Self HarmNCT03709472

Computer Assisted Family Intervention to Treat Self-Harm Disparities in Latinas and Sexual/Gender Minority Youth

A study testing Computer Assisted CIFFTA and Behavioral: Traditional face-to-face treatment-no technology in people with Self Harm and Depression, run by University of Miami at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study is designed to refine and test the efficacy of a computer assisted culturally informed and flexible/adaptive intervention for Latino adolescents for whom self-harm behaviors are a health disparity-specifically, Latinas and sexual/gender minority youth. Read more about this study

Who is it for?: Ages 11 to 18 yearsHealthy volunteers can take part
Conditions the study is for: Self Harm, Depression, Emotion Dysregulation
What is being tested?: Computer Assisted CIFFTA and Behavioral: Traditional face-to-face treatment-no technology
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 172 participants
Where: 1 siteUnited States
Study dates: 12 Nov 2018to 23 Aug 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 11 to 18 years
All sexes
Healthy volunteers accepted
Child, Adult

Who may be able to join

be 11 to 18 years old;
self-report an act of self-harm in the past 6 months,
meet criteria for cut-off on two of the four underlying/maintaining factors (depression, emotion dysregulation, family conflict, substance use), and
live with at least one parent-figure who agrees to participate in assessments and treatment Participants should be willing and able to participate fully in the protocol (e.g., to accept assignment to either condition, to provide sufficient locator information for follow-up, to allow their treatment sessions to be recorded for fidelity/process assessment and supervision).

Who cannot join

have a history of DSM V Developmental Disorders, Elective Mutism, Organic Mental Disorders, Schizophrenia, Delusional Disorder, Psychotic Disorder, and Bipolar Affective Disorder.
are actively in crisis and reporting current ideation with a specific plan and with means to complete the plan.

Trial locations and contacts

1 site in 1 country.

United States1 site

Institute for Individual and Family Counseling
Coral Gables, Florida, 33146

Other trials in United States

About this study

Official title: Computer Assisted Family Intervention to Treat Self- Harm Disparities in Latinas and Sexual/Gender Minority Youth (CA CIFFTA)

Read the detailed description

This study enhances an original Computer Assisted Culturally Informed and Flexible Family-Based Treatment for Adolescents (CA CIFFTA) to directly address key targets related to self-harm behavior (e.g., depression, emotion dysregulation, LGBT, culture-related stressors, and trauma-related stressors); (b) refines the technological aspects of CA CIFFTA for web-based delivery; and (c) tests the preliminary efficacy of the new intervention and its delivery system in a randomized trial of 100 Hispanic adolescents and their parents. The investigators seek to reduce risk for repeated self-harm by showing treatment effects on depression, emotion regulation, substance use, and family functioning. Participants are randomly assigned to CA CIFFTA or Treatment-As-Usual and treatment covers a four month period.

Conditions: Self Harm, Depression, Emotion Dysregulation, Suicidal Ideation, Family Relations
Being tested: Computer Assisted CIFFTA, Behavioral: Traditional face-to-face treatment-no technology
Medical subject headings: Self-Injurious Behavior, Depression, Suicidal Ideation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Computer Assisted CIFFTABehavioural
Also called Behavioral: Family Therapy, Behavioral: Individual Therapy, Behavioral: Technology delivered psycho-educational modules
This is a hybrid intervention that includes individual work with the adolescent (e.g., Motivational Interviewing, diary card identification of triggers), computer assisted psychoeducational work, and intensive family therapy interventions.
Behavioral: Traditional face-to-face treatment-no technologyBehavioural
Also called Behavioral: Individual Therapy, Behavioral: Family Therapy
Community agencies provide mostly individual counseling but may add some family involvement in treatment planning.

