Family MembersNCT06565429
Feasibility of the 5-Step Method in the U.S.
A study testing 5-Step Method Intervention in people with Family Members and Relatives, run by Villanova University at 1 site in United States.
Trial summary
The purpose of this study is to see if it is possible (feasible) to introduce a behavioral intervention for family members affected by a relative's misuse of drugs and/or alcohol in the United States. The intervention is called the 5-Step Method. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Family Members, Relatives, Substance-Related Disorders
- What is being tested?
- 5-Step Method Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2024to 6 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- -if person states the relative with alcohol and/or drug misuse has been physically violent towards the potential participant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Feasibility Study of Delivery of the 5-Step Method Intervention for Family Members of Persons With Substance Use Disorder in the United States
The purpose of this study is to see if it is possible (feasible) to introduce a behavioral intervention for family members affected by a relative's misuse of drugs and/or alcohol in the United States. The intervention is called the 5-Step Method. It will be a randomized control trial, with a total of 24 participants, and 12 in each group. The study lasts for approximately 12 weeks for the participant. The intervention group will receive a self-help handbook of the 5-Step Method, and the control group will not. Although the control group will not receive an intervention from the research team, they are allowed to look for and use any currently available program for affected family members (for example, Al-Anon, or Nar-Anon) during the study period. The study is being done because the 5-Step Method has not been used or evaluated in the U.S. (or the creators are unaware that it is in use here). There are two aims (objectives): (1) to see if it is feasible to introduce the 5-Step Method into the U.S.; (2) to look at trends in the baseline and followup survey scores to see if there is evidence of preliminary participant response.
Read the detailed description
The study will be implemented in the United States using online contacts via Zoom and email. A participant in the study will be an affected family member of someone with drug and/or alcohol misuse who has been experiencing stress as a result of the substance misuse for at least the past six months. Both stress and their relative's misuse will be self-identified by the participant. A participant will reside in the United States of America. Recruitment for the study will include advertisements via social media, newspaper notices, and flyers posted at stores and healthcare sites. Once potential participants have contacted the PI and have been screened, consented, and have completed the baseline survey, they will be randomized into either the intervention group or the control group. Once randomized the participant and PI will no longer be blinded to the treatment condition. Those in the intervention group will receive the self-help handbook via the U.S. mail. The control group does not receive an intervention, but could use currently available programs if desired, although information about these programs will not be provided by the PI. All participants will receive emails at regular intervals during their 12-week study period. Because the intervention is completed at the individual level, study recruitment will occur on a rolling basis until 24 participants have been enrolled. Data regarding the feasibility of the study (recruitment, retention, refusal rates, etc.) will be collected. Baseline and follow up surveys will be compared for evidence of participant response.
- Conditions
- Family Members, Relatives, Substance-Related Disorders, Alcohol-Related Disorders, Coping Skills, Stress, Psychological
- Being tested
- 5-Step Method Intervention
- Keywords
- Social Support
- Medical subject headings
- Substance-Related Disorders, Alcohol-Related Disorders, Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5-Step Method InterventionBehavioural
The 5-Step Method (5SM) intervention is delivered through a self-help handbook: There are writing prompts for the affected family member (AFM) in each step. The steps end with a summary, a space to reflect and a statement that the step is complete but can be reviewed as needed. The steps are: 1.Explore how the relative's drug and/or alcohol misuse is affecting the family member, causing stress and strain. 2.Determine the information the AFM needs to understand the situation using evidence-based websites in the handbook. 3.Reflect on coping styles, and which ones might be useful. 4.Determine who is a source of positive social support, and who could be one that the AFM has not used yet. 5.Review steps 1-4 and determine if the AFM is feeling less stress and strain, or if more help is needed and use websites to look for additional help. The activities should take about 1 hour per week.
| Study group | Role | What they receive |
|---|---|---|
| 5-Step Method Intervention Group | Experimental | Receives the 5-Step Method intervention self-help handbook and emails every two weeks to encourage continued use Receives: Behavioral: 5-Step Method Intervention |
| Control Group | No intervention | Standard of care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability
Scores on Acceptability of Intervention Measure (Weiner et al., 2017), a validated and standardized instrument combined with eight other acceptability questions specific to the 5-Step Method Handbook.
