Augmenting Parent Management Training for Child Temper Outbursts Using a Digital Tool

Study Description:

This study is a feasibility study (N=60 parent-child dyads) of a digital tool (machine learning and a smartphone application) augmenting parent management training (PMT) to support the reduction of irritability and temper outbursts through changes in parenting behaviors (i.e., active ignoring) for pediatric disruptive behavior disorders (DBDs). We examine the feasibility of the study design (i.e., two-arm randomized controlled trial [RCT] of PMT + ecological momentary assessment [EMA] + digital tool vs. PMT + EMA + no digital tool) and examine patterns of change in irritability, outbursts, and parenting behaviors (i.e., active ignoring).

Objectives:

Primary Objective: Determine the feasibility of the design of a clinical trial (i.e., RCT with two parallel arms - PMT + EMA + digital tool compared to PMT + EMA + no digital tool).

Secondary Objective:

• Determine whether outbursts and irritability decrease in PMT + EMA + digital tool and PMT + EMA + no digital tool. Determine whether severity of impairment decreases and general functioning improves in both groups.
• Determine whether active ignoring increases in PMT + EMA + digital tool and PMT + EMA + no digital tool.

Tertiary Objective:

• Examine whether attention deficit/hyperactivity disorder (ADHD), anxiety, and depression symptoms decrease in PMT + EMA + digital tool and PMT + EMA + no digital tool.
• Monitor treatment acceptability and fidelity and therapeutic support.

Endpoints:

Primary Endpoint:

Dropout in each arm of the trial (PMT + EMA + digital tool vs. PMT + EMA + no digital tool).

Secondary Endpoint:

• Changes in child outbursts and irritability measured using the Clinician-rated Affective Reactivity Index (CLARI); parent-/child-ARI; Brief Irritability Test (BITe); and parent/child EMA (collected 3x/day from baseline through 3 months post-treatment). Changes in severity of impairment and general functioning using the Children s Global Assessment Scale (CGAS), Clinical Global Impressions Scale-Severity (CGI-S), and Clinical Global Impress Scale-Improvement (CGI-I).
• Changes in active ignoring measured using parent EMA (collected 3x/day from baseline through 3 months post-treatment).

Tertiary Endpoint:

• Changes in symptoms of ADHD, anxiety, and depression. ADHD is measured using the ADHD Rating Scale (ADHD-RS) and Conners Parent Rating Scale (CPRS-R). Anxiety is measured using the Screen for Child Anxiety Related Disorders (SCARED) and Pediatric Anxiety Rating Scale (PARS). Depression is measured using the Mood and Feelings Questionnaire (MFQ) and Child Depression Rating Scale (CDRS).
• We will monitor treatment acceptability using the Working Alliance Inventory (WAI) and treatment fidelity using an adherence scale previously developed by our group.

• INCLUSION CRITERIA:

Inclusion criteria

for Youth:

To be eligible to participate, an individual must be enrolled in the 01-M-0254 protocol. All screening will occur under 01-M-0254 and all inclusion criteria for youth and parent or guardian will be determined under the 01-M-0254 protocol. To be eligible to participate, an individual must meet all the following criteria:

• Enrollment into protocol 01-M-0254 for screening purposes
• Age 8-13 years (8 years 0 months through 13 years 11 months)
• Parent/guardian and/or child reports irritability as a primary clinical concern. Specifically, compared to his/her peers, the child exhibits markedly increased reactivity to negative emotional stimuli that is manifest verbally or behaviorally. For example, the child responds to frustration with extended temper tantrums (inappropriate for age and/or precipitating event), verbal rages, and/or aggression toward people or property. This criterion is assessed based on the clinical interview conducted with parent/guardian and child after consenting into protocol 01-M-0254 for screening.
• On the basis of record review and interviews with child and parent or guardian, the research team agrees that the child s response to his/her current treatment is no more than minimal (i.e., CGI-S of 3 or more). This criterion is assessed based on the clinical interview conducted with parent/guardian and child after consenting into protocol 01-M-0254 for screening.
• Patients must be fluent in (speaking, reading) English after consenting into protocol 01-M-0254 as determined through clinical judgement.

--This study uses English-language manualized PMT. The PMT intervention materials, digital tool, therapist and rater training and supervision procedures, fidelity ratings, and outcome measures are currently available and validated only in English. Because psychotherapy relies on nuanced verbal exchange, use of translation or interpreters could alter treatment content, affect therapeutic alliance, compromise fidelity, and limit accurate clinical risk assessment. Enrolling non-English speakers can introduce a confound to our research objectives around feasibility, symptom and behavior change, and acceptability and fidelity. Restricting enrollment to English-speaking participants is therefore necessary to ensure participant safety and scientific validity in this trial. Critically, this eligibility criterion is based solely on the language requirements of the intervention and study procedures and is not intended to exclude participants on the basis of race or ethnicity or any other factors.

• At least one parent or guardian of the minor subject must be willing to enroll in the protocol and have the cognitive ability to consent.
• The minor subject must be able understand a written assent document as determined through clinical judgement, as well as be willing to sign a written assent document.

Inclusion criteria

for Parent or Guardian:

To be eligible to participate, an individual must be enrolled in the 01-M-0254 protocol. All screening will occur under 01-M-0254 and all inclusion criteria for youth and parent or guardian will be determined under the 01-M-0254 protocol. To be eligible to participate, an individual must meet all the following criteria:

• Enrollment into 01-M-0254 for screening purposes
• Parent or guardian of a child eligible for this protocol that can attend 12 PMT sessions and is willing to use the digital tool
• Fluent in English after consenting into protocol 01-M-0254 as determined through clinical judgement
• Ability of parent or guardian to understand the consent form and the willingness to sign a written informed consent document

Exclusion criteria

Exclusion criteria

for Youth:

All screening will occur under 01-M-0254 and all exclusion criteria for youth and parent or guardian will be determined under the 01-M-0254 protocol. Participants will be screened to exclude participants who would not be able to engage in psychotherapy. All individuals meeting any of the exclusion criteria at baseline will be excluded from participation.

• Active major depressive disorder or history of psychosis, bipolar I disorder, Level 2 or 3 autism spectrum disorder, active severe substance use disorders (within the last month), have active suicidal intent or plan as detected on screening instruments
• IQ < 70
• Past or present medical or neurological condition, disease, disorder, genetic finding, or injury that, in the opinion of the Investigator, may significantly increase the potential risks of study participation, reduce or compromise a subject s ability to fully comply with all study requirements for the duration of the study or may compromise the integrity of the data.

Exclusion criteria

for Parent or Guardian:

All screening will occur under 01-M-0254 and all exclusion criteria for youth and parent or guardian will be determined under the 01-M-0254 protocol. Participants will be screened to exclude participants who would not be able to engage in psychotherapy. All individuals meeting any of the exclusion criteria at baseline will be excluded from participation.

• IQ < 70 as assessed via a neuropsychological assessment or via assessment by trained clinical staff
• Have any serious medical, mental health, or any condition that interferes with participation, such as active psychosis.
• Current alcohol or substance use or dependence (excluding nicotine) within the past 3 months of sufficient magnitude to require independent, concurrent treatment intervention (e.g., antabuse or opiate treatment but not including self-help groups).