RecruitingACTRN12621001027808

Collaborative and Proactive Solutions for irritability in children and adolescents

Can a psychological intervention reduce irritability in children and adolescents more than usual care? A randomised-controlled trial

Sponsor

Melissa Mulraney

Enrollment

160 participants

Start Date

Oct 19, 2021

Study Type

Interventional

Conditions

Irritability

Summary

Irritability is a highly prevalent, transdiagnostic symptom present in many commonly diagnosed child mental health disorders that confers risk for future anxiety, depression, and suicidality. Approximately 30-50% of children referred to mental health services experience severe irritability and irritable children place a high burden on the healthcare system with up to 15 times more service usage than children with mental health problems who are not experiencing irritability. There are currently no evidence-based treatments available that effectively reduce irritability and associated impairments. We will conduct a randomised controlled trial to test the efficacy of a psychological intervention, Collaborative and Proactive Solutions, for irritability in children and adolescents aged 5-15 years compared with usual care in terms of reducing irritability, and improving broader child and family wellbeing. Children referred to outpatient and community mental health services will be assessed for clinically significant irritability. Eligible children will be randomised to the CPS intervention (n=80) (8 sessions over 10 weeks) or usual clinical care from the mental health service (n=80). All participants will be assessed 4 and 12 months post-randomisation.

Eligibility

Sex: Both males and femalesMin Age: 5 YearssMax Age: 15 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing a psychological intervention called Collaborative and Proactive Solutions (CPS) for children and adolescents aged 5 to 15 who experience severe, persistent irritability. Chronic irritability — going beyond typical childhood frustration to include explosive temper outbursts, chronic grumpiness, and difficulty tolerating minor frustrations — is one of the most common reasons children are referred to mental health services and is associated with future depression, anxiety, and difficulties at school and home. CPS is a structured, problem-solving approach that involves parents working collaboratively with the child to identify what triggers their irritability and find solutions together — rather than using reward-and-consequence discipline systems. Children will be randomised to receive eight CPS sessions over 10 weeks or to continue receiving usual mental health care. Outcomes including irritability levels, child and family wellbeing, and broader behavioural and emotional difficulties will be assessed at 4 and 12 months. To be eligible, the child must be aged 5 to 15 and score 3 or higher on the parent-rated Affective Reactivity Index (a brief measure of irritability). Children with intellectual disability, psychotic disorders, or who cannot communicate in English are not eligible. The study is run by Melissa Mulraney and collaborators.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

The intervention is a psychological therapy called Collaborative & Proactive Solutions. It will be delivered by study trained clinicians. The intervention comprises 8x1 hour sessions once a week for six weeks and then once every two weeks for the final 2 sessions (total of 8 sessions over 10 weeks). The intervention is administered face-to-face, or via telehealth, with the child and parent/s. Sessions can include time with the parent/s alone, with the child alone, and with both the child and parent/s present. The structure of the intervention is as follows: (a) Identification of lagging skills and unsolved problems that contribute to temper outbursts, and a discussion of how existing parental responses may be counterproductive; (b) Prioritization—helping parents prioritize which unsolved problems will be the focal point of initial problem-solving discussions; (c) Introduction of the Plans framework— helping parents understand the three potential responses to solving problems: Plan A (solving a problem unilaterally, through imposition of adult will and often accompanied by adult-imposed consequences), Plan B (solving a problem collaboratively and proactively), and Plan C (setting aside the problem for now); and (d) Implementing Plan B—helping parents and children become proficient in the use of Plan B and largely discontinuing the use of Plan A. Although the clinician actively guides the problem-solving process initially, the goal of treatment is to help the child and parents become increasingly independent in solving problems together. Clinicians will complete a Clinical Record Form (CRF) for each session to document adherence to intervention protocols.