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We The Village Family Support Study

SBIR Phase 1: Scalable Digital Delivery of Evidence-based Training for Family to Maximize Treatment Admission Rates of Opioid Use Disorder in Loved Ones-- We The Village Family Support Study

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04250077
Enrollment
45
Registered
2020-01-31
Start date
2020-01-09
Completion date
2020-06-30
Last updated
2026-04-16

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

Conditions

Community Reinforcement And Family Training, Family Health, Substance-Related Disorders

Brief summary

The United States is in the midst of an opioid crisis. Over-prescription of opioid analgesic pain relievers contributed to a rapid escalation of use and misuse of these substances across the country. In 2016, more than 2.6 million Americans were diagnosed with opioid use disorder (OUD) and more than 42,000 have died of overdose involving opioids. This death rate is more than any year on record and has quadrupled since 1999 (1,2). Leveraging the potential of available data bases and health IT technologies may help to combat opioid crisis by targeting various aspects of the problem ranging from the prevention of opioid misuse to OUD treatment. NIH through NIDA solicits the research and development of data-driven solutions and services that focus on issues related to opioid use prevention, opioid use, opioid overdose prevention or OUD treatment. In this project, We The Village, Inc. will address a need to prepare Concerned Significant Others (CSOs) to best use their influence over the trajectory of a loved one's OUD. CSOs are motivated to help, make majority of treatment decisions and payments and have influence over treatment entry and thus, impact the trajectory of an OUD. The project goal is to develop digital delivery of Community Reinforcement And Family Training (CRAFT) methodology, an empirical family behavioral intervention to improve outcomes around treatment entry, family functioning and substance use.

Detailed description

The primary objective of the proposed Phase I work is to determine the feasibility of delivering Community Reinforcement And Family Training (CRAFT) principles via scalable digital coaching methods and determine its efficacy based on measured outcomes. Technical Objectives 1. Modify the WTV platform to produce a CRAFT-informed automated prototype and protocol for live coaching. Technical Objectives 2. Test prototype usability and reliability to deliver the protocol, and make any refinements needed. Technical Objectives 3. Demonstrate prototype efficacy. Testing three digital scenarios: A. Automated CRAFT, B. CRAFT Coach, C. Peer support, the current WTV platform interaction. As a result, when tested at baseline versus post-intervention, CRAFT conditions (Coach and Automated) are expected to achieve better outcomes than the peer condition in a) treatment entry, b) Concerned Significant Others (CSO) health and wellbeing, c) CSO and identified patient relationship, d) CRAFT adeptness. Results will substantiate the case for Phase II roll out of the platform at scale, plus commercialization and dissemination through an existing and growing network of partners.

Interventions

BEHAVIORALCommunity Reinforcement And Family Training (CRAFT)

Community Reinforcement Approach and Family Training (CRAFT) is a scientifically based intervention designed to help concerned significant others (CSOs) to engage treatment-refusing substance abusers into treatment. This new intervention method was developed with the belief that the CSO can play a powerful role in helping to engage the substance user in treatment. It is often the substance user who reports that family pressure or influence is the reason sought treatment. CSOs benefit by becoming more independent and reducing their depression, anxiety and anger symptoms even if their loved one does not enter treatment. CRAFT uses a positive approach versus confrontation, emphasizing learning new skills to cope with old problems. Some components include: how to stay safe, outlining the context in which substance abusing behavior occurs, teaching CSOs how to use positive reinforcers (rewards) and how to let the substance user suffer the natural consequences for their using behavior.

An online peer support forum with other CSOs. Members of the forum post questions or comments to weekly peer-led discussions and receive responses and feedback from other CSO forum members. Members typically express concerns regarding their IP's wellbeing and ask other members to share any strategies they have employed when dealing with their IPs. Interactions typically, are based either in 12-Step strategies members have learned (usually through Al-Anon or Nar-Anon Family Groups or Family Training Workshops provided by treatment programs) or in CRAFT skills learned (usually from treatment programs or other We The Village members). A staff member from We The Village monitors forum interactions to ensure members are interacting respectfully.

Sponsors

We The Village, Inc.
Lead SponsorOTHER
Public Health Management Corporation
CollaboratorOTHER

Study design

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

Masking description

The participants will know what group they are in. When we send the data to the statistician for analysis we can code the groups (e.g., 123) and not tell them which is which. This masks (or blinds) him to the condition.

