Parental Control for Disruptive Behavior in Children

Overseen By Brian Greer, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Rutgers, The State University of New Jersey

Must be taking: Psychoactive drugs

Disqualifiers: Rett syndrome, Degenerative conditions, others

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

Compensation: Varies

Number of Visits: Unknown

30 Participants Needed

Trial Summary

What is the purpose of this trial?

Although behavioral treatments for decreasing destructive behavior, such as differential reinforcement of alternative behavior (DRA), are effective in the clinic, problem behavior often returns when a caregiver does not give the child their way in the natural environment (e.g., caregiver is busy with an infant sibling). This form of treatment relapse is known as resurgence. The goal of the current study is to evaluate whether alternating sessions in which the child can have their way (i.e., "on" sessions) with sessions in which the child can not have their way (i.e., "off" sessions) helps to mitigate resurgence.

Will I have to stop taking my current medications?

The trial requires that participants be on a stable medication regimen for at least 10 half-lives of each drug or be drug-free. This means you should not change your current medications before or during the trial.

What data supports the effectiveness of the treatment CDT for disruptive behavior in children?

The research suggests that combining parent training with medication can improve disruptive behavior in children, especially when negative parenting practices are reduced. This indicates that treatments involving parental involvement and medication, like CDT, may be effective. ^{1 2 3 4 5}

Is the treatment for disruptive behavior in children generally safe?

The research articles reviewed do not provide specific safety data for the treatment of disruptive behavior in children under the names CDT, Control, Placebo, or Standard Care. However, studies involving similar interventions, such as placebo treatments in children with conduct disorder and ADHD, suggest that these approaches are generally safe, with no significant adverse effects reported. ^{1 3 6 7 8}

How does the treatment CDT differ from other treatments for disruptive behavior in children?

The treatment CDT is unique because it involves parental control strategies, which focus on modifying the child's environment and behavior through non-drug methods, unlike other treatments that often rely on medication. This approach is particularly novel as there are no standard medications approved specifically for conduct disorder in children. ^{1 3 9 10 11}

Eligibility Criteria

This trial is for boys and girls aged 3 to 17 with disruptive behaviors, who experience problem behavior at least 10 times a day despite treatment. They must be on stable medication or drug-free, have consistent protective supports like helmets, and a steady educational plan. Those getting extensive current treatment or with conditions like Rett syndrome can't participate.

Inclusion Criteria

Problem behavior maintained by social positive reinforcement

Stable educational plan and placement with no anticipated changes during the child's treatment

I am between 3 and 17 years old.

Exclusion Criteria

Patients who do not meet the inclusion criteria

I have been diagnosed with Rett syndrome or a similar degenerative condition.

Patients currently receiving 15 or more hours per week of treatment for their problem behavior

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preliminary Procedures

Functional analysis and preference assessments are conducted to identify problem behavior and individualize conditions.

4-6 weeks

Multiple sessions (in-person)

DRA Evaluation

Evaluation of differential reinforcement of alternative behavior (DRA) to suppress problem behavior and increase functional communication response.

4-8 weeks

Multiple sessions (in-person)

Experiment 1

Participants undergo baseline and DRA phases, followed by a resurgence test to evaluate treatment relapse.

31 sessions for DRA, 10 sessions for resurgence test

Multiple sessions (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment.

4 weeks

Treatment Details

Interventions

• CDT
• Control

Trial Overview The study tests if alternating 'on' sessions where the child gets their way with 'off' sessions where they don't can reduce relapse of destructive behavior when caregivers are unavailable. It compares this approach (CDT) against standard control methods in managing aggression and self-harm.

Participant Groups

Group I: Contingency-Discrimintation Training (CDT) Experimental Treatment 1 Intervention

In this condition, the clinician will alternate sessions with reinforcement for the alternative response and sessions without reinforcement for the alternative response during extinction treatment of problem behavior. According to RaC2, alternating periods of reinforcer availability and unavailability for the alternative response will teach the participant that the alternative response alone produces reinforcement but not always. The investigators predict that resurgence of problem behavior will lower, shorter lasting, and with fewer participants experiencing resurgence than those in the control group.

