CLINICAL TRIAL

Family Centered Treatment for Problem Behavior

Recruiting · < 18 · All Sexes · Charlotte, NC

FCT Study: Reducing the Need for Out-of-Home Placements

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About the trial for Problem Behavior

Eligible Conditions
Mental Disorders · Behavioural Problem · Problem Behavior · Emotional Problems · Psychiatric Disorder NOS

Treatment Groups

This trial involves 2 different treatments. Family Centered Treatment is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Family Centered Treatment
BEHAVIORAL
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Level II or Level III Out of Home Placement
BEHAVIORAL

Eligibility

This trial is for patients born any sex aged 18 and younger. There are 3 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Youth must have a caregiver and home environment with which to implement FCT
Youth must live within a county in NC where FCT service providers implement FCT.
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 1 year, 2 years, 3 years, 4 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 1 year, 2 years, 3 years, 4 years.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Family Centered Treatment will improve 4 primary outcomes and 56 secondary outcomes in patients with Problem Behavior. Measurement will happen over the course of baseline, 6 months, 12 months, 18 months.

Out of home placement
BASELINE, 6 MONTHS, 12 MONTHS, 18 MONTHS
The Service Assessment for Children & Adolescents (SACA) will be used to ascertain caregiver reports of whether or not a child had an out of home place for behavioral or emotional or drug or alcohol problems. A series of yes/no questions will ask if their child has stayed overnight in a hospital, treatment center, group or foster home, juvenile justice facility, detention center/prison or jail, or emergency shelter for behavioral, emotional, or drug or alcohol problems. A variable will be created to indicate whether or not the individual was placed out of home (1=yes, 0=0). Higher values indicate worse outcomes. Whether or not the child was placed out of home at the various timepoints will be assessed.
Caregiver mental health: Total Problems
BASELINE, 6 MONTHS, 12 MONTHS, 18 MONTHS
The Adult Self Report (ASR) is part of The Achenbach System of Empirically Based Assessment (ASEBA) that measures a broad range of behavioral, emotional, and social behaviors. The ABC is administered in interview format and respondents are asked to rate problem items as 0 for "not true," 1 for "somewhat or sometimes true," and 2 for "very true or often true", based on the past six months. The respondent for the ASR is the adult (self). The ASR consists of 126 items. The raw scores from the items are then compared with age- and gender-matched controls from the standardization sample, and standard scores are derived with a mean of 50 and a standard deviation of 10. Worst score is 80; best score is 30. Both change in mental health and overall mental health functioning at the various timepoints will be assessed.
Youth mental health: Child Behavior Checklist(CBCL/YSR), Total Problems
BASELINE, 6 MONTHS, 12 MONTHS, 18 MONTHS
The Child Child Behavior Checklist (CBCL)/ Adult Behavior Check List (ABCL)/Youth Self Report (YSR)/Adult Self Report (ASR) are part of The Achenbach System of Empirically Based Assessment (ASEBA) and measures behavioral, emotional, and social behaviors. Respondents rate problem items during the past 6 months as 0 for "not true," 1 for "somewhat or sometimes true," and 2 for "very true or often true". The respondent for the CBCL/ABCL is a caregiver. The CBCL is for youth aged 6-18 and the ABCL is for individuals aged 18-59. The respondent for the YSR/ASR are the youth/young adult reporting on him/herself. The CBCL has 113 items, the YSR has 112 items, and the ABCL is 123 items. The raw scores are compared with age- and gender-matched controls from a standardization sample; standard scores are derived (mean = 50, standard deviation = 10). Worst score is 80; best score is 30. Change in mental health and overall mental health functioning at the various timepoints will be assessed.
Caregiver mental/Behavioral health: Adaptive Functioning Scales: Personal Strengths
BASELINE, 6 MONTH, 12 MONTHS, 18 MONTHS
The Adult Self Report (ASR) is part of The Achenbach System of Empirically Based Assessment (ASEBA) that measures a broad range of behavioral, emotional, and social behaviors. The ABC is administered in interview format and respondents are asked to rate problem items as 0 for "not true," 1 for "somewhat or sometimes true," and 2 for "very true or often true", based on the past six months. The respondent for the ASR is the adult (self). The ASR consists of 126 items. The raw scores from the items are then compared with age- and gender-matched controls from the standardization sample, and standard scores are derived with a mean of 50 and a standard deviation of 10. Worst score is 80; best score is 30. Both change in mental health and overall mental health functioning at the various timepoints will be assessed.
Caregiver mental/Behavioral health: DSM-oriented scales-Avoidant Personality Problems
BASELINE, 6 MONTH, 12 MONTHS, 18 MONTHS
The Adult Self Report (ASR) is part of The Achenbach System of Empirically Based Assessment (ASEBA) that measures a broad range of behavioral, emotional, and social behaviors. The ABC is administered in interview format and respondents are asked to rate problem items as 0 for "not true," 1 for "somewhat or sometimes true," and 2 for "very true or often true", based on the past six months. The respondent for the ASR is the adult (self). The ASR consists of 126 items. The raw scores from the items are then compared with age- and gender-matched controls from the standardization sample, and standard scores are derived with a mean of 50 and a standard deviation of 10. Worst score is 80; best score is 30. Both change in mental health and overall mental health functioning at the various timepoints will be assessed.
Caregiver mental/Behavioral health: Syndrome Scales: Thought Problems
BASELINE, 6 MONTH, 12 MONTHS, 18 MONTHS
The Adult Self Report (ASR) is part of The Achenbach System of Empirically Based Assessment (ASEBA) that measures a broad range of behavioral, emotional, and social behaviors. The ABC is administered in interview format and respondents are asked to rate problem items as 0 for "not true," 1 for "somewhat or sometimes true," and 2 for "very true or often true", based on the past six months. The respondent for the ASR is the adult (self). The ASR consists of 126 items. The raw scores from the items are then compared with age- and gender-matched controls from the standardization sample, and standard scores are derived with a mean of 50 and a standard deviation of 10. Worst score is 80; best score is 30. Both change in mental health and overall mental health functioning at the various timepoints will be assessed.
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Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people get problem behavior a year in the United States?

