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

Trial Summary

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 Behavioral Treatment for emotional disturbance?

Research shows that behavioral treatments can effectively change targeted behaviors in psychiatric patients and improve their overall functioning. For example, a study on chronic male psychiatric inpatients found that behavior modification techniques were successful in changing inappropriate behaviors and that these positive effects lasted for 6-12 months after treatment. ^{1 2 3 4 5}

Is behavioral treatment for emotional disturbance safe for humans?

The safety of behavioral treatments can vary depending on the specific methods used. Some treatments, like physical restraints, may cause injuries or psychological trauma, while medications like ketamine and droperidol have been studied for safety in emergency settings for severe behavioral disturbances. ^{6 7 8 9 10}

How does the Behavioral Treatment for Emotional Disturbance differ from other treatments?

The Behavioral Treatment for Emotional Disturbance is unique because it involves training occupational therapists to deliver specific behavioral techniques during therapy sessions, ensuring consistent and accurate treatment. This approach is interdisciplinary and focuses on regular, structured sessions, which may not be a feature of other treatments for emotional disturbances. ^{3 11 12 13 14}

What is the purpose of this trial?

The Family Connections study, is intended to disrupt disparities in mental health treatment access for children at-risk for childhood trauma (ACEs) and/or serious emotional disturbance (SED). "Family Connections" will use mobile clinical and family support teams to improve mental health outcomes. This clinical innovation, nested in an integrated system-of-care will be piloted for children, ages 3-18 yrs., with SED who receive primary care through Cambridge Health Alliance.

Research Team

Katherine E Grimes, MD, MPH

Principal Investigator

Cambridge Health Alliance

Eligibility Criteria

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 am between 3 and 17.5 years old.

My primary care doctor from a CHA site referred me for a child mental health or substance use assessment.

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

Timeline

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

Treatment Details

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.

Participant Groups

Group I: Treatment as Usual Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Cambridge Health Alliance

Lead Sponsor

Trials

65

Recruited

22,400+

Findings from Research

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]

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 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]

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]

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]

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]

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]

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]

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]

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]

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]

References

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

Behavioral consultation with difficult to treat psychiatric patients. [2019]

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

Toward impacting medical and psychiatric comorbidities in persons with intellectual/developmental disabilities: an initial prospective analysis. [2020]

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

An interdisciplinary behavioral treatment program for depressed geriatric rehabilitation inpatients. [2019]

4. Netherlands pubmed.ncbi.nlm.nih.gov

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

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

Adverse effects of poor behavior management of an inpatient's difficult behaviors. [2019]

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

Ketamine as Rescue Treatment for Difficult-to-Sedate Severe Acute Behavioral Disturbance in the Emergency Department. [2022]

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

Management of behavioral emergencies. [2005]

8. Australia pubmed.ncbi.nlm.nih.gov

Structured team approach to the agitated patient in the emergency department. [2022]

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

Parenteral sedation of elderly patients with acute behavioral disturbance in the ED. [2022]

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

Experiences of Individuals Who Were Physically Restrained in the Emergency Department. [2020]

11. United States 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. [2019]

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

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

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

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

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

Effects of an interdependent group contingency on the transition behavior of middle school students with emotional and behavioral disorders. [2018]