Behavioral Treatment for Emotional Disturbance

Overseen By Katherine Grimes, Md, MPH

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Cambridge Health Alliance

Disqualifiers: Over 17.5 years, Not MassHealth, others

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

Compensation: Varies

Number of Visits: 6

Duration: 6 months

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve mental health care access for children facing serious emotional challenges or at risk of trauma. The study tests a new approach using mobile support teams to enhance mental health services. One group will receive this new behavioral treatment intervention, while another will continue with their usual treatment. It is designed for children aged 3 to 18 who are part of the Cambridge Health Alliance system and have MassHealth, particularly if there are concerns about their mental health or substance use. As an unphased trial, this study provides a unique opportunity for participants to contribute to innovative mental health solutions for children.

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 prior data suggests that this behavioral treatment is safe for children with serious emotional disturbance?

Research shows that the "Family Connections" program, part of the behavioral treatment under study, has been widely used to assist families facing mental health challenges. Previous studies have found it beneficial, particularly for caregivers of young people with mental health issues. This program is based on Dialectical Behavior Therapy (DBT), a well-known method for managing emotions and behaviors.

Specific data on negative effects for this type of treatment is lacking, but its common use and focus on helping families suggest it is generally well-received. Since this is not a trial involving drugs or medical devices, the risks are typically lower compared to those types of trials. The main goal is to provide support and improve mental health outcomes for children at risk. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Family Connections Intervention for treating emotional disturbances because it takes a unique approach by actively involving family members in the therapy process. Unlike traditional treatments that might focus solely on the individual, this method leverages family dynamics to provide support and improve emotional regulation. This collaborative approach could lead to more sustainable outcomes as it builds a support system within the family itself, potentially enhancing both communication and understanding.

What evidence suggests that the Family Connections intervention could be effective for serious emotional disturbance?

Research has shown that the Family Connections program, which participants in this trial may receive, helps improve mental health. In one study, participants experienced less depression, anxiety, and stress. The program also significantly reduced challenges for caregivers of children with serious emotional issues. Another study found positive effects on the school performance of students with emotional difficulties. These results suggest that Family Connections effectively enhances the mental health and well-being of both children and their families. ^{1 2 3 6 7}

Who Is on the Research Team?

Katherine E Grimes, MD, MPH

Principal Investigator

Cambridge Health Alliance

Are You a Good Fit for This Trial?

The Family Connections trial is for children aged 3-18 with potential mental health or substance use issues, identified by primary care physicians at CHA sites. Participants must have a positive mental health screen or parental/PCP concern and be enrolled in MassHealth. It's not suitable for those outside this age range or care network.

Inclusion Criteria

I or my child screened positive for mental health/substance use, or there's concern from a parent or doctor.

I am enrolled in MassHealth.

I am between 3 and 17.5 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Family Connections intervention using mobile clinical and family support teams

6 months

Regular visits as part of the intervention

Follow-up

Participants are monitored for changes in clinical functioning and family perceptions of care

6 months

Follow-up assessments at 6 months and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Behavioral Treatment

Trial Overview This study tests a mobile clinical and family support team approach to improve mental health outcomes for at-risk children with serious emotional disturbances (SED). The intervention includes integrated systems of care provided by the Cambridge Health Alliance.

How Is the Trial Designed?

Group I: Active Comparator: Family Connections Intervention Active Control 1 Intervention

Group II: Treatment as Usual Active Control 1 Intervention

Who Is Running the Clinical Trial?

Cambridge Health Alliance

Lead Sponsor

Trials

65

Recruited

22,400+

Published Research Related to This Trial

Behavioral consultation for psychiatric inpatients has been shown to effectively change targeted behaviors, but its impact on recidivism and overall patient functioning is less clear.