Study groups in NCT03709472
Study group	Role	What they receive
Computer Assisted CIFFTA	Experimental	CA CIFFTA (Computer Assisted Culturally Informed and Flexible Family Based Treatment for Adolescents) consists of a hybrid intervention utilizing office-based CIFFTA and technology-delivered material. Over 16 weeks CIFFTA participants receive 45 minutes of face-to-face sessions plus approximately 45 minutes of web-based intervention per week. During the continuing care phase participants access website resources and receive targeted messages (e.g., handling family conflicts). CA CIFFTA will: 1) deliver psycho-educational modules (e.g., depression, emotion regulation), 2) collect diary-card information, and 3) provide additional resources. During videos parents and adolescents can report symptoms and information that is automatically transmitted to therapists and used in the next session Receives: Behavioral: Computer Assisted CIFFTA
Behavioral: Traditional face-to-face treatment-no technology	Active comparator	Participants randomized to Treatment-As-Usual (TAU) work over a 16-week period with their community agency. They may receive individual or family treatment. The team coordinates with the TAU agencies to minimize the overlap of data collected. The team will refer out to service locations that are most convenient for the participant. A great deal of thought has gone into the selection of the Treatment as Usual condition. The investigators wanted to compare CA CIFFTA's ability to retain and bring about change in participants with what is typically done in the community. Although running an in-house comparison condition gives more control of the delivery of services and tracking of clients, it is difficult to know how that compared to the services that are typically provided in the community Receives: Behavioral: Behavioral: Traditional face-to-face treatment-no technology

What is being measured

The primary outcome is the main question the study is designed to answer.

Columbia Suicide Severity Rating Scale (CSSRS) Suicide Ideation
The Columbia yields information on suicide ideation and Ideation with Intent. Youth were categorized as having or not having ideation and having or not having intent to suicide (yes/no). Endorsing any of these items as "yes" is a worse outcome. The number listed below is the number of participants that said "yes" to experiencing suicidal ideation in the last month.
Measured: Baseline, 4 months post baseline, 12 months post baseline

Secondary outcomes (4)

Number of Participants Who Reported Self-harm Behavior
The Deliberate Self-harm Inventory Youth Version (DSHI-Y) documents self-harm behavior. The data collected focused on the number of participants who reported "yes" to having engaged in self-harm in the past 30 days.
Measured: Baseline, 4 months post baseline, 12 months post baseline
Emotional Dysregulation Measured by Emotion Regulation Scale -Short Form (DERS)
Difficulties with Emotion Regulation Scale -Short form (DERS), is designed to assess emotional dysregulation using a 5-point Likert Scale. The total score is calculated from the sum of all items, with higher scores indicating greater problems with emotion regulation. Total summed scores can range from 18 - 90 but investigators report that average item score (1-5) rather than the sum so that is more easily interpretable in the 5 point Likert Scale.
Measured: Baseline, 4 months post baseline, 12 months post baseline
The Patient Health Questionnaire
The PHQ-9 incorporates the DSM-IV depression diagnostic criteria with other leading major depressive symptoms into a brief self-report tool. Depression Severity: 0 - none, 1-4 minimal, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe.
Measured: Baseline, 4 months post baseline, 12 months post baseline
Family Connectedness
The Family Connectedness (FC) scale includes seven items assessing communication and the relationship between parents and youth. A composite score was obtained. Two items measured communication and five items measured connectedness. The five Items were scored on a 1-10 scale and summed to a total connectedness score. Minimum score = 5 and Maximum score = 50. Higher scores mean better connections.
Measured: Baseline, 4 months post baseline, 12 months post baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Nov 201823 Aug 2023