Intervention model description

Phase One of this project will develop and refine digital delivery of two modified CRAFT (Community Reinforcement and Family Training) interventions: automated and Group CRAFT protocol (CRAFT-A) and automated CRAFT protocol with live coaching (CRAFT-C) and assess the effectiveness of the adapted CRAFT protocols with WTV's business as usual model of Peer Support Forum (PEER). The goal of the project is to deliver an innovative and effective evidence-based behavioral intervention with consumer technology to an existing and growing online audience.

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Identify as a concerned significant other (CSO) of a loved one with an OUP * Be 19 years or older * No substance use disorder * Has concern about the opioid use of a loved one (IP) * Plans to be in close contact (phone/face-to-face) with the IP * The IP is not currently receiving treatment, or the IP is in treatment, but the CSO perceives the IP may benefit from additional treatment (e.g., receiving MAT but the IP may benefit from attending outpatient services, or in residential treatment, but will need to enter outpatient treatment upon discharge).

Exclusion criteria

* Does not agree to sign the consent form * Is not English-speaking * Is not able to understand the consent form * Does not have personal access to a smart phone with data or a computer with internet to be able to access the digital platform for the study conditions, quizzes, questionnaires, and follow-up communication * Reports that they have a drug abuse problem or a history of drug abuse or dependence and that they have not been in recovery for at least 2 years * Resides outside the United States

Design outcomes

Primary

MeasureTime frameDescription
Treatment Entry: IP Treatment Status3-month post studyParticipants reported whether their loved one had attended any treatment for their opioid problem since the last assessment by answering 8 questions regarding participation in treatment (e.g., detox, any treatment, new treatment, MAT, new MAT, counseling, support group, and other group). Reports of new treatment, new MAT, and treatment at the follow-up assessment which were not reported at baseline were categorized as treatment entry. In addition, entry into WTV recovery coaching, WTV family coaching, or reports of treatment entry to WTV staff were categorized as treatment entry. Outcome was the proportion of participants reporting that their loved one entered new treatment.

Secondary

MeasureTime frameDescription
Relationship Happiness: Relationship Happiness Scale3-month post studyGlobal score from the 10-item scale was calculated by adding scores (1-10) from 10 items. Minimum possible score was 10 and maximum was 100. Higher scores reflect greater Relationship Happiness.
CSO Health and Wellbeing: Profile of Mood State (POMS) - Short Form3-month post studyTotal mood disturbance (TMD) score calculated by adding scores (1-5) from the tension (6 items), depression (8 items), anger (7 items), fatigue (5 items), and confusion (5 items) subscales, then subtracting the score form the vigor (6 items) subscale. Minimum TMD possible score was 1 and maximum was 149. Higher scores reflect greater mood disturbance.
CSO Health and Wellbeing: SF-12 Physical Health Subscale3-month post studyThe 7-item scale was transformed so that is had a mean of 50 and a s.d. of 10 in the general US population. Scores above and below 50 are above and below the average with each point representing a difference of 1/10th of a standard deviation.
CSO Health and Wellbeing: SF-12 Mental Health Subscale3-month post studyThe 5-item scale was transformed so that is had a mean of 50 and a s.d. of 10 in the general US population. Scores above and below 50 are above and below the average with each point representing a difference of 1/10th of a standard deviation.
CSO Health and Wellbeing: SAS-SR Work Subscale3-month post studySocial Adjustment Scale, Self-Report. Standardized scale to assess individual's level of satisfaction in their role performance over the past two weeks key life areas. We used subscales representing the work, housework, and school areas of functioning. Each subscale consisted of 6 items scored on a 1-5 scale. A subscale adjustment score was obtained by summing the scores of all the items and dividing by the number of items actually answered. Thus, each subscale summary score had a minimum score of 1 and a maximum score of 5. Lower scores indicate higher satisfaction in their role performance.
CRAFT Knowledge: CRAFT Knowledge Scale3-month post studyKnowledge score calculated by adding the number of correct multiple-choice answers to 10 scenarios. Minimum score was 0 and maximum was 10. Higher scores reflect greater knowledge.
MAT3-month post studyParticipants reported whether their loved one had attended any treatment for their opioid problem since the last assessment by answering 8 questions regarding participation in treatment. Reports of new MAT and MAT at the follow-up assessment which was not reported at baseline were categorized as new MAT. In addition, reports of MAT entry to WTV staff were included. Outcome was the proportion of participants reporting that their loved one entered MAT. This differs from Outcome Measure 1 in that Outcome Measure 1 included drug-free and medication-assisted treatments of any type, while this measure included only MAT.

