Family RelationshipNCT04273126
Helping Families Pilot of a Family Resilience Program for Families Experiencing Homelessness
A study testing Adapted Family Resilience Intervention in people with Family Relationship and Coping Skills, run by University of California, Los Angeles at 1 site in United States.
Trial summary
The goal of this study is to pilot an adapted family resilience program among families with a recent history of homelessness in Los Angeles County and to assess for feasibility and acceptability. Read more about this study
- Who is it for?
- Ages 8 years and olderHealthy volunteers can take part
- Conditions the study is for
- Family Relationship, Coping Skills
- What is being tested?
- Adapted Family Resilience Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Feb 2020to 3 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 8 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- English speaking
- Family has a history of homelessness within the past two years (homelessness defined by the Department of Health and Human Services definition)
- Parent/guardian/caregiver has custody of and cares for a youth between the ages of 8-17
- Both youth and parent/guardian/caregiver are able to take part in an 8 module session intervention
Who cannot join
- Does not meet inclusion criteria
- Has taken part in a Families OverComing Under Stress (FOCUS) intervention previously
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Strengthening Homeless Families
The goal of this study is to pilot an adapted family resilience program among families with a recent history of homelessness in Los Angeles County and to assess for feasibility and acceptability. The investigators have adapted a family resilience program called Families Overcoming Under Stress (FOCUS), a trauma-informed intervention designed for families experiencing trauma, parental substance use, and homelessness. Our primary hypothesis is that the adapted family resilience program will be feasible and acceptable to families with a recent history of homelessness. Families that are eligible to participate in the study will be assigned to the adapted family resilience intervention. The intervention program consists of around 8-10 modules lasting up to one hour each. The program provides psychoeducation and teaches resilience skills including communication, problem solving, goal setting, and how to deal with stress. Families will be asked to fill out 3 surveys (one at the beginning of the program, one at the end of the program, and at 6 months follow-up). Some families may also be asked to participate in a hour long interview after the completion of the program for feedback on the program.
At this time, all assessments and intervention are being conducted remotely due to the pandemic.
- Conditions
- Family Relationship, Coping Skills
- Being tested
- Adapted Family Resilience Intervention
- Keywords
- resilience, psychological, homelessness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adapted Family Resilience InterventionBehavioural
The program consists of approximately 8-10 modules lasting approximately one hour. Sessions focus on psychoeducation and key resilience skills.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | This arm consists of approximately 8-10 modules lasting approximately one hour and consisting of psychoeducation and core components including communication, problem solving, goal setting, and dealing with stress, tailored to families with experiences of homelessness and parental substance use. Receives: Behavioral: Adapted Family Resilience Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of the adapted family resilience intervention for families experiencing homelessness and parental SUDs through retention rates of participants.
Feasibility is defined as the extent to which the adapted intervention can be implemented with families with an experience of homelessness and parental SUDs, assessed through measuring rate of retention of participants.
Measured: 6 months
Feasibility of the adapted family resilience intervention for families experiencing homelessness and parental SUDs through completion of program core components.
Feasibility is defined as the extent to which the adapted intervention can be implemented with families with an experience of homelessness and parental SUDs, assessed through measuring number of program core components completed by participants.
Measured: 3 months
Acceptability of the adapted family resilience intervention to families experiencing homelessness and parental SUDs through qualitative interviews with youth and parents inquiring about intervention acceptability.
The investigators will assess acceptability of implementing the adapted intervention with families experiencing homelessness and parental SUDs by conducting qualitative interviews with a subset of parent and youth participants completing the intervention. The interviews will explore acceptability of the intervention to families experiencing homelessness and parental substance use disorders and recommendations for improvement. The interviews will be audio-recorded, transcribed, and analyzed using thematic content analysis.
Measured: 3 months
Acceptability of the adapted family resilience intervention through a self-report intervention acceptability measure.
Acceptability is defined as the perception that the adapted intervention is agreeable and satisfactory.The investigators will administer a self-report measure of the acceptability of core components of the intervention to be completed following the intervention by parents and youth, with higher score indicating greater acceptability of the intervention to families experiencing homelessness and parental SUDs. Each individual item is scaled with a range of 1 (low) to 5 (high).
Measured: 3 months
Secondary outcomes (21)
Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST)
Self reported measure administered to parents in the study to assess for substance use across lifetime and in the past 3 months. Each of the 8 item responses vary in scoring. The total substance involvement score (global continuum of risk) can be calculated by summing up the responses to all items. A higher score indicates higher risk for problems related to substance use.
Measured: Baseline, 3 month, 6 month
Addiction Severity Index (ASI)
Self reported measure administered to parents to assess for drug and alcohol use in the past 30 days and lifetime of regular use. The ASI does not yield a composite score but assesses days of use and extended periods of use.