Group II: Control Active Control 1 Intervention

This condition emulates a traditional approach to treatment in which the clinician does not alternate sessions with reinforcement for the alternative response and sessions without reinforcement for the alternative response during extinction treatment of problem behavior. The investigators predict that resurgence of problem behavior will higher, longer lasting, and with more participants experiencing resurgence than those in the CDT group.

Who Is Running the Clinical Trial?

Rutgers, The State University of New Jersey

Lead Sponsor

Trials

471

Recruited

81,700+

Findings from Research

In a study of 25 children aged 6 to 12 with conduct disorder, those who responded to placebo treatment had significantly higher detrimental psychosocial environmental scores, indicating they often came from more violent home environments.

Mild hyperactivity was linked to a poorer response to placebo, suggesting that certain behavioral traits may influence treatment outcomes in aggressive children with conduct disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Placebo response in aggressive children with conduct disorder. Sanchez, LE., Armenteros, JL., Small, AM., et al.[2009]

In a study involving 168 children aged 6-12 with severe aggression and ADHD, Augmented therapy (parent training, stimulant medication, and risperidone) was found to significantly reduce oppositional defiant disorder (ODD) severity and peer aggression compared to Basic therapy (parent training and stimulant medication).

Augmented therapy also led to a greater reduction in ADHD severity as rated by teachers, although both therapies showed that a significant number of children still experienced impairment from their symptoms, indicating that while improvements were noted, further intervention may be necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risperidone added to parent training and stimulant medication: effects on attention-deficit/hyperactivity disorder, oppositional defiant disorder, conduct disorder, and peer aggression. Gadow, KD., Arnold, LE., Molina, BS., et al.[2022]

In a double-blind randomized controlled trial involving 151 children aged 6-12 with ADHD and aggressive behaviors, 63.6% achieved remission after optimizing psychostimulant treatment, highlighting the importance of initial treatment adjustments before considering additional medications.

Only 40 participants were eligible for the main analysis comparing risperidone, valproex sodium, and placebo, indicating that the study's findings may be limited due to the small sample size, but it emphasizes the need for clinicians to focus on optimizing existing treatments before adding new ones.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Editorial: Why JAACAP Published an "Inconclusive" Trial: Optimize, Optimize, Optimize Psychostimulant Treatment. Cortese, S., Novins, DK.[2021]

The MATCH intervention demonstrated faster improvements in youth with severe irritability compared to standard manualized treatments (SMT) and usual care (UC), with medium to large effect sizes in two-thirds of comparisons, indicating its effectiveness.

Youth receiving MATCH had significantly fewer posttreatment diagnoses of irritability compared to those in UC, averaging 1.0 fewer diagnoses, suggesting that this modular approach may be particularly beneficial for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of standard and modular psychotherapies in the treatment of youth with severe irritability. Evans, SC., Weisz, JR., Carvalho, AC., et al.[2020]

In a study of 579 children with ADHD, reductions in negative and ineffective parenting practices were linked to improved social skills and reduced disruptive behavior, particularly in those receiving combination treatment of medication and behavioral therapy.

The combination treatment was more effective than behavioral treatment alone, suggesting that addressing parenting practices can enhance the therapeutic outcomes for children with ADHD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Family processes and treatment outcome in the MTA: negative/ineffective parenting practices in relation to multimodal treatment. Hinshaw, SP., Owens, EB., Wells, KC., et al.[2022]

In a study involving eight children with autism, dextromethorphan, a glutamate antagonist, showed no significant difference in reducing problematic behaviors compared to a placebo, indicating limited efficacy for the overall group.

However, individual analyses revealed that three participants, particularly those with ADHD-like behaviors, responded positively to dextromethorphan, suggesting that it may be beneficial for a specific subset of children with autism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A placebo double-blind pilot study of dextromethorphan for problematic behaviors in children with autism. Woodard, C., Groden, J., Goodwin, M., et al.[2013]

Methylphenidate significantly reduces hyperactive, disruptive, and aggressive behaviors in children with ADHD and tic disorder, with noticeable effects even at the lowest dose of 0.1 mg/kg.