Countries

United States

Participant flow

Recruitment details

Recruitment began after IRB approval on January 8th 2020 and continued until 45 participants were enrolled on March 16th. Online recruitment: 1. Website callouts, emails, social media posts and 1:1 messages to WTV members. 2. Outreach to partners who provide services to patients with OUD. 3. Targeted digital and local advertising efforts.

Pre-assignment details

Not applicable, people were considered enrolled after baseline interview. 100% of those who completed baseline were assigned to one of the 3 conditions.

Participants by arm

ArmCount
CRAFT-A
Participants assigned to the CRAFT-A will have access to a 12-module on-line CRAFT intervention and asked to complete one module weekly for 12 weeks. Modules introduce CRAFT concepts and provide workbooks to assist participants in learning and applying the concepts. The modules include: 1)Introduction to CRAFT; 2) Communication Training; 3) Functional Analysis of Drug Using; 4) Positive Reinforcement; 5) Withdrawing Reinforcement; 6) Allowing Natural Consequences; 7) Problem-solving; 8) Life Enrichment; 9) Suggesting Treatment; 10) Recovery and Relapse; 11) Relationship; and 12) Recap of Skills. CRAFT-A participants also attend a weekly 60-minute online group sessions facilitated by a CRAFT-certified coach. During weekly group sessions concepts are briefly reviewed, questions are answered, and skills are practiced through role-plays of common situations.
15
CRAFT-C
Participants assigned to the CRAFT-C groups will have access to a 12-module on-line CRAFT intervention and asked to complete one module weekly for 12 weeks. Modules introduce CRAFT concepts and provide workbooks to assist participants in learning and applying the concepts. The modules include: 1) Introduction to CRAFT; 2) Communication Training; 3) Functional Analysis of Drug Using; 4) Positive Reinforcement; 5) Withdrawing Reinforcement; 6) Allowing Natural Consequences; 7) Problem-solving; 8) Life Enrichment; 9) Suggesting Treatment; 10) Recovery and Relapse; 11) Relationship; and 12) Recap of Skills. CRAFT-C participants attend a weekly 60-minute individualized on-on-one coaching session with a CRAFT certified coach. During weekly individual sessions concepts are briefly reviewed, questions are answered, and skills are practiced through role-plays of common situations. One-on-one sessions involve role-plays that are tailored to the participants' specific circumstances.
15
PEER
Participants assigned to the PEER group will participate in an online peer support forum with other CSOs. Members of the forum post questions or comments to weekly peer-led discussions and receive responses and feedback from other CSO forum members. Members typically express concerns regarding their IP's wellbeing and ask other members to share any strategies they have employed when dealing with their IPs. Interactions typically, are based either in 12-Step strategies members have learned (usually through Al-Anon or Nar-Anon Family Groups or Family Training Workshops provided by treatment programs) or in CRAFT skills learned (usually from treatment programs or other We The Village members). A staff member from We The Village monitors forum interactions to ensure members are interacting respectfully. This individual also will report any adverse or severe adverse events that members mention online.
15
Total45