First posted17 Oct 2018
Study start12 Nov 2018
Primary completion23 Aug 2023
Study completion23 Aug 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Self HarmStudies of the same condition, open and under way.
More trials run by University of MiamiThe 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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Randomization will be stratified by gender, type of self-harm, trauma exposure and LGBT status. The investigators will attempt to match overall contact hours (in the experimental condition some of these hours will be with technology). During the "continuing care" phase the CIFFTA families will interact with the therapist via the website for a period of 8 additional weeks. To match dosage time during aftercare, Treatment As Usual (TAU) will receive "check-in" telephone calls with the therapist.
Masking: None (open label)
Enrolment: 172 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03709472
Sponsor's protocol ID: 20170791
Other IDs: U54MD002266
Status last verified: Oct 2024
First submitted: 5 Oct 2018
Last updated: 5 Nov 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Interventions for self-harm in children and adolescents. Cochrane Database Syst Rev. 2021 Mar 7;3(3):CD013667. doi: 10.1002/14651858.CD013667.pub2.
PubMed 33677832

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Enrolling by invitation
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All Self Harm trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Computer Assisted Family Intervention to Treat Self- Harm Disparities in Latinas and Sexual/Gender Minority Youth (CA CIFFTA)
ClinicalTrials.gov ID: NCT03709472
Acronym / sponsor ID: 20170791
Conditions: Self Harm, Depression, Emotion Dysregulation, Suicidal Ideation, Family Relations
Study type: Interventional
Recruitment status: Completed
Enrolment: 172 participants (actual)
Lead sponsor: University of MiamiUniversity, hospital or other
Collaborators: National Institute on Minority Health and Health Disparities (NIMHD)
Study start: 12 Nov 2018 (actual)
Primary completion: 23 Aug 2023 (actual)
Study completion: 23 Aug 2023 (actual)
First posted: 17 Oct 2018 (actual)
Results: Posted 5 Nov 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Randomization will be stratified by gender, type of self-harm, trauma exposure and LGBT status. The investigators will attempt to match overall contact hours (in the experimental condition some of these hours will be with technology). During the "continuing care" phase the CIFFTA families will interact with the therapist via the website for a period of 8 additional weeks. To match dosage time during aftercare, Treatment As Usual (TAU) will receive "check-in" telephone calls with the therapist.

Arm	Type	Receives
Computer Assisted CIFFTA	Experimental	Behavioral: Computer Assisted CIFFTACA CIFFTA (Computer Assisted Culturally Informed and Flexible Family Based Treatment for Adolescents) consists of a hybrid intervention utilizing office-based CIFFTA and technology-delivered material. Over 16 weeks CIFFTA participants receive 45 minutes of face-to-face sessions plus approximately 45 minutes of web-based intervention per week. During the continuing care phase participants access website resources and receive targeted messages (e.g., handling family conflicts). CA CIFFTA will: 1) deliver psycho-educational modules (e.g., depression, emotion regulation), 2) collect diary-card information, and 3) provide additional resources. During videos parents and adolescents can report symptoms and information that is automatically transmitted to therapists and used in the next session
Behavioral: Traditional face-to-face treatment-no technology	Active comparator	Behavioral: Behavioral: Traditional face-to-face treatment-no technologyParticipants randomized to Treatment-As-Usual (TAU) work over a 16-week period with their community agency. They may receive individual or family treatment. The team coordinates with the TAU agencies to minimize the overlap of data collected. The team will refer out to service locations that are most convenient for the participant. A great deal of thought has gone into the selection of the Treatment as Usual condition. The investigators wanted to compare CA CIFFTA's ability to retain and bring about change in participants with what is typically done in the community. Although running an in-house comparison condition gives more control of the delivery of services and tracking of clients, it is difficult to know how that compared to the services that are typically provided in the community

Who may qualify

Ages: 11 to 18 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (4 listed)

be 11 to 18 years old;
self-report an act of self-harm in the past 6 months,
meet criteria for cut-off on two of the four underlying/maintaining factors (depression, emotion dysregulation, family conflict, substance use), and
live with at least one parent-figure who agrees to participate in assessments and treatment Participants should be willing and able to participate fully in the protocol (e.g., to accept assignment to either condition, to provide sufficient locator information for follow-up, to allow their treatment sessions to be recorded for fidelity/process assessment and supervision).