Measured: Baseline, 3 month, 6 month
General Anxiety Disorder (GAD-7)
Self reported measure administered to parents to assess anxiety level. Each of the 7 item responses are scored from 0 (not at all) to 3 (nearly every day), yielding a total score ranging from 0-21. A higher score suggests higher level of anxiety.
Measured: Baseline, 3 month, 6 month
Patient Health Questionnaire (PHQ-9)
Self reported measure administered to parents to assess depression severity. Each of the 9 item responses are scored from 0 (not at all) to 3 (nearly every day), yielding a total score ranging from 0-27. A higher score suggests higher level of depression.
Measured: Baseline, 3 month, 6 month
PTSD Checklist for the DSM-V (Diagnostic and Statistical Manual)
Self-reported measure administered to parents that assesses the severity of PTSD symptoms over the past month. The PTSD Checklist for DSM-5 (PCL-5), the responses are scored from 0 (not at all) to 4 (extremely). To assess total symptom severity, scores for each of the 20 items are summed, the range is 0-80, with higher levels indicating higher severity.
Measured: Baseline, 3 month, 6 month
Short Form 12 (SF-12)
Self reported measure administered to parents to assess health and well-being. The SF-12 is scored as physical (PCS-12) and mental (MCS-12) component summary scales. The PCS-12 and MCS-12 scores use norm-based scoring with 50 being the population mean. The possible scores for PCS-12 and MCS-12 could range from 0 (worst) to 100 (best), with scores above and below 50 being above and below average.
Measured: Baseline, 3 month, 6 month
Connor-Davidson Resilience Scale (CD-RISC)
Self reported measure administered to parents to assess resilience. Each of the 10 item responses are scored from 0 (not true at all) to 4 (true nearly all of the time), yielding a total score that ranges from 0-40. A higher score indicates more resilience.
Measured: Baseline, 3 month, 6 month
Medical Outcomes Study Social Support Survey (MOS-SSS)
Self-reported measure administered to parents to assess social support. Each of the of 8 item responses are scored from 1 (none of the time) to 5 (all of the time), yielding a total score that ranges from 8-40. A higher score for an individual scale or for the overall support index indicates more support.
Measured: Baseline, 3 month, 6 month
Monitoring the Future Scale (Substance Use Scale)
Self reported measures to assess substance use in the past 30 days and lifetime for youth for each selected substance. For the 29 items, responses range from from "0 occasions of use" to "40 or more occasions of use."
Measured: Baseline, 3 month, 6 month
Monitoring the Future Scale (Perceived Risk Scale)
Self reported measure to assess perceived risks of substance use for youth for each selected substance. For the 6 items, each response ranges from "no risk" to "great risk", with the option to select "can't say, drug unfamiliar."
Measured: Baseline, 3 month, 6 month
Monitoring the Future Scale (Disapproval Scale)
Self reported measure to assess disapproval of substance use for youth. For each of the 17 items, responses range from "not disapprove" to "strongly disapprove."
Measured: Baseline, 3 month, 6 month
Strength and Difficulties Questionnaire (SDQ)
Self reported measure to assess psychological strengths and difficulties of children/youth. Parents will complete the measure for their children. The measure will also be delivered to youth (age 11-14). Each of the 25 item responses are scored from 0 (not true) to 2 (certainly true). The items are divided into 5 subscales (emotional problems, conduct problems, hyperactivity, peer problems, and prosocial). The first four subscales refer to difficulties that children may have and may be group together in a general subscale of difficulties (20 items). The subscale of prosocial skills refer to positive and adaptive behaviors. For each of the 5 subscales, the score can range from 0-10. The score of the difficulties subscale ranges from 0 to 40. Higher scores suggest higher emotional and behavioral symptoms.
Measured: Baseline, 3 month, 6 month
Screen for Child Anxiety Related Emotional Disorders (SCARED)
Self reported measure to assess childhood anxiety disorders, including panic, generalized anxiety, separation anxiety, social phobia, and school phobia among children . Each of the 41 item responses are scored from 0 (not true or hardly ever true) to 2 (very true or often true), yielding a total score ranging from 0-82.
Measured: Baseline, 3 month, 6 month
Mood and Feelings Questionnaire (MFQ)
Self reported measure to assess depression in children and youth. Each of the 13 item responses are scored from 0 (not true) to 2 (true), yielding a total score ranging from 0-26. A higher score suggests more severe depressive symptoms.
Measured: Baseline, 3 month, 6 month
Resistance to Peer Influence Scale
Self reported measure to assess resistance to peer influence for youth.The measure presents respondents with a series of 10 pairs of statements and asks them to choose the statement that is the best descriptor. After indicating the best descriptor, the respondent is then asked whether the description is "Really True" or "Sort of True." Responses are then coded on a 4-point scale, ranging from "Really true" for one descriptor to "Really true" for the other descriptor, and averaged. A higher score suggests greater resistance to peer influence.