It varied depending on the age and gender of a child (2–10 years old). [Children (12–35 years old)] were at the lowest rate of receiving problem behavior. [Men (5–9 years old)] and [children (2–4 years old)] were at the highest rate of receiving problem behavior. The gender differences were not apparent at ages 15–19 (11–13 years old). The number of boys receiving problem behavior surpassed that of girls at ages 15–19. However, there are no gender differences in the adolescent years. Boys are 4.6 times more likely to get problem behavior than girls.

Anonymous Patient Answer

Can problem behavior be cured?

Problem behavior is often a symptom of coexisting mental or physical difficulties. The current research suggests that, although problem behavior may not be an illness in itself, there is hope for cure. Research to explore how specific treatments can affect problem behavior and then generalize to treatments for broader illness syndromes of mental and physical dysfunction awaits further research.

Anonymous Patient Answer

What are the signs of problem behavior?

A combination of clinical and home observational data can identify children who are at risk for problem behavior and can support interventions. Findings from this study support that the development of problem behavior occurs over time and that child's age and internal and external parenting are the most significant predictors of problem behavior.

Anonymous Patient Answer

What are common treatments for problem behavior?

There are a wide array of treatments for problem behavior, including counseling, medication, and medical treatment. Although the research on these treatments is very limited and preliminary, it may be that behavioral treatment may be the safest and potentially best intervention for problem behavior, as opposed to a more direct medical treatment.

Anonymous Patient Answer

What causes problem behavior?

Recent findings show the importance of evaluating problem behavior, particularly regarding the occurrence of a problem in relation to the history of exposure to alcohol use.

Anonymous Patient Answer

What is problem behavior?

Given the impact of medical disorders on societal functioning, the question, 'What is problem behavior?', raises profound ethical issues. It is for this reason that these discussions have occurred in both medical and general practice. They are also relevant to all health care providers. If we define a problem behavior as any behavior that is a source of disability, illness, or stress that impacts on the well-being of another person, many forms of behavior have been identified. However, because of current societal expectations and the lack of adequate research, it has not necessarily been possible to quantify its prevalence, etiology, or consequences.

Anonymous Patient Answer

Does family centered treatment improve quality of life for those with problem behavior?

This family-based treatment resulted in significant improvement in caregiver quality of life. In addition to patient improvements that have been reported from studies in this approach, benefits have also been seen for children of caregivers who have participated in the treatment.

Anonymous Patient Answer

How serious can problem behavior be?

Children with problematic behavior in general are more than twice as likely to be hospitalized, more than three times as likely to be hospitalized for a mental health problem, and more than four times as likely to be hospitalized for a mood problem than children without aggressive behavior. A more aggressive approach to managing school problems may be in order, but school policies need to consider why problem behavior is an issue and how school intervention programs may have the greatest impact on school functioning.

Anonymous Patient Answer

Who should consider clinical trials for problem behavior?

The high rate of problem behavior at baseline in these patients did not predict a response to treatment or treatment failure. However, improvement at endpoint can be attained in all problem-elixirs, and therefore, clinical trials for problem-eliciting behavior should be encouraged in patients who are unable to stop these actions and may threaten their health and safety.

Anonymous Patient Answer

Has family centered treatment proven to be more effective than a placebo?

This is only preliminary research. The number of patients included in the study was not sufficient to adequately assess the likelihood of finding statistically significant results.

Anonymous Patient Answer

What is family centered treatment?

Results from a recent paper demonstrated the effectiveness of the family treatment approach in decreasing aggression in a group of boys with conduct disorder. Specifically, family treatment appeared to be most effective in decreasing anger, and this decrease was related to increases in family-centered positive relationships with teachers and peers within the group of boys. Findings suggest that the treatment must be ongoing and targeted to the individual in order to have long-term success. It may be important to work with a child to build the skills and knowledge necessary to maintain family treatment goals and help decrease aggressive behavior.

Anonymous Patient Answer

Have there been other clinical trials involving family centered treatment?

Previous research has shown that family centred therapies do produce positive effects, and family centred approaches are effective for managing adolescent behaviour problems. Other clinical studies including family centred approaches for patients with adolescent conduct problems are also in production. However there are no recent reports regarding family centred approaches with adolescents with chronic conditions who are struggling with substance abuse. Further studies with this clientele are urgently required to determine if family centred approaches are effective and acceptable.

Anonymous Patient Answer
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