Measured: One year post completing the intervention
Study process rates
Study process rates will be assessed by quantitatively tracking the recruitment rate, retention rate, refusal rate, eligibility rate, and study completion rate.
Measured: One year post completing the intervention. Rates will be tallied at the end of the study
Likelihood of adverse events
Safety will be assessed for all participants by quantitatively summarizing the number of adverse events that are considered to be unexpected, serious, and/or possibly or definitely related to the study
Measured: One year post completing the intervention
Resources
How much time all individual participants spent filling out the surveys, assessed via a survey
Measured: One year post completing the intervention
Adherence to treatment protocol
The adherence to treatment protocol will be assessed by asking the intervention group questions about how they interacted with the self-help handbook to determine if they used the handbook as designed or if they used it in some other way.
Measured: 12 weeks after starting study, if placed in the intervention group
Marketing
Marketing of the study will be assessed by asking those who inquire about the study where they learned about the study to determine which locations may be better for recruitment in future studies.
Measured: One year post completing the intervention. Will review responses and tally results
Ease of use
Ease of use of the study will be assessed by asking participants two questions at the end of the follow-up survey about the way the surveys were worded. The answers of these questions will be reviewed and tallied as well as qualitatively described. The surveys of the study are validated tools, and the only allowed changes to the survey questions were to change from UK English to US English on spelling alone (behaviour to behavior for example). Syntax and word choice were not allowed to be changed. It is possible that how the phrases are stated and the words used will not be as easy to read for an American as compared to someone from the UK, where the intervention was created. The two questions ask if there were any difficulties understanding the survey, and if so, did they think this may have affected how they answered any of the questions.
Measured: One year post completing the intervention
Secondary outcomes (4)
Stress
Family Member Impact Questionnaire (FMI) Scores range from 0-48, with higher scores indicating higher stress.
Measured: Baseline and change over 12 week period
Coping
Symptom Rating Test (SRT) Scores range from 0-90. There are three subscales of coping, with higher scores on two subscales generally associated with higher scores on stress and strain. One subscale is generally associated with lower scores on stress and strain.
Measured: Baseline and change over 12 week period
Strain
Coping Questionnaire (CQ) Scores range from 0-60, higher scores indicating higher scores higher strain.
Measured: Baseline and change over 12 week period
Social Support
Alcohol, Drugs, and the Family Social Support Scale (ADF-SSS) Scores range from 0-75 for the total score. Two subscales with higher scores show improved social support, while the third subscale should have lower numbers when there is an improvement.
Measured: Baseline and change over 12 week period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2024
- Study start1 Sep 2024
- Primary completion6 Aug 2026 (estimated)
- Study completion6 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Family MembersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Villanova University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Therese M Collins, MS, RN, Principal investigator, Villanova UniversityHelene Moriarty, PhD, RN, FAAN, Principal investigator, Villanova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06565429
- Sponsor's protocol ID
- IRB-FY2024-145
- Status last verified
- Sep 2025
- First submitted
- 16 Aug 2024
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only aggregated participant data is planned to be shared
Publications
Copello A, Templeton L, Orford J, Velleman R, Patel A, Moore L, MacLeod J, Godfrey C. The relative efficacy of two levels of a primary care intervention for family members affected by the addiction problem of a close relative: a randomized trial. Addiction. 2009 Jan;104(1):49-58. doi: 10.1111/j.1360-0443.2008.02417.x.
PubMed 19133888Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3.