Measured: Baseline, 3 month, 6 month
Children's Coping Strategies Checklist-Revision 1 (CCSC-R1)
Self reported measure to assess coping strategies among youth. Each of the 54 item responses are scored from 1 (never) to 4 (always). Scoring for the four major factors of coping is reached by taking the mean.
Measured: Baseline, 3 month, 6 month
Resilience Youth Development Module (RYDM) of the California Healthy Kids Survey (CHKS)
Self reported measure to assess internal assets for children and youth. Each of the 12 item responses are scored from 1 (not at all true) to 4 (very much true), yielding a score that ranges from 12 to 48. A higher score indicates higher levels of internal assets.
Measured: Baseline, 3 month, 6 month
Deviant Peer Affiliation Scale
Self reported measure to assess deviant peer affiliations for youth (age 12-14). Each of the 3 item responses are scored from 1 (very few) to 5 (almost all), with the exception of one reverse-coded item. The total score is computed by averaging across all items. A higher score suggests greater deviant peer affiliations.
Measured: Baseline, 3 month, 6 month
McMaster Family Assessment Device (FAD)
Self reported measure to assess family functioning for parents and youth over 12. Each of the 12 item responses are scored from 1 (strongly agree) to 4 (strongly disagree). The scores are added up and then divided by the number of items, giving a total score ranging from 1 to 4. A higher score indicates worse functioning.
Measured: Baseline, 3 month, 6 month
Parental Sense of Competence Scale (PSOC)
Self reported measure for parents to assess parenting self-esteem. Each of the 17 item responses are scored from 1 (strongly disagree) to 6 (strongly agree), yielding a total score that ranges from 17-102. A higher score suggests greater self-esteem.
Measured: Baseline, 3 month, 6 month
Parental Monitoring Scale
Self reported measure to assess adolescents' perception of their parents' monitoring. Each of the 6 item responses are scored from 1 (never) to 5 (always). A composite score is obtained by averaging responses to the 6 items. A higher score indicates higher perceived perception of parent monitoring. This scale is also delivered to parents, in order to assess the parent's perception of their supervision. A composite scale score is obtained in the same manner. Higher score indicates higher perceived perception of their monitoring.
Measured: Baseline, 3 month, 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start19 Feb 2020
- Primary completion3 Apr 2023
- Study completion3 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Family RelationshipStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), American Academy of Child Adolescent Psychiatry.
- Responsible party
- Principal investigator, Roya Ijadi-Maghsoodi, MD, MSHPM, University of California, Los Angeles
- Investigators
- Roya Ijadi-Maghsoodi, MD, MSHPM, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04273126
- Sponsor's protocol ID
- K12DA000357
- Other IDs
- K12DA000357
- Status last verified
- Jun 2024
- First submitted
- 22 Jan 2020
- Last updated
- 12 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strengthening Homeless Families
- ClinicalTrials.gov ID
- NCT04273126
- Acronym / sponsor ID
- K12DA000357
- Conditions
- Family Relationship, Coping Skills
- Keywords
- resilience, psychological, homelessness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), American Academy of Child Adolescent Psychiatry.
- Study start
- 19 Feb 2020 (actual)
- Primary completion
- 3 Apr 2023 (actual)
- Study completion
- 3 Apr 2023 (actual)
- First posted
- 17 Feb 2020 (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 goal of this study is to pilot an adapted family resilience program among families with a recent history of homelessness in Los Angeles County and to assess for feasibility and acceptability. The investigators have adapted a family resilience program called Families Overcoming Under Stress (FOCUS), a trauma-informed intervention designed for families experiencing trauma, parental substance use, and homelessness. Our primary hypothesis is that the adapted family resilience program will be feasible and acceptable to families with a recent history of homelessness. Families that are eligible to participate in the study will be assigned to the adapted family resilience intervention. The intervention program consists of around 8-10 modules lasting up to one hour each. The program provides psychoeducation and teaches resilience skills including communication, problem solving, goal setting, and how to deal with stress. Families will be asked to fill out 3 surveys (one at the beginning of the program, one at the end of the program, and at 6 months follow-up). Some families may also be asked to participate in a hour long interview after the completion of the program for feedback on the program.
