A Randomized Controlled Trial on Brief Behavioral Parent Training

1. INTRODUCTION AND RATIONALE

Behavioral difficulties, including oppositional, defiant, aggressive, hyperactive, impulsive, and inattentive behavior, are one of the most common reasons for referral to mental healthcare among children and adolescents (Antshel, 2015; Polanczyk et al., 2015). When left untreated, problems may exacerbate and put children at risk of adverse outcomes later on in life, such as school dropout, delinquency, substance use and depression (Franke et al., 2018; Reef et al., 2011). Ideally, treatment should prevent this escalation of problems, reduce the need for long and intensive treatments, and lower societal costs (Drummond et al., 2015).

Behavioral parent training is the first psychosocial treatment of choice for reducing behavioral difficulties in preschool and school aged children (Akwa GGZ, 2019; Brestan \& Eyberg, 1998; Eyberg et al., 2008; Kaminski \& Claussen, 2017; National Institute for Health and Care Excellence \[NICE\], 2017; National Institute for Health and Care Excellence \[NICE\], 2019; Nederlandse Vereniging voor Psychiatrie, 2013). However, its use in clinical practice is limited by a scarcity of certified therapists, long waiting lists, and the typically long and sometimes perceived as rigid nature of behavioral parent training programs, which may lead to parents not starting or finishing behavioral parent training (Chacko et al., 2016; Evans et al., 2018; Weisenmuller \& Hilton, 2021).

To reduce these barriers, this study evaluates a brief and individually tailored behavioral parent training program for children with behavioral difficulties (the "PAINT-GGZ" program, developed by the Psychosocial ADHD \& disruptive behavior INTerventions \[PAINT\] consortium). The brief training includes optional booster sessions for families who need additional support. The trial will generate knowledge on the (cost)effectiveness of brief parent training with optional booster sessions for children with behavioral difficulties. Brief programs are scarce, mostly do not provide booster sessions, and are mainly evaluated in prevention settings (Kolko \& Lindheim, 2014; Tully \& Hunt, 2015). This project fills these knowledge gaps. 2. OBJECTIVES

The first objective of this study is to examine the short- and longer-term (i.e., one year) effectiveness of the brief and individually tailored behavioral parent training program with optional booster sessions compared to care as usual (CAU) on daily measured child behavioral difficulties (primary outcome) and on a range of secondary outcomes (see Outcomes). Additionally, we will explore whether a number of general demographic and clinical characteristics, parental attachment, parental psychopathology, parental reward responsivity, and reward and punishment sensitivity of the child moderate the short- and longer-term intervention effects on our primary outcome. The second objective is to investigate the cost-effectiveness of the program compared to CAU. As we assess cost-effectiveness based on measures at baseline and one year after the intervention, we can only draw conclusions about the cost-effectiveness on the longer term. 3. STUDY DESIGN AND SETTING

In this two-arm multi-center randomized controlled trial, parents of children who experience behavioral difficulties in the home setting and were referred to a child mental healthcare center, are randomly assigned (1:1 ratio) to either (a) three sessions of brief behavioral parent training with optional booster sessions, or (b) CAU, as regularly provided by the involved mental healthcare centers. There are no restrictions regarding the type (e.g., psychoeducation, parent counseling and support, individual child therapy, medication) or duration of CAU, only the brief parent training investigated in this trial is not allowed. Both parents and children in the brief behavioral parent training group are not allowed to receive CAU until the first posttreatment assessment (T1). After that, CAU is allowed and parents can also make use of booster sessions with the therapist who provided the training.

