DBT-Based Parenting Intervention for Emotional Disturbance

Recruiting at 1 trial location

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Acute psychosis, Neurological impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 7

Duration: 4 weeks

40 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of the present study is to conduct a pilot randomized clinical trial (RCT) of a parent coaching intervention for parents of youth hospitalized for suicidal ideation, suicide attempt(s), or non-suicidal self-injury. Parents will receive either the parent coaching intervention (which includes safety planning and behavioral parenting skills training with a clinician and assistance with linkage to follow-up care by a case manager) or treatment as usual (TAU) for the inpatient unit. The long-term goal of the research is to determine if augmenting standard inpatient treatment 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.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What data supports the effectiveness of the treatment DBT-Based Parenting Intervention for Emotional Disturbance?

Research shows that Dialectical Behavior Therapy (DBT) is effective in improving emotion regulation, which is crucial for parenting. Additionally, coaching parents with in vivo feedback (real-time guidance) has been shown to significantly improve parenting skills, suggesting that DBT-based interventions could be beneficial for parents dealing with emotional disturbances. ^{1 2 3 4 5}

Is the DBT-Based Parenting Intervention safe for humans?

Dialectical Behavior Therapy (DBT) has been used safely in various settings, including for adolescents and their parents, to address emotional and behavioral issues. While specific safety data for the DBT-Based Parenting Intervention is limited, DBT generally includes safety planning measures and risk management strategies to ensure participant safety. ^{1 6 7 8 9}

How is the DBT-Based Parenting Intervention different from other treatments for emotional disturbance?

The DBT-Based Parenting Intervention is unique because it focuses on improving parents' ability to regulate their emotions, which is crucial for effective parenting and preventing emotional issues in children. Unlike other treatments, it uses principles from Dialectical Behavior Therapy (DBT) to target emotion dysregulation, a common factor in many mental health issues, making it a novel approach for addressing emotional disturbances through parenting. ^{1 2 5 10 11}

Eligibility Criteria

This trial is for youth aged 12-18, hospitalized for suicidal thoughts or self-harm at the Stanford unit of Mills Peninsula Medical Center. They must be in high school and living with parents who can participate. Both youth and parents should speak English well enough for treatment and assessments.

Inclusion Criteria

I am currently hospitalized for thoughts or actions related to suicide or self-harm.

At least one parent/guardian is willing to participate in the study intervention

Exclusion Criteria

I do not have a condition like severe mental illness or malnutrition that would stop me from participating fully.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Parents receive a 4-session DBT-based parenting intervention, including safety planning and behavioral parenting skills training

4 weeks

4 sessions (in-person or virtual)

Follow-up

Participants are monitored for changes in parent emotions and behaviors, and youth suicide-related outcomes

12 months

Assessments at baseline, 3, 6, and 12 months

Treatment Details

Interventions

• DBT-Based Parenting Intervention
• Treatment as usual

Trial Overview The study tests a parent coaching intervention against standard care. The new approach includes safety planning, behavioral skills training, and help with follow-up care to see if it improves outcomes related to suicide in hospitalized youth.

Participant Groups

Group I: PI+ Inpatient Treatment as Usual Experimental Treatment 2 Interventions

Standard inpatient treatment delivered in the context of an adolescent psychaitric inpatient unit plus an 4 session DBT-based parenting intervention PI) Intervention: Behavioral: DBT-Based Parenting Intervention

Group II: Inpatient Treatment alone Active Control 1 Intervention

No parenting intervention provided beyond what is part of the inpatient treatment as usual. Intervention: Behavioral: Treatment as Usual

DBT-Based Parenting Intervention is already approved in United States for the following indications:

Approved in United States as DBT-Based Parenting Intervention for:

• Suicidal ideation in youth
• Non-suicidal self-injury in youth
• Suicide attempts in youth

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Findings from Research

Dialectical behavior therapy (DBT) is effective for various mental disorders by specifically targeting emotion dysregulation, a common issue across many psychological conditions.

DBT's application has expanded to include improving parenting quality, which can help prevent psychopathology in children, highlighting its versatility and potential benefits beyond traditional diagnostic categories.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identifying novel applications of dialectical behavior therapy: considering emotion regulation and parenting. Zalewski, M., Lewis, JK., Martin, CG.[2022]

In a study involving 60 mothers and their children aged 2 to 7, those who received in vivo coaching during parent-child interactions showed significant improvements in parenting skills compared to those who did not receive coaching.

The results indicate that in vivo feedback is a crucial mechanism for enhancing parenting abilities, as it led to skill gains that were independent of the parents' initial abilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Coaching parents to change: the impact of in vivo feedback on parents' acquisition of skills. Shanley, JR., Niec, LN.[2011]

Dialectical Behavior Therapy for adolescents (DBT-A) has shown promising improvements in treating borderline personality disorder, but there is a need for more research to establish its effectiveness, especially regarding family involvement in treatment.

Innovative approaches, such as integrating smartphone-based assessments and interventions into DBT-A, could enhance therapy by providing timely skills and improving therapist-patient interactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meeting report of the 2nd German dialectical behavior therapy for adolescents network meeting. Hammerle, F., Bürger, A., Kaess, M., et al.[2020]

Mothers with Borderline Personality Disorder (BPD) reported that parenting is a significant source of stress, often accompanied by feelings of guilt and uncertainty, highlighting the need for targeted support in this area.