In a study involving 7 patients, behavioral consultation was associated with changes in hospital admission frequency and duration, as well as improvements in patients' functioning, suggesting potential benefits beyond immediate behavior modification.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral consultation with difficult to treat psychiatric patients. Mori, DL., Blake, DD.[2019]

In a study of 141 adults with intellectual disabilities and behavioral disorders, significant improvement in behavioral problems was observed at six months, particularly for those with anxiety disorders, indicating the effectiveness of psychiatric and behavioral treatments.

Patients with more visible behavioral symptoms were more likely to receive behavioral support, while those with less overt symptoms were referred for counseling, suggesting a tailored approach to treatment based on symptom presentation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Toward impacting medical and psychiatric comorbidities in persons with intellectual/developmental disabilities: an initial prospective analysis. Gentile, JP., Gillig, PM., Stinson, K., et al.[2020]

Inadequate training of staff in behavior therapy techniques can lead to inconsistent application of interventions, which may worsen aggressive behaviors in institutionalized clients with conditions like schizophrenia.

The case highlights the critical need for proper behavior management training and emphasizes the importance of data collection to effectively evaluate the outcomes of clinical interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse effects of poor behavior management of an inpatient's difficult behaviors. Hilton, NZ., Simmons, JL.[2019]

The study used an ABAB design to assess the effectiveness of a group contingency intervention for middle school students with emotional and behavioral disorders (EBDs), showing significant improvements in their transition behavior.

Implemented by a single teacher across three classes, the intervention resulted in a higher percentage of students being ready to start class on time, demonstrating the feasibility and effectiveness of this approach in alternative educational settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of an interdependent group contingency on the transition behavior of middle school students with emotional and behavioral disorders. Hawkins, RO., Haydon, T., McCoy, D., et al.[2018]

In a study of 49 patients with severe acute behavioral disturbance who had not responded to previous sedation attempts, ketamine was effective, with only 10% of patients failing to achieve sedation within 120 minutes or requiring additional sedation within 1 hour.

The median dose of ketamine administered was 300 mg, and doses less than 200 mg were linked to treatment failure, suggesting that a higher dose (4 to 5 mg/kg) may be necessary for effective sedation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ketamine as Rescue Treatment for Difficult-to-Sedate Severe Acute Behavioral Disturbance in the Emergency Department. Isbister, GK., Calver, LA., Downes, MA., et al.[2022]

In a study of 122 patients with acute behavioral disturbances in the emergency department, the majority had underlying issues such as self-harm, substance intoxication, or psychiatric conditions, highlighting the need for targeted interventions.

The structured team approach to managing these emergencies was effective, with combined pharmacological sedation and physical restraint used in 46% of cases, and only one staff injury reported, indicating a high level of safety in the management process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Structured team approach to the agitated patient in the emergency department. Downes, MA., Healy, P., Page, CB., et al.[2022]

An aggression replacement and self-management training program significantly reduced aggressive behavior in four junior high students identified as seriously emotionally disturbed, with aggressive incidents occurring in 50% of observed intervals before treatment.

After 8 weeks of training, the students showed improved prosocial skills, indicating that self-management techniques helped sustain these positive behaviors, although aggression increased when treatment was paused.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of a self-management training package on the transfer of aggression control procedures in the absence of supervision. Ninness, HA., Ellis, J., Miller, WB., et al.[2019]

An innovative interdisciplinary behavioral treatment protocol for depression was developed, where occupational therapists were trained to implement specific behavioral techniques during therapy sessions.

Early results suggest that this treatment can be delivered reliably and accurately, potentially improving functional independence for individuals with depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An interdisciplinary behavioral treatment program for depressed geriatric rehabilitation inpatients. Lichtenberg, PA., Kimbarow, ML., MacKinnon, D., et al.[2019]

The treatment classroom for emotionally disturbed adolescents focuses on both educational and counseling interventions to help change maladaptive behaviors and emotions.

