleWork Subscale1.94 Subscale scoreStandard Error 0.37
Welcome Basket Brief (WBbr)The Satisfaction With Life ScaleSelf and Present Life Subscale2.44 Subscale scoreStandard Error 0.27
Welcome Basket (WB)The Satisfaction With Life ScaleSelf and Present Life Subscale2.18 Subscale scoreStandard Error 0.22
Welcome Basket (WB)The Satisfaction With Life ScaleLiving Situation Subscale2.63 Subscale scoreStandard Error 0.24
Welcome Basket (WB)The Satisfaction With Life ScaleWork Subscale1.78 Subscale scoreStandard Error 0.3
Welcome Basket (WB)The Satisfaction With Life ScaleSocial Relationships Subscale2.14 Subscale scoreStandard Error 0.22
Treatment As UsualThe Satisfaction With Life ScaleSelf and Present Life Subscale2.36 Subscale scoreStandard Error 0.07
Treatment As UsualThe Satisfaction With Life ScaleSocial Relationships Subscale2.14 Subscale scoreStandard Error 0.15
Treatment As UsualThe Satisfaction With Life ScaleWork Subscale1.74 Subscale scoreStandard Error 0.14
Treatment As UsualThe Satisfaction With Life ScaleLiving Situation Subscale2.70 Subscale scoreStandard Error 0.02

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