Baseline characteristics

CharacteristicTotalPEERCRAFT-CCRAFT-A
Age, Continuous43.3 Years
STANDARD_DEVIATION 11.8
46.3 Years
STANDARD_DEVIATION 11.2
45.2 Years
STANDARD_DEVIATION 12.5
38.3 Years
STANDARD_DEVIATION 10.6
CRAFT Knowledge Scale4.1538461538461 units on a scale
STANDARD_DEVIATION 1.7250242033155
4.133333333 units on a scale
STANDARD_DEVIATION 1.552264091
4.090909091 units on a scale
STANDARD_DEVIATION 1.375103302
4.230769231 units on a scale
STANDARD_DEVIATION 2.241794153
Ethnicity (NIH/OMB)
Hispanic or Latino
2 Participants0 Participants0 Participants2 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
41 Participants15 Participants14 Participants12 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
2 Participants0 Participants1 Participants1 Participants
IP current treatment status for OUD
Don't know
2 Participants0 Participants0 Participants2 Participants
IP current treatment status for OUD
No
25 Participants9 Participants9 Participants7 Participants
IP current treatment status for OUD
Yes
18 Participants6 Participants6 Participants6 Participants
MAT Status17 Participants7 Participants4 Participants6 Participants
Profile of Mood State (POMS) - Short Form87.641025641025 units on a scale
STANDARD_DEVIATION 30.986828423742
79.6 units on a scale
STANDARD_DEVIATION 34.91990836
84.63636364 units on a scale
STANDARD_DEVIATION 29.26182745
99.46153846 units on a scale
STANDARD_DEVIATION 25.76695359
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
3 Participants1 Participants2 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
42 Participants14 Participants13 Participants15 Participants
Region of Enrollment
United States
45 participants15 participants15 participants15 participants
Relationship Happiness Scale28.789473684210 units on a scale
STANDARD_DEVIATION 16.309768080835
35.43 units on a scale
STANDARD_DEVIATION 19.62
23.45 units on a scale
STANDARD_DEVIATION 15.47
26.15 units on a scale
STANDARD_DEVIATION 10.9
SAS-SR10.92 units on a scale
STANDARD_DEVIATION 3.0402850743529
11.25 units on a scale
STANDARD_DEVIATION 2.815771906
10.2 units on a scale
STANDARD_DEVIATION 3.425395354
11.57142857 units on a scale
STANDARD_DEVIATION 2.935821456
Sex: Female, Male
Female
42 Participants13 Participants15 Participants14 Participants
Sex: Female, Male
Male
3 Participants2 Participants0 Participants1 Participants
SF-12 Mental Health Subscale33.223787948717 units on a scale
STANDARD_DEVIATION 5.8482705701241
33.94517267 units on a scale
STANDARD_DEVIATION 6.266345365
34.50071182 units on a scale
STANDARD_DEVIATION 6.312676025
31.31094692 units on a scale
STANDARD_DEVIATION 4.814387593
SF-12 Physical Health Subscale47.332612820512 units on a scale
STANDARD_DEVIATION 9.9462284409113
46.96861067 units on a scale
STANDARD_DEVIATION 12.19914184
46.73253 units on a scale
STANDARD_DEVIATION 10.49979736
48.26037769 units on a scale
STANDARD_DEVIATION 6.807966535

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 150 / 150 / 15
other
Total, other adverse events
0 / 150 / 150 / 15
serious
Total, serious adverse events
0 / 150 / 150 / 15

Outcome results

Primary

Treatment Entry: IP Treatment Status

Participants reported whether their loved one had attended any treatment for their opioid problem since the last assessment by answering 8 questions regarding participation in treatment (e.g., detox, any treatment, new treatment, MAT, new MAT, counseling, support group, and other group). Reports of new treatment, new MAT, and treatment at the follow-up assessment which were not reported at baseline were categorized as treatment entry. In addition, entry into WTV recovery coaching, WTV family coaching, or reports of treatment entry to WTV staff were categorized as treatment entry. Outcome was the proportion of participants reporting that their loved one entered new treatment.

Time frame: 3-month post study

Population: CRAFT-A: 13/15 final surveys collected, could not reach 2 of the participants. CRAFT-C: 11/15 final surveys collected, could not reach 3 of the participants, 1 participant removed themselves.~PEER: All participants completed final surveys.

ArmMeasureValue (NUMBER)
CRAFT-ATreatment Entry: IP Treatment Status10 count of participants
CRAFT-CTreatment Entry: IP Treatment Status8 count of participants
PEERTreatment Entry: IP Treatment Status6 count of participants
p-value: 0.0257818495% CI: [-0.0021812, 0.64531855]Agresti Caffo proportion comparison
Secondary

CRAFT Knowledge: CRAFT Knowledge Scale

Knowledge score calculated by adding the number of correct multiple-choice answers to 10 scenarios. Minimum score was 0 and maximum was 10. Higher scores reflect greater knowledge.