The study highlights the importance of the roles of staff and the interactions between the adolescents, the treatment environment, and the care workers in promoting effective therapeutic outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The counseling role of the child and youth worker in a treatment classroom. Pazaratz, D.[2004]

Despite the development of evidence-based treatments (EBTs) for mental health issues, a significant number of individuals still do not receive the necessary services, highlighting a critical gap in mental health care access.

Current treatment models, primarily one-to-one in-person therapy, are insufficient for reaching all those in need, indicating the necessity for diverse delivery methods and a deeper understanding of how therapeutic changes occur.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence-based treatment research: Advances, limitations, and next steps. Kazdin, AE.[2022]

Accurate diagnosis and management are crucial for treating behaviorally disordered patients in emergency departments, with treatment often starting before a definitive diagnosis is made.

A structured approach categorizes behavioral emergencies into three intervention levels: nonpharmacological for conditions like suicidal states, minimal pharmacological for issues like adjustment disorders, and maximal pharmacological for severe cases such as agitated psychosis or substance withdrawal.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of behavioral emergencies. Tueth, MJ.[2005]

Droperidol was found to be effective for sedation in elderly patients with acute behavioral disturbance, with a median time to sedation of 30 minutes for those receiving 10 mg and 21 minutes for those receiving 5 mg.

Adverse effects were relatively uncommon, occurring in only 5 patients, and no cases of QT prolongation were reported, suggesting that droperidol is a safe option for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parenteral sedation of elderly patients with acute behavioral disturbance in the ED. Calver, L., Isbister, GK.[2022]

A qualitative study involving 25 adults revealed that most individuals who experienced physical restraint in the emergency department felt coerced and reported harmful experiences related to their treatment, highlighting the psychological impact of such interventions.

Participants expressed a strong desire for compassionate care and therapeutic engagement, suggesting that future approaches to managing agitation in the ED should focus on minimizing harm and improving patient-centered care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Experiences of Individuals Who Were Physically Restrained in the Emergency Department. Wong, AH., Ray, JM., Rosenberg, A., et al.[2020]

The Behavior Modification Program (BMP) effectively changed three target behaviors in 15 chronic schizophrenic male patients, demonstrating the efficacy of positive reinforcement and response-cost techniques over 70 to 85 treatment sessions.

Most positive changes from the BMP persisted for 6-12 months after treatment, leading to 14 out of 15 participants being discharged to community foster homes, indicating a significant improvement in their overall functioning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of long-term therapeutic efficacy of behavior modification program with chronic male psychiatric inpatients. Peniston, EG.[2019]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35646607/

Effectiveness of family connections intervention for ... Results: There is a statistically significant improvement in levels of burden (η 2 = 0.471), depression, anxiety, and stress (η 2 = 0.279), ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06662357

Study Details | NCT06662357 | Family Connections "Family Connections" will use mobile clinical and family support teams to improve mental health outcomes.

3. ies.ed.gov ies.ed.gov/use-work/awards/parent-connectors-parent-support-program-improve-outcomes-students-who-have-emotional-disturbances

A Parent Support Program to Improve Outcomes for Students ... Students with emotional disturbances have the worst educational outcomes compared to their peers with other disabilities. Children with an emotional disturbance ...

4. trialx.com trialx.com/clinical-trials/listings/299476/family-connections/

Family Connections | Clinical Research Trial Listing ... "Family Connections" will use mobile clinical and family support teams to improve mental health outcomes.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8077080/

Evaluating the effectiveness of the Family Connections ... Our findings demonstrate the positive impact of the FC program for caregivers of youth with mental health challenges beyond the previous focus ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8750943/

“Family Connections”, a DBT-Based Program for Relatives ... “Family Connections” (FC) is an internationally renowned DBT-based program that supports the families and caregivers of people with borderline personality ...

7. pathwaysrtc.pdx.edu pathwaysrtc.pdx.edu/pdf/pbFamilyConnections.pdf

Family Connections Research & Demonstration Project The major findings of the study revealed that families in the intervention group were significantly more likely to initiate children's mental health services ...