PubMed 28851459Velleman, R., Orford, J., Templeton, L., Copello, A., Patel, A., Moore, L., Macleod, J., & Godfrey, C. (2011). 12-month follow-up after brief interventions in primary care for family members affected by the substance misuse problem of a close relative. Addiction Research & Theory, 19(4), 362-374. https://doi.org/10.3109/16066359.2011.564691
Orford, J., Templeton, L., Patel, A., Copello, A., & Velleman, R. (2007a). The 5-step family intervention in primary care: I. strengths and limitations according to family members. Drugs: Education, Prevention and Policy, 14(1), 29-47. https://doi.org/10.1080/09687630600997451
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study of Delivery of the 5-Step Method Intervention for Family Members of Persons With Substance Use Disorder in the United States
- ClinicalTrials.gov ID
- NCT06565429
- Acronym / sponsor ID
- IRB-FY2024-145
- Conditions
- Family Members, Relatives, Substance-Related Disorders, Alcohol-Related Disorders, Coping Skills, Stress, Psychological
- Keywords
- Social Support
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Villanova UniversityUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 6 Aug 2026 (estimated)
- Study completion
- 6 Aug 2026 (estimated)
- First posted
- 22 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to see if it is possible (feasible) to introduce a behavioral intervention for family members affected by a relative's misuse of drugs and/or alcohol in the United States. The intervention is called the 5-Step Method. It will be a randomized control trial, with a total of 24 participants, and 12 in each group. The study lasts for approximately 12 weeks for the participant. The intervention group will receive a self-help handbook of the 5-Step Method, and the control group will not. Although the control group will not receive an intervention from the research team, they are allowed to look for and use any currently available program for affected family members (for example, Al-Anon, or Nar-Anon) during the study period. The study is being done because the 5-Step Method has not been used or evaluated in the U.S. (or the creators are unaware that it is in use here). There are two aims (objectives): (1) to see if it is feasible to introduce the 5-Step Method into the U.S.; (2) to look at trends in the baseline and followup survey scores to see if there is evidence of preliminary participant response.
Detailed description
The study will be implemented in the United States using online contacts via Zoom and email. A participant in the study will be an affected family member of someone with drug and/or alcohol misuse who has been experiencing stress as a result of the substance misuse for at least the past six months. Both stress and their relative's misuse will be self-identified by the participant. A participant will reside in the United States of America. Recruitment for the study will include advertisements via social media, newspaper notices, and flyers posted at stores and healthcare sites. Once potential participants have contacted the PI and have been screened, consented, and have completed the baseline survey, they will be randomized into either the intervention group or the control group. Once randomized the participant and PI will no longer be blinded to the treatment condition. Those in the intervention group will receive the self-help handbook via the U.S. mail. The control group does not receive an intervention, but could use currently available programs if desired, although information about these programs will not be provided by the PI. All participants will receive emails at regular intervals during their 12-week study period. Because the intervention is completed at the individual level, study recruitment will occur on a rolling basis until 24 participants have been enrolled. Data regarding the feasibility of the study (recruitment, retention, refusal rates, etc.) will be collected. Baseline and follow up surveys will be compared for evidence of participant response.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 5-Step Method Intervention Group | Experimental | Behavioral: 5-Step Method InterventionReceives the 5-Step Method intervention self-help handbook and emails every two weeks to encourage continued use |
| Control Group | No intervention | –Standard of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -if person states the relative with alcohol and/or drug misuse has been physically violent towards the potential participant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 5-Step Method InterventionThe 5-Step Method (5SM) intervention is delivered through a self-help handbook: There are writing prompts for the affected family member (AFM) in each step. The steps end with a summary, a space to reflect and a statement that the step is complete but can be reviewed as needed. The steps are: 1.Explore how the relative's drug and/or alcohol misuse is affecting the family member, causing stress and strain. 2.Determine the information the AFM needs to understand the situation using evidence-based websites in the handbook. 3.Reflect on coping styles, and which ones might be useful. 4.Determine who is a source of positive social support, and who could be one that the AFM has not used yet. 5.Review steps 1-4 and determine if the AFM is feeling less stress and strain, or if more help is needed and use websites to look for additional help. The activities should take about 1 hour per week. | Behavioural | 5-Step Method Intervention Group |
Primary outcome
Acceptability
Time frame: One year post completing the intervention
Scores on Acceptability of Intervention Measure (Weiner et al., 2017), a validated and standardized instrument combined with eight other acceptability questions specific to the 5-Step Method Handbook.