Time frame: 3-month post study

Population: CRAFT-A: 13/15 final surveys collected, could not reach 2 of the participants. CRAFT-C: 11/15 final surveys collected, could not reach 3 of the participants, 1 participant removed themselves.~PEER: 15/15 All participants completed final surveys.

ArmMeasureValue (MEAN)Dispersion
CRAFT-ACRAFT Knowledge: CRAFT Knowledge Scale1.692307692 units on a scaleStandard Deviation 0.4985185153
CRAFT-CCRAFT Knowledge: CRAFT Knowledge Scale1.454545455 units on a scaleStandard Deviation 0.8131156282
PEERCRAFT Knowledge: CRAFT Knowledge Scale0.4 units on a scaleStandard Deviation 0.6458659746
p-value: 0.0628364195% CI: [-0.3873203, 2.97193574]t-test, 1 sided
Secondary

CSO Health and Wellbeing: Profile of Mood State (POMS) - Short Form

Total mood disturbance (TMD) score calculated by adding scores (1-5) from the tension (6 items), depression (8 items), anger (7 items), fatigue (5 items), and confusion (5 items) subscales, then subtracting the score form the vigor (6 items) subscale. Minimum TMD possible score was 1 and maximum was 149. Higher scores reflect greater mood disturbance.

Time frame: 3-month post study

Population: CRAFT-A: 10/15 final surveys collected, could not reach 2 of the participants, 3 chose not to respond to this measure.~CRAFT-C: 10/15 final surveys collected, could not reach 3 of the participants, 1 participant removed themselves, 1 chose not to respond to this measure.~PEER: 12/15 All participants completed final surveys, 3 chose not to respond to this measure.

ArmMeasureValue (MEAN)Dispersion
CRAFT-ACSO Health and Wellbeing: Profile of Mood State (POMS) - Short Form-43.1 units on a scaleStandard Deviation 14.26218777
CRAFT-CCSO Health and Wellbeing: Profile of Mood State (POMS) - Short Form-28.8 units on a scaleStandard Deviation 11.44241622
PEERCSO Health and Wellbeing: Profile of Mood State (POMS) - Short Form-3.916666667 units on a scaleStandard Deviation 6.862787592
p-value: 0.0138710895% CI: [-73.356073, -5.0105927]t-test, 1 sided
Secondary

CSO Health and Wellbeing: SAS-SR Work Subscale

Social Adjustment Scale, Self-Report. Standardized scale to assess individual's level of satisfaction in their role performance over the past two weeks key life areas. We used subscales representing the work, housework, and school areas of functioning. Each subscale consisted of 6 items scored on a 1-5 scale. A subscale adjustment score was obtained by summing the scores of all the items and dividing by the number of items actually answered. Thus, each subscale summary score had a minimum score of 1 and a maximum score of 5. Lower scores indicate higher satisfaction in their role performance.

Time frame: 3-month post study

Population: CRAFT-A: 7/15 final surveys collected, could not reach 2 of the participants, 6 chose not to respond to this measure or it did not apply.~CRAFT-C: 8/15 final surveys collected, could not reach 3 of the participants, 1 participant removed themselves, 3 chose not to respond to this measure or it did not apply.~PEER: 9/15 All participants completed final surveys, 6 chose not to respond to this measure or it did not apply.

ArmMeasureValue (MEAN)Dispersion
CRAFT-ACSO Health and Wellbeing: SAS-SR Work Subscale0.5714285714 units on a scaleStandard Deviation 0.2020305089
CRAFT-CCSO Health and Wellbeing: SAS-SR Work Subscale-0.875 units on a scaleStandard Deviation 0.6105471785
PEERCSO Health and Wellbeing: SAS-SR Work Subscale0.2222222222 units on a scaleStandard Deviation 0.5211573066
p-value: 0.5787262395% CI: [-5.4078121, 4.55066924]t-test, 1 sided
Secondary

CSO Health and Wellbeing: SF-12 Mental Health Subscale

The 5-item scale was transformed so that is had a mean of 50 and a s.d. of 10 in the general US population. Scores above and below 50 are above and below the average with each point representing a difference of 1/10th of a standard deviation.