At this time, all assessments and intervention are being conducted remotely due to the pandemic.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Adapted Family Resilience InterventionThis arm consists of approximately 8-10 modules lasting approximately one hour and consisting of psychoeducation and core components including communication, problem solving, goal setting, and dealing with stress, tailored to families with experiences of homelessness and parental substance use. |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- English speaking
- Family has a history of homelessness within the past two years (homelessness defined by the Department of Health and Human Services definition)
- Parent/guardian/caregiver has custody of and cares for a youth between the ages of 8-17
- Both youth and parent/guardian/caregiver are able to take part in an 8 module session intervention
Key exclusion criteria (2 listed)
- Does not meet inclusion criteria
- Has taken part in a Families OverComing Under Stress (FOCUS) intervention previously
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 |
|---|---|---|
| Adapted Family Resilience InterventionThe program consists of approximately 8-10 modules lasting approximately one hour. Sessions focus on psychoeducation and key resilience skills. | Behavioural | Intervention |
Primary outcome
Feasibility of the adapted family resilience intervention for families experiencing homelessness and parental SUDs through retention rates of participants.
Time frame: 6 months
Feasibility is defined as the extent to which the adapted intervention can be implemented with families with an experience of homelessness and parental SUDs, assessed through measuring rate of retention of participants.
Feasibility of the adapted family resilience intervention for families experiencing homelessness and parental SUDs through completion of program core components.
Time frame: 3 months
Feasibility is defined as the extent to which the adapted intervention can be implemented with families with an experience of homelessness and parental SUDs, assessed through measuring number of program core components completed by participants.
Acceptability of the adapted family resilience intervention to families experiencing homelessness and parental SUDs through qualitative interviews with youth and parents inquiring about intervention acceptability.
Time frame: 3 months
The investigators will assess acceptability of implementing the adapted intervention with families experiencing homelessness and parental SUDs by conducting qualitative interviews with a subset of parent and youth participants completing the intervention. The interviews will explore acceptability of the intervention to families experiencing homelessness and parental substance use disorders and recommendations for improvement. The interviews will be audio-recorded, transcribed, and analyzed using thematic content analysis.
Acceptability of the adapted family resilience intervention through a self-report intervention acceptability measure.
Time frame: 3 months
Acceptability is defined as the perception that the adapted intervention is agreeable and satisfactory.The investigators will administer a self-report measure of the acceptability of core components of the intervention to be completed following the intervention by parents and youth, with higher score indicating greater acceptability of the intervention to families experiencing homelessness and parental SUDs. Each individual item is scaled with a range of 1 (low) to 5 (high).
21 secondary outcomes
Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST)
Time frame: Baseline, 3 month, 6 month
Addiction Severity Index (ASI)
Time frame: Baseline, 3 month, 6 month
General Anxiety Disorder (GAD-7)
Time frame: Baseline, 3 month, 6 month
Patient Health Questionnaire (PHQ-9)
Time frame: Baseline, 3 month, 6 month
PTSD Checklist for the DSM-V (Diagnostic and Statistical Manual)
Time frame: Baseline, 3 month, 6 month
Short Form 12 (SF-12)
Time frame: Baseline, 3 month, 6 month
Connor-Davidson Resilience Scale (CD-RISC)
Time frame: Baseline, 3 month, 6 month
Medical Outcomes Study Social Support Survey (MOS-SSS)
Time frame: Baseline, 3 month, 6 month
Monitoring the Future Scale (Substance Use Scale)
Time frame: Baseline, 3 month, 6 month
Monitoring the Future Scale (Perceived Risk Scale)
Time frame: Baseline, 3 month, 6 month
Monitoring the Future Scale (Disapproval Scale)
Time frame: Baseline, 3 month, 6 month
Strength and Difficulties Questionnaire (SDQ)
Time frame: Baseline, 3 month, 6 month
Screen for Child Anxiety Related Emotional Disorders (SCARED)
Time frame: Baseline, 3 month, 6 month
Mood and Feelings Questionnaire (MFQ)
Time frame: Baseline, 3 month, 6 month
Resistance to Peer Influence Scale
Time frame: Baseline, 3 month, 6 month
Children's Coping Strategies Checklist-Revision 1 (CCSC-R1)
Time frame: Baseline, 3 month, 6 month
Resilience Youth Development Module (RYDM) of the California Healthy Kids Survey (CHKS)
Time frame: Baseline, 3 month, 6 month
Deviant Peer Affiliation Scale
Time frame: Baseline, 3 month, 6 month
McMaster Family Assessment Device (FAD)
Time frame: Baseline, 3 month, 6 month
Parental Sense of Competence Scale (PSOC)
Time frame: Baseline, 3 month, 6 month
Parental Monitoring Scale
Time frame: Baseline, 3 month, 6 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2024.
- Individual participant dataSharing planned: No
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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.
Roya Ijadi-Maghsoodi, MD, MSHPM principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adapted Family Resilience Intervention in people with Family Relationship and Coping Skills, run by University of California, Los Angeles 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 4 inclusion and 2 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: finished, as of the sponsor's last update on 12 Jun 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Feasibility of the adapted family resilience intervention for families experiencing homelessness and parental SUDs through retention rates of participants. (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2024.