To ensure our findings reflect the real-world impact of brief behavioral parent training (i.e., to test effectiveness rather than efficacy), the trial is fully embedded in routine mental healthcare. The participating centers are academic and non-academic youth mental healthcare centers of various sizes. Therapists who provide the brief behavioral parent training have a master's degree in psychology or child, family and education studies and have had postmaster education in cognitive behavioral therapy (at least 50 hours) or have a registered higher vocational education degree as social worker in cognitive behavioral therapy. The therapists are trained in the brief parent training by supervisors qualified in cognitive behavior therapy during a one-day training of seven hours, in which therapists practice the parent training by roleplay and evaluate on their performance. Therapists also receive weekly supervision by these qualified supervisors when providing the brief parent training. Additionally, the supervisors provide feedback to each therapist on the audio-taped first session regarding protocol fidelity, intervention integrity, and the process of providing the training (e.g., engaging parents, didactic skills). There are no in- or exclusion criteria for clinicians in the CAU condition. To prevent contamination of the two research arms, therapists never provide both the brief behavioral parent training and CAU to parents participating in this study and are instructed not to share information about the contents of the brief training. 4. TIME FRAME

Year 1: start recruitment, screening and inclusion of parents and children, start running interventions Years 2-4: ongoing contacts with mental health care organizations; recruitment, screening, and inclusion of children; run interventions and conduct measurements; supervision of therapists; fidelity checks; other project management activities; data-analysis. The last inclusion of patients is planned in year 4.

Year 5: further data-analysis, dissemination of results, implementation activities.

For this trial we have installed a parent advisory board (four members, one of them represents "Balans", a Dutch association for parents of children with developmental problems). The board is involved in this trial since the grant application. They provided feedback and ideas for the current project and meet biannually in the first and last year of the project and annually in years two, three, and four. In the last year, they will be asked to give their ideas about the interpretation of the results. The members of the board receive reimbursements for all meetings. 5. STUDY POPULATION

The sample will consist of parents of children (2-12) with behavioral difficulties who have been referred to one of the participating Dutch mental healthcare centers. Based on our previous study that found medium-sized short term effects on daily ratings of behavioral difficulties compared to waitlist (range of Cohen's d = .35 to d = .66, Hornstra et al., 2021) and studies showing medium-sized parenting intervention effects on behavioral difficulties using parent-report rating scales (Bakker et al., 2017; Daley et al., 2014; McCart et al., 2006; Van Aar et al., 2017; Van den Hoofdakker et al., 2007), we estimate the effect of our brief behavioral parent training program as compared to CAU to be at least small (d = .25).

A power analysis has been performed using G\*Power software (Faul et al., 2007). Based on an effect size of d = .25 (f = .125), two groups and three repeated measures (T0, T1, T2 for short term effectiveness), with r = .60 between-measurement relation, a power of .80 and α = 0.05, we need at least 42 participants per group, resulting in a total of 84 participants. Given that the data are clustered, we increased the sample size with 10% (Twisk, 2010), resulting in a total of 93 participants. This is in line with the number of participants in similar studies comparing behavioral treatments to CAU (e.g., Van den Hoofdakker et al., 2007). 6. TREATMENT OF SUBJECTS

During a period of one year, parents in the parent training condition will participate in a brief three-session parent training program with optional additional booster sessions and/or CAU after the parent training. The first two sessions will take 120 minutes and the third session will take one hour. These three sessions will be planned in three to four consecutive weeks. In between sessions, parents are asked to read some materials and practice the behavioral techniques they have learned with their child at home. After the brief parent training program, care as usual and/or additional booster sessions can be requested if deemed necessary by the parents or therapist. The additional booster sessions will take one hour each and can be requested maximally once every four weeks up to one year after the brief parent training program.

The individual, three-session parent training program uses the behavioral techniques that were identified as effective for behavioral difficulties in our microtrial (Hornstra et al., 2021) and the broader literature (Kaminski et al., 2008; Leijten et al., 2019; Leijten et al., 2021). The program combines the stimulus control and contingency management techniques that, separately, reduced behavioral difficulties in the previous microtrial. Importantly, using functional analyses, the techniques are tailored to the specific problem behaviors that individual parents experience with their child. This individualized approach perfectly fits with the advice of our parent advisory board, that indicated that targeting individual parental needs is crucial for parents. To prevent relapse and reduce the need for more intensive treatments (including psychotropic medication, such as methylphenidate or antipsychotics), a booster session on maintenance training can be added at several time points (maximum once every four weeks) for parents wishing to receive additional support. Our parent advisory board considered the optional booster sessions as very important and helpful, as some parents may experience relinquishing of their parenting skills after finishing parent training, for example in stressful times (see also Furlong \& McGilloway, 2014).

