Adolescent - Emotional ProblemNCT04132284
DBT-Based Parenting Intervention for Parents of Youth at Risk for Suicide
A study testing DBT-Based Parenting Intervention and Treatment as Usual in people with Adolescent - Emotional Problem and Suicide and Self-harm, run by Stanford University at 1 site in United States.
Trial summary
The purpose of the present study is to conduct a pilot randomized clinical trial (RCT) of an 8-10 session DBT-based parenting intervention (DBT PI) plus standard Dialectical Behavior Therapy delivered in the context of an intensive outpatient program (DBT IOP) to DBT IOP alone. Read more about this study
- Who is it for?
- Ages 13 to 18 years
- Conditions the study is for
- Adolescent - Emotional Problem, Suicide and Self-harm, Parenting
- What is being tested?
- DBT-Based Parenting Intervention and Treatment as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2020to 16 Jun 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 13 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 1) youth is enrolled in CHC-Stanford RISE program; 2) youth and parent are willing to participate, and 3) youth and parent speak English.
Who cannot join
- 1) the youth or parent has a psychiatric or medical condition that would interfere with their ability to participate in study assessments and/or treatment (such as acute psychosis, neurological impairment, malnutrition due to severe anorexia).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Randomized Controlled Trial of a DBT-based Parenting Intervention
The purpose of the present study is to conduct a pilot randomized clinical trial (RCT) of an 8-10 session DBT-based parenting intervention (DBT PI) plus standard Dialectical Behavior Therapy delivered in the context of an intensive outpatient program (DBT IOP) to DBT IOP alone. The long term goal of the research is to determine if augmenting standard DBT with additional parenting intervention improves youth treatment response on suicide-related outcomes (i.e., suicidal ideation, non-suicidal self-injury and suicide attempts). The goal of this pilot RCT is to collect preliminary data needed for a larger RCT, including feasibility, acceptability, safety, tolerability, engagement of the presumed mechanism of change (changes in parent emotions and behaviors) and signal detection of any changes in youth suicide-related outcomes.
Read the detailed description
The present study is a pilot RCT of a DBT parenting intervention (DBT PI). The investigators will enroll N = 40 pairs of youth and parents enrolled in a DBT intensive outpatient program that delivers standard DBT (DBT IOP). This program, called the RISE program, is jointly run by Stanford and Children's Health Council (CHC). CHC is a community mental health clinic located in Palo Alto and is where the IOP is housed. All research procedures will be conducted by Stanford faculty and staff. Parents and youth who provide informed consent will be randomly assigned to receive the DBT PI + DBT IOP or DBT IOP only. Parents assigned to the DBT PI + DBT IOP will be offered 10 sessions of DBT-based parenting interventions. Youth will participate in study assessments only and will not receive additional treatment as part of the study (i.e., they will receive DBT IOP only). Study participation is optional and will not impact the family's ability to participate in the DBT IOP. Youth will be enrolled in the IOP program as part of standard clinical practices, regardless of whether or not they choose to participate in the study. Assessments will be conducted at baseline, 3-month follow-up (end of DBT IOP program) and 6 month follow-up. Both parents will be encouraged to take part in the intervention, however; the participation of only one parent will be required. The intervention will consist of 8-10 individual parent sessions, to be completed within one week after the teen completes the IOP program. Sessions will be 1 hour in length and will be offered weekly. Therapists may see parents more than once a week if needed, as long as the total number of sessions does not exceed 10. Sessions will follow the standard agenda used for DBT skills training: 1) mindfulness practice, 2) homework review, 3) teaching of a new skill; 4) practice of the new skill; and 5) assignment of new homework (Linehan, 1993). The intervention will utilize the Middle Path module from the DBT Skills Manual for Adolescents (Rathus \& Miller, 2015), which was created by the developers of DBT for adolescents and includes both instructions for therapists and handouts for clients.
- Being tested
- DBT-Based Parenting Intervention, Treatment as Usual
- Medical subject headings
- Suicide, Self-Injurious Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DBT-Based Parenting InterventionBehavioural
The intervention will consist of 8-10 individual parent sessions, to be completed within one week after the teen completes the IOP program. Sessions will be 1 hour in length and will be offered weekly. Therapists may see parents more than once a week if needed, as long as the total number of sessions does not exceed 10. Sessions will follow the standard agenda used for DBT skills training: 1) mindfulness practice, 2) homework review, 3) teaching of a new skill; 4) practice of the new skill; and 5) assignment of new homework (Linehan, 1993). The intervention will utilize the Middle Path module of the DBT Skills Manual for Adolescents (Rathus \& Miller, 2015), which was created by the developers of DBT for adolescents and includes both instructions for therapists and handouts for clients.
Treatment as UsualBehavioural
No parenting intervention provided beyond standard practices in DBT IOP program.