Study process rates
Time frame: One year post completing the intervention. Rates will be tallied at the end of the study
Study process rates will be assessed by quantitatively tracking the recruitment rate, retention rate, refusal rate, eligibility rate, and study completion rate.
Likelihood of adverse events
Time frame: One year post completing the intervention
Safety will be assessed for all participants by quantitatively summarizing the number of adverse events that are considered to be unexpected, serious, and/or possibly or definitely related to the study
Resources
Time frame: One year post completing the intervention
How much time all individual participants spent filling out the surveys, assessed via a survey
Adherence to treatment protocol
Time frame: 12 weeks after starting study, if placed in the intervention group
The adherence to treatment protocol will be assessed by asking the intervention group questions about how they interacted with the self-help handbook to determine if they used the handbook as designed or if they used it in some other way.
Marketing
Time frame: One year post completing the intervention. Will review responses and tally results
Marketing of the study will be assessed by asking those who inquire about the study where they learned about the study to determine which locations may be better for recruitment in future studies.
Ease of use
Time frame: One year post completing the intervention
Ease of use of the study will be assessed by asking participants two questions at the end of the follow-up survey about the way the surveys were worded. The answers of these questions will be reviewed and tallied as well as qualitatively described. The surveys of the study are validated tools, and the only allowed changes to the survey questions were to change from UK English to US English on spelling alone (behaviour to behavior for example). Syntax and word choice were not allowed to be changed. It is possible that how the phrases are stated and the words used will not be as easy to read for an American as compared to someone from the UK, where the intervention was created. The two questions ask if there were any difficulties understanding the survey, and if so, did they think this may have affected how they answered any of the questions.
4 secondary outcomes
Stress
Time frame: Baseline and change over 12 week period
Coping
Time frame: Baseline and change over 12 week period
Strain
Time frame: Baseline and change over 12 week period
Social Support
Time frame: Baseline and change over 12 week period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Background: PubMed 19133888Copello A, Templeton L, Orford J, Velleman R, Patel A, Moore L, MacLeod J, Godfrey C. The relative efficacy of two levels of a primary care intervention for family members affected by the addiction problem of a close relative: a randomized trial. Addiction. 2009 Jan;104(1):49-58. doi: 10.1111/j.1360-0443.2008.02417.x.
- Background: PubMed 28851459Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3.
- BackgroundVelleman, R., Orford, J., Templeton, L., Copello, A., Patel, A., Moore, L., Macleod, J., & Godfrey, C. (2011). 12-month follow-up after brief interventions in primary care for family members affected by the substance misuse problem of a close relative. Addiction Research & Theory, 19(4), 362-374. https://doi.org/10.3109/16066359.2011.564691
- BackgroundOrford, J., Templeton, L., Patel, A., Copello, A., & Velleman, R. (2007a). The 5-step family intervention in primary care: I. strengths and limitations according to family members. Drugs: Education, Prevention and Policy, 14(1), 29-47. https://doi.org/10.1080/09687630600997451
- Individual participant dataSharing planned: No. Only aggregated participant data is planned to be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Therese M Collins, MS, RN principal investigator
Villanova University
Helene Moriarty, PhD, RN, FAAN principal investigator
Villanova University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 5-Step Method Intervention in people with Family Members and Relatives, run by Villanova University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability (time frame: One year post completing the intervention). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06565429, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.