Parents in the control condition will receive care as usual, which in Dutch mental health care typically consists of psychoeducation, parent counseling and support, medication, (longer) parent training programs, family therapy, and/or cognitive behavior therapy or other therapy for the child. The load imposed on these parents depends on the type of care they and/or their child receive. This usual care will also be provided to parents who do not participate in this study. The treatment in the control condition does therefore not impose any additional load compared to not participating in this study. 7. METHODS

Parents will provide information on children's age and gender, on their own and children's ethnicity, educational background, and household composition, and on children's previous and ongoing pharmacological and non-pharmacological treatments, medical conditions, and clinical diagnoses (e.g., ADHD, oppositional defiant disorder \[ODD\], conduct disorder \[CD\]).

PRIMARY AND SECONDARY STUDY PARAMETERS

The primary outcome of the study is the severity of four individual target behavioral difficulties that parents want to address in the training. The secondary outcomes of the study are parent-reported behavioral difficulties, parent-reported child well-being, parent-reported parenting behaviors, masked audio records of mealtime routines to measure parent and child behavior, parent-reported parenting stress, parent-reported parenting self-efficacy, parent-reported quality of the parent-child relation, consumption and costs of mental health care and health state utility

• Change in parent-reported behavioral difficulties [Срок оценки: A week before T0, one week after the brief training/eight weeks after T0 (T1), six months after T1 (T2), twelve months after T1 (T3), during and two weeks after each booster session for parents who receive the brief parent training.]
• Change in child well-being [Срок оценки: Before the brief training/before any intervention (T0), one week after the brief training/eight weeks after T0 (T1), six months after T1 (T2), and twelve months after T1 (T3)]
• Change in parenting behaviors [Срок оценки: Before the brief training/before any intervention (T0), one week after the brief training/eight weeks after T0 (T1), six months after T1 (T2), and twelve months after T1 (T3)]
• Change in observed parent and child behaviors (audiotapes - masked measure) [Срок оценки: Before the brief training/before any intervention (T0), one week after the brief training/eight weeks after T0 (T1), and twelve months after T1 (T3)]
• Change in parenting stress [Срок оценки: Before the brief training/before any intervention (T0), one week after the brief training/eight weeks after T0 (T1), six months after T1 (T2), and twelve months after T1 (T3)]
• Change in parenting self-efficacy [Срок оценки: Before the brief training/before any intervention (T0), one week after the brief training/eight weeks after T0 (T1), six months after T1 (T2), and twelve months after T1 (T3)]
• Change in quality of the parent-child relation [Срок оценки: Before the brief training/before any intervention (T0), one week after the brief training/eight weeks after T0 (T1), six months after T1 (T2), and twelve months after T1 (T3)]
• Evaluations of the program by parents - Questionnaire [Срок оценки: One week after the brief training/eight weeks after T0 (T1) and twelve months after T1 (T3) for parents who receive the brief parent training.]
• Evaluations of the program by parents - Focus Groups [Срок оценки: After the inclusion of participants in the trial is finished, which is anticipated to be at the beginning of 2025.]
• Evaluations of the program by therapists - Questionnaire [Срок оценки: After the trial is finished, which is anticipated to be at the beginning of 2026.]
• Evaluations of the program by therapists - Focus Groups [Срок оценки: After the trial is finished, which is anticipated to be at the beginning of 2026.]
• Change in use of health care [Срок оценки: Before the brief training/before any intervention (T0) and twelve months after T1 (T3).]