Time frame: 3-month post study

Population: CRAFT-A: 11/15 final surveys collected, could not reach 2 of the participants, 2 chose not to respond to this measure.~CRAFT-C: 10/15 final surveys collected, could not reach 3 of the participants, 1 participant removed themselves, 1 chose not to respond to this measure.~PEER: 12/15 All participants completed final surveys, 3 chose not to respond to this measure.

ArmMeasureValue (MEAN)Dispersion
CRAFT-ACSO Health and Wellbeing: SF-12 Mental Health Subscale0.23875 units on a scaleStandard Deviation 2.415675325
CRAFT-CCSO Health and Wellbeing: SF-12 Mental Health Subscale0.782613 units on a scaleStandard Deviation 2.49361256
PEERCSO Health and Wellbeing: SF-12 Mental Health Subscale-1.238238333 units on a scaleStandard Deviation 2.783141683
p-value: 0.3463329395% CI: [-6.1910435, 9.14502026]t-test, 1 sided
Secondary

CSO Health and Wellbeing: SF-12 Physical Health Subscale

The 7-item scale was transformed so that is had a mean of 50 and a s.d. of 10 in the general US population. Scores above and below 50 are above and below the average with each point representing a difference of 1/10th of a standard deviation.

Time frame: 3-month post study

Population: CRAFT-A: 11/15 final surveys collected, could not reach 2 of the participants, 2 chose not to respond to this measure.~CRAFT-C: 10/15 final surveys collected, could not reach 3 of the participants, 1 participant removed themselves, 2 chose not to respond to this measure.~PEER: 12/15 All participants completed final surveys, 3 chose not to respond to this measure.

ArmMeasureValue (MEAN)Dispersion
CRAFT-ACSO Health and Wellbeing: SF-12 Physical Health Subscale5.309448182 units on a scaleStandard Deviation 2.481191221
CRAFT-CCSO Health and Wellbeing: SF-12 Physical Health Subscale0.192893 units on a scaleStandard Deviation 3.195979184
PEERCSO Health and Wellbeing: SF-12 Physical Health Subscale-3.127840833 units on a scaleStandard Deviation 2.150194321
p-value: 0.0090811895% CI: [1.59437702, 15.280201]t-test, 1 sided
Secondary

MAT

Participants reported whether their loved one had attended any treatment for their opioid problem since the last assessment by answering 8 questions regarding participation in treatment. Reports of new MAT and MAT at the follow-up assessment which was not reported at baseline were categorized as new MAT. In addition, reports of MAT entry to WTV staff were included. Outcome was the proportion of participants reporting that their loved one entered MAT. This differs from Outcome Measure 1 in that Outcome Measure 1 included drug-free and medication-assisted treatments of any type, while this measure included only MAT.

Time frame: 3-month post study

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
CRAFT-AMAT5 Participants
CRAFT-CMAT3 Participants
PEERMAT4 Participants
p-value: 0.2642228195% CI: [-0.2233244, 0.43508919]Agresti Caffo proportion comparison
Secondary

Relationship Happiness: Relationship Happiness Scale

Global score from the 10-item scale was calculated by adding scores (1-10) from 10 items. Minimum possible score was 10 and maximum was 100. Higher scores reflect greater Relationship Happiness.

Time frame: 3-month post study

Population: CRAFT-A: 11/15 final surveys collected, could not reach 2 of the participants and 2 chose not to respond to this measure.~CRAFT-C: 10/15 final surveys collected, could not reach 3 of the participants, 1 participant removed themselves, and 1 chose not to respond to this measure.~PEER: 12/15 All participants completed final surveys but 3 chose not to respond to this measure.

ArmMeasureValue (MEAN)Dispersion
CRAFT-ARelationship Happiness: Relationship Happiness Scale21.54545455 units on a scaleStandard Deviation 4.993384053
CRAFT-CRelationship Happiness: Relationship Happiness Scale23.3 units on a scaleStandard Deviation 6.645048282
PEERRelationship Happiness: Relationship Happiness Scale1.5 units on a scaleStandard Deviation 5.761023688
p-value: 0.0078729795% CI: [4.18213496, 35.9087741]t-test, 1 sided

Source: ClinicalTrials.gov · Data processed: Apr 17, 2026