Key exclusion criteria (2 listed)

have a history of DSM V Developmental Disorders, Elective Mutism, Organic Mental Disorders, Schizophrenia, Delusional Disorder, Psychotic Disorder, and Bipolar Affective Disorder.
are actively in crisis and reporting current ideation with a specific plan and with means to complete the plan.

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
Computer Assisted CIFFTAAlso: Behavioral: Family Therapy, Behavioral: Individual Therapy, Behavioral: Technology delivered psycho-educational modulesThis is a hybrid intervention that includes individual work with the adolescent (e.g., Motivational Interviewing, diary card identification of triggers), computer assisted psychoeducational work, and intensive family therapy interventions.	Behavioural	Computer Assisted CIFFTA
Behavioral: Traditional face-to-face treatment-no technologyAlso: Behavioral: Individual Therapy, Behavioral: Family TherapyCommunity agencies provide mostly individual counseling but may add some family involvement in treatment planning.	Behavioural	Behavioral: Traditional face-to-face treatment-no technology

Primary outcome

Columbia Suicide Severity Rating Scale (CSSRS) Suicide Ideation
Time frame: Baseline, 4 months post baseline, 12 months post baseline
The Columbia yields information on suicide ideation and Ideation with Intent. Youth were categorized as having or not having ideation and having or not having intent to suicide (yes/no). Endorsing any of these items as "yes" is a worse outcome. The number listed below is the number of participants that said "yes" to experiencing suicidal ideation in the last month.

4 secondary outcomes

Number of Participants Who Reported Self-harm Behavior
Time frame: Baseline, 4 months post baseline, 12 months post baseline
Emotional Dysregulation Measured by Emotion Regulation Scale -Short Form (DERS)
Time frame: Baseline, 4 months post baseline, 12 months post baseline
The Patient Health Questionnaire
Time frame: Baseline, 4 months post baseline, 12 months post baseline
Family Connectedness
Time frame: Baseline, 4 months post baseline, 12 months post baseline

Results and safety

Results posted to the registry on 5 Nov 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Computer Assisted CIFFTA	84	84
Behavioral: Traditional Face-to-face Treatment-no Technology	84	84

Primary outcome: Columbia Suicide Severity Rating Scale (CSSRS) Suicide Ideation

Time frame: Baseline, 4 months post baseline, 12 months post baseline. Count of participants. Unit: Participants

Measure	Computer Assisted CIFFTA n = 38	Behavioral: Traditional Face-to-face Treatment-no Technology n = 27
Baseline	20	13
4-month assessment (post-treatment)	16	8
12-month assessment (12 months post baseline)	6	4

Population analysed: Only data from adolescents was collected. Missing data is because they did not provide sufficient item responses to calculate a score. Participants can respond with "don't know" or "refuse". This interferes with scoring.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 1 year. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Computer Assisted CIFFTA	0 of 42 (0%)	0 of 42 (0%)	0 of 42
Behavioral: Traditional Face-to-face Treatment-no Technology	0 of 42 (0%)	0 of 42 (0%)	0 of 42

Limitations and caveats (from the sponsor): The COVID disruptions reduced our overall sample size. A limitation is that we did not collect dosage data on treatment received by TAU participants. Finally, with only two timepoints and a small sample, it was impossible to analyze mediation. The best we could do was to explore plausible mediators (Emotion Regulation and Family Connectedness).

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 33677832Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Interventions for self-harm in children and adolescents. Cochrane Database Syst Rev. 2021 Mar 7;3(3):CD013667. doi: 10.1002/14651858.CD013667.pub2.
Individual participant dataSharing planned: No

Related trials for Self Harm

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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.

Daniel Santisteban, Ph.D. principal investigator

University of Miami

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 5 Nov 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?

Yes. Results are posted in the registry (first posted 5 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Columbia Suicide Severity Rating Scale (CSSRS) Suicide Ideation (time frame: Baseline, 4 months post baseline, 12 months post baseline). 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 NCT03709472, which also lists 1 linked publication.

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 5 Nov 2024.