| Study group | Role | What they receive |
|---|---|---|
| DBT IOP plus DBT PI | Experimental | Standard Dialectical Behavior Therapy (DBT) delivered in the context of an intensive outpatient program (DBT IOP) for adolescents plus an 8-10 session DBT-based parenting intervention (DBT PI) Receives: Behavioral: DBT-Based Parenting Intervention |
| DBT IOP alone | Active comparator | No parenting intervention provided beyond what is part of the DBT IOP treatment as usual. Receives: Behavioral: Treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Youth Self-Harm Episodes
Measured: 6 months
Youth Suicidal Ideation
Measured: 6 months
Secondary outcomes (5)
Parent Emotion Dysregulation
Measured: 6 months
Parent Depressive Symptoms
Measured: 6 months
Parent Caregiver Strain
Measured: 6 months
Family Conflict
Measured: 6 months
Family Functioning McMaster Family Assessment Device
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2019
- Study start1 Jul 2020
- Primary completion16 Dec 2022
- Study completion16 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent - Emotional ProblemStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michele Berk, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04132284
- Sponsor's protocol ID
- 50613
- Status last verified
- Nov 2023
- First submitted
- 15 Oct 2019
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- 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 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Randomized Controlled Trial of a DBT-based Parenting Intervention
- ClinicalTrials.gov ID
- NCT04132284
- Acronym / sponsor ID
- 50613
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 16 Dec 2022 (actual)
- Study completion
- 16 Jun 2023 (actual)
- First posted
- 18 Oct 2019 (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 the present study is to conduct a pilot randomized clinical trial (RCT) of an 8-10 session DBT-based parenting intervention (DBT PI) plus standard Dialectical Behavior Therapy delivered in the context of an intensive outpatient program (DBT IOP) to DBT IOP alone. The long term goal of the research is to determine if augmenting standard DBT with additional parenting intervention improves youth treatment response on suicide-related outcomes (i.e., suicidal ideation, non-suicidal self-injury and suicide attempts). The goal of this pilot RCT is to collect preliminary data needed for a larger RCT, including feasibility, acceptability, safety, tolerability, engagement of the presumed mechanism of change (changes in parent emotions and behaviors) and signal detection of any changes in youth suicide-related outcomes.
Detailed description
The present study is a pilot RCT of a DBT parenting intervention (DBT PI). The investigators will enroll N = 40 pairs of youth and parents enrolled in a DBT intensive outpatient program that delivers standard DBT (DBT IOP). This program, called the RISE program, is jointly run by Stanford and Children's Health Council (CHC). CHC is a community mental health clinic located in Palo Alto and is where the IOP is housed. All research procedures will be conducted by Stanford faculty and staff. Parents and youth who provide informed consent will be randomly assigned to receive the DBT PI + DBT IOP or DBT IOP only. Parents assigned to the DBT PI + DBT IOP will be offered 10 sessions of DBT-based parenting interventions. Youth will participate in study assessments only and will not receive additional treatment as part of the study (i.e., they will receive DBT IOP only). Study participation is optional and will not impact the family's ability to participate in the DBT IOP. Youth will be enrolled in the IOP program as part of standard clinical practices, regardless of whether or not they choose to participate in the study. Assessments will be conducted at baseline, 3-month follow-up (end of DBT IOP program) and 6 month follow-up. Both parents will be encouraged to take part in the intervention, however; the participation of only one parent will be required. The intervention will consist of 8-10 individual parent sessions, to be completed within one week after the teen completes the IOP program. Sessions will be 1 hour in length and will be offered weekly. Therapists may see parents more than once a week if needed, as long as the total number of sessions does not exceed 10. Sessions will follow the standard agenda used for DBT skills training: 1) mindfulness practice, 2) homework review, 3) teaching of a new skill; 4) practice of the new skill; and 5) assignment of new homework (Linehan, 1993). The intervention will utilize the Middle Path module from the DBT Skills Manual for Adolescents (Rathus \& Miller, 2015), which was created by the developers of DBT for adolescents and includes both instructions for therapists and handouts for clients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DBT IOP plus DBT PI | Experimental | Behavioral: DBT-Based Parenting InterventionStandard Dialectical Behavior Therapy (DBT) delivered in the context of an intensive outpatient program (DBT IOP) for adolescents plus an 8-10 session DBT-based parenting intervention (DBT PI) |
| DBT IOP alone | Active comparator | Behavioral: Treatment as UsualNo parenting intervention provided beyond what is part of the DBT IOP treatment as usual. |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 1) youth is enrolled in CHC-Stanford RISE program; 2) youth and parent are willing to participate, and 3) youth and parent speak English.
Key exclusion criteria (1 listed)
- 1) the youth or parent has a psychiatric or medical condition that would interfere with their ability to participate in study assessments and/or treatment (such as acute psychosis, neurological impairment, malnutrition due to severe anorexia).
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 |
|---|---|---|
| DBT-Based Parenting InterventionThe intervention will consist of 8-10 individual parent sessions, to be completed within one week after the teen completes the IOP program. Sessions will be 1 hour in length and will be offered weekly. Therapists may see parents more than once a week if needed, as long as the total number of sessions does not exceed 10. Sessions will follow the standard agenda used for DBT skills training: 1) mindfulness practice, 2) homework review, 3) teaching of a new skill; 4) practice of the new skill; and 5) assignment of new homework (Linehan, 1993). The intervention will utilize the Middle Path module of the DBT Skills Manual for Adolescents (Rathus \& Miller, 2015), which was created by the developers of DBT for adolescents and includes both instructions for therapists and handouts for clients. | Behavioural | DBT IOP plus DBT PI |
| Treatment as UsualNo parenting intervention provided beyond standard practices in DBT IOP program. | Behavioural | DBT IOP alone |
Primary outcome
Number of Youth Self-Harm Episodes
Time frame: 6 months
Youth Suicidal Ideation
Time frame: 6 months
5 secondary outcomes
Parent Emotion Dysregulation
Time frame: 6 months
Parent Depressive Symptoms
Time frame: 6 months
Parent Caregiver Strain
Time frame: 6 months
Family Conflict
Time frame: 6 months
Family Functioning McMaster Family Assessment Device
Time frame: 6 months
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 29 Nov 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DBT-Based Parenting Intervention and Treatment as Usual in people with Adolescent - Emotional Problem and Suicide and Self-harm, run by Stanford 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 1 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: finished, as of the sponsor's last update on 29 Nov 2023. 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?
Number of Youth Self-Harm Episodes (time frame: 6 months). The study lists 2 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 29 Nov 2023.