The study identified a strong desire among mothers with BPD for parenting issues to be more integrated into their Dialectical Behavior Therapy (DBT) skills training, suggesting potential modifications to enhance treatment effectiveness for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Qualitative Assessment of the Parenting Challenges and Treatment Needs of Mothers with Borderline Personality Disorder. Zalewski, M., Stepp, SD., Whalen, DJ., et al.[2020]

Behavioral parent training (BPT) is an effective treatment for ADHD, improving both child behavior and parenting practices, as well as reducing parenting stress and enhancing classroom behavior.

Despite its effectiveness, research on BPT for ADHD is less comprehensive than for other disorders like oppositional defiant disorder (ODD) and conduct disorder (CD), highlighting the need for further studies to understand factors affecting treatment outcomes, especially given the high comorbidity between ADHD and these disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancements to the behavioral parent training paradigm for families of children with ADHD: review and future directions. Chronis, AM., Chacko, A., Fabiano, GA., et al.[2019]

In a study involving 100 parents of adolescents undergoing dialectical behaviour therapy for adolescents (DBT-A), significant reductions in parental burden, grief, and stress were observed after a 16-week program, indicating the therapy's positive impact on parents as well as their children.

Parents reported that the skills learned in the DBT-A program were beneficial for both their own needs and those of their child, suggesting that involving parents in the therapy can enhance overall family well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An evaluation of the skills group component of DBT-A for parent/guardians: a mixed methods study. Flynn, D., Gillespie, C., Joyce, M., et al.[2023]

Dialectical behaviour therapy for adolescents (DBT-A) was effectively implemented in publicly funded mental health services in Ireland, involving 54 clinicians and 84 adolescents over a 16-week program.

Participants in the DBT-A program showed significant reductions in self-harm, suicidal thoughts, and depression, along with decreased hospital admissions and emergency visits, indicating its efficacy in treating emotional and behavioral dysregulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Innovations in Practice: Dialectical behaviour therapy for adolescents: multisite implementation and evaluation of a 16-week programme in a public community mental health setting. Flynn, D., Kells, M., Joyce, M., et al.[2020]

Parents and carers of adolescents in a DBT-A program reported significant improvements in their distress levels and family communication after participating in a 6-month skills group intervention, with 41 participants completing the study.

Qualitative feedback from participants highlighted positive changes in family dynamics and personal well-being, suggesting that parental involvement in DBT-A can enhance the overall effectiveness of the treatment for adolescents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parent and Carer Skills Groups in Dialectical Behaviour Therapy for High-Risk Adolescents with Severe Emotion Dysregulation: A Mixed-Methods Evaluation of Participants' Outcomes and Experiences. Smith, L., Hunt, K., Parker, S., et al.[2023]

Dialectical behavior therapy (DBT) is an effective treatment for individuals with borderline personality disorder, specifically targeting life-threatening behaviors like suicide attempts and self-injury.

DBT incorporates various strategies for risk management and safety planning, such as diary cards and phone coaching, to help clients commit to reducing harmful behaviors throughout their treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk management in dialectical behavior therapy: Treating life-threatening behaviors as problems to be solved. Alba, MC., Bailey, KT., Coniglio, KA., et al.[2022]

In a study involving 216 families, maternal mental distress was found to negatively impact the effectiveness of Brief Parent Training (BPT) in reducing conduct problems in children, regardless of whether they received BPT or a comparison intervention.

Lower levels of maternal distress were associated with fewer conduct problems reported by both parents and teachers, highlighting the importance of addressing maternal mental health to improve outcomes for children with conduct issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Maternal mental distress influences child outcomes in brief parent training. Kjøbli, J., Naerde, A., Bjørnebekk, G., et al.[2020]

Behavioral Parent Training (BPT) is the standard treatment for young children (ages 3 to 8) with disruptive behavior disorders and may also help reduce internalizing problems and improve family dynamics.

The review explores the mechanisms by which BPT may lead to broader treatment effects, including alleviating caregiver depressive symptoms, suggesting that understanding these mechanisms could enhance future clinical research and practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cascading effects of BPT for child internalizing problems and caregiver depression. Gonzalez, MA., Jones, DJ.[2023]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Identifying novel applications of dialectical behavior therapy: considering emotion regulation and parenting. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Coaching parents to change: the impact of in vivo feedback on parents' acquisition of skills. [2011]

3. England pubmed.ncbi.nlm.nih.gov

Meeting report of the 2nd German dialectical behavior therapy for adolescents network meeting. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

A Qualitative Assessment of the Parenting Challenges and Treatment Needs of Mothers with Borderline Personality Disorder. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Enhancements to the behavioral parent training paradigm for families of children with ADHD: review and future directions. [2019]

6. England pubmed.ncbi.nlm.nih.gov

An evaluation of the skills group component of DBT-A for parent/guardians: a mixed methods study. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Innovations in Practice: Dialectical behaviour therapy for adolescents: multisite implementation and evaluation of a 16-week programme in a public community mental health setting. [2020]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Parent and Carer Skills Groups in Dialectical Behaviour Therapy for High-Risk Adolescents with Severe Emotion Dysregulation: A Mixed-Methods Evaluation of Participants' Outcomes and Experiences. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Risk management in dialectical behavior therapy: Treating life-threatening behaviors as problems to be solved. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Maternal mental distress influences child outcomes in brief parent training. [2020]

11. United States pubmed.ncbi.nlm.nih.gov

Cascading effects of BPT for child internalizing problems and caregiver depression. [2023]