While there was a slight increase in motor tics at the 0.1 mg/kg dose, this was not considered clinically significant by caregivers, indicating that methylphenidate is generally safe for managing ADHD symptoms without worsening tic severity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

School observations of children with attention-deficit hyperactivity disorder and comorbid tic disorder: effects of methylphenidate treatment. Gadow, KD., Nolan, E., Sprafkin, J., et al.[2013]

Central nervous system stimulants, either alone or combined with behavior therapy, are effective in reducing irritability in children and adolescents with ADHD, especially those with comorbid conditions like disruptive mood dysregulation disorder.

There is limited evidence supporting the effectiveness of guanfacine and atomoxetine for reducing irritability in youth with ADHD, particularly those with autism spectrum disorder, highlighting the need for further research on psychosocial interventions like cognitive behavioral therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Mini-Review of Pharmacological and Psychosocial Interventions for Reducing Irritability Among Youth With ADHD. Breaux, R., Dunn, NC., Swanson, CS., et al.[2022]

Children and adolescents with conduct disorder (CD) present a significant challenge for treatment, as no medications have been formally approved for this condition in the US or Europe, despite various pharmacological interventions being explored.

The review highlights the need for more effective evidence-based pharmacotherapy for CD, addressing both efficacy and adverse effects from clinical trials, and suggests future directions for improving treatment options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychopharmacology of conduct disorder: current progress and future directions. Tcheremissine, OV., Cherek, DR., Lane, SD.[2019]

In a study of 44 hospitalized children with conduct disorder, 52.3% showed improvement in aggression during a 2-week placebo lead-in period, suggesting that hospitalization itself can have beneficial effects without immediate medication.

The results indicate that starting medication right away may not be necessary, as improvements could be due to the structured hospital environment or placebo effects, highlighting the importance of a placebo baseline in research to avoid misattributing benefits to pharmacotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nonpharmacological response in hospitalized children with conduct disorder. Malone, RP., Luebbert, JF., Delaney, MA., et al.[2007]

In a study of 125 ADHD patients aged 6-12, atomoxetine significantly reduced ADHD symptoms as measured by a computer-based continuous performance test and motion tracking, regardless of the presence of comorbid oppositional defiant disorder (ODD) or conduct disorder (CD).

The treatment effect of atomoxetine was notably stronger in patients with comorbid ODD/CD, indicating that it may be particularly effective for this subgroup in managing hyperactivity symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does Comorbid Disruptive Behavior Modify the Effects of Atomoxetine on ADHD Symptoms as Measured by a Continuous Performance Test and a Motion Tracking Device? Wehmeier, PM., Kipp, L., Banaschewski, T., et al.[2022]

References

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

Placebo response in aggressive children with conduct disorder. [2009]

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

Risperidone added to parent training and stimulant medication: effects on attention-deficit/hyperactivity disorder, oppositional defiant disorder, conduct disorder, and peer aggression. [2022]

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

Editorial: Why JAACAP Published an "Inconclusive" Trial: Optimize, Optimize, Optimize Psychostimulant Treatment. [2021]

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

Effects of standard and modular psychotherapies in the treatment of youth with severe irritability. [2020]

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

Family processes and treatment outcome in the MTA: negative/ineffective parenting practices in relation to multimodal treatment. [2022]

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

A placebo double-blind pilot study of dextromethorphan for problematic behaviors in children with autism. [2013]

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

School observations of children with attention-deficit hyperactivity disorder and comorbid tic disorder: effects of methylphenidate treatment. [2013]

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

A Mini-Review of Pharmacological and Psychosocial Interventions for Reducing Irritability Among Youth With ADHD. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Psychopharmacology of conduct disorder: current progress and future directions. [2019]

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

Nonpharmacological response in hospitalized children with conduct disorder. [2007]

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

Does Comorbid Disruptive Behavior Modify the Effects of Atomoxetine on ADHD Symptoms as Measured by a Continuous Performance Test and a Motion Tracking Device? [2022]