PAINT-P: Brief Parent Training
Study Details
Study Description
Brief Summary
RATIONALE
Problems of children with disruptive (i.e., oppositional, impulsive, hyperactive, and aggressive) behaviors often grow into chronic disorders and subsequent adverse outcomes, such as school drop-out, delinquency, substance use, anti-social personality disorder, and depression. Ideally, treatment should prevent the escalation of problems, reduce the need for long and intensive or potentially harmful treatments (such as antipsychotics), and lower societal costs. Parent training has a strong effect on disruptive behaviors, however, only few families receive empirically-supported parent training. Programs are typically long and waiting lists are therefore common. Also, most existing interventions are not tailored to individual parental needs. There is thus an urgent need for brief, accessible, and individually-tailored programs.
OBJECTIVES
This project aims to increase the effective use of parent training for children with disruptive behaviors by (1) examining short and long-term effectiveness of a new, brief, individual, and individually-tailored parent training program with optional booster sessions to prevent relapse, compared to care as usual (CAU) in a randomized controlled trial; (2) assessing the cost-effectiveness of the brief parent training program compared to CAU.
STUDY DESIGN
A randomized controlled trial (RCT) with two arms will be used. Referred children and their parents will be randomly assigned (equal randomization) to (a) three sessions of brief parent training, with optional single booster sessions up to one year after the training, or (b) CAU, as regularly provided by the mental health centers involved. The study outcomes will be measured at baseline before the brief training (T0), one week after the brief training (T1), six months after T1 (T2), and twelve months after T1 (T3). For parents in the control condition, similar measurement time points will be used: before any intervention (T0), eight weeks after T0 (T1), six months after T1 (T2), and twelve months after T1 (T3).
STUDY POPULATION
Children with disruptive behaviors that have been referred at one of five Dutch mental health centers.
INTERVENTION
Parents in the intervention arm will receive a short, individualized, three-session training primarily aimed at reducing children's disruptive behaviors. It exists of two (bi)weekly individually tailored training sessions of two hours and a third session of one hour in which the training will be evaluated, and maintenance training will be provided. After that, parents wishing to receive additional support can receive single booster sessions maximum once every four weeks and/or receive care as usual. Parents in the control arm will receive care as usual for children's disruptive behavior. The treatments in both arms will be fully embedded in Dutch routine mental health care.
MAIN STUDY PARAMETERS
Primary outcomes will be the severity of four individual target disruptive behaviors that parents want to address in the training and parent-reported disruptive behaviors on the Intensity scale of the Eyberg Child Behavior Inventory (ECBI-I). Secondary outcomes will be 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 parental attitude towards their child, consumption and cost of mental health care, and health state utility values. We will furthermore measure evaluations of the program by parents and therapists and explore whether parental attachment, parental psychopathology, parental reward responsivity, parent-reported child reward responsivity and punishment sensitivity moderate the intervention effects.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
- INTRODUCTION AND RATIONALE
Disruptive behaviors, such as oppositional, hyperactive, impulsive, and aggressive behaviors, are highly prevalent in children and adolescents and one of the most common reasons for referral to mental health care. When left untreated, problems often exacerbate, grow into disorders and put children at risk of subsequent adverse outcomes, such as school dropout, delinquency, substance use, anti-social personality disorder, and depression (Franke et al., 2018; Reef et al., 2010). Ideally, treatment should prevent the escalation of problems, reduce the need for long and intensive treatments (including antipsychotics or other medication), and lower societal costs (Drummond et al., 2015).
Parent-focused behavioral (i.e., social learning theory based) training programs have strong effects on disruptive behaviors in childhood (Bakker et al., 2016; Kaminski & Claussen 2017; McCart et al., 2006), probably because parents can curtail the development of disruptive child behavior (e.g., by avoiding or breaking coercive parent-child interactions (McMahon & Forehand, 2019). Yet, our understanding of longer-term effects of parent training is limited and relapse is common in clinical practice. Besides this, two other problems undermine the effective use of parenting interventions. First, only few families actually receive empirically-supported parent training. Programs are typically long and often require certified therapists, who are scarce. Waiting lists are therefore common. Also, most programs are not tailored to the individual needs of parents. These barriers may lead to parents not starting or completing parent training (Weisenmuller & Hilton, 2021). There is thus an urgent need for brief, accessible, and individually-tailored programs, designed to yield sustained effects.
To address this need, we will evaluate a brief, individual, and individually-tailored parent training program based on the effective intervention elements identified in our earlier work (Dekkers et al., 2022; Hornstra et al., 2021). The program can be easily implemented in clinical practice, as therapists have to be trained only briefly and do not need to be highly qualified, and the intervention consists of only three sessions. Our previous project (Hornstra et al., 2021) showed that the magnitude of effects of a brief program was similar to those of traditional, long programs (i.e., two sessions focusing on key elements yielded similar effects as traditional parent training programs (Dekkers et al., 2022). Importantly, (1) the dropout rate was much lower than those of traditional programs; (2) sessions were easy to provide for clinicians; (3) parents were easily motivated to receive the intervention; and (4) satisfaction of parents and therapists was high. Parents were particularly positive about the short time span of the training and the program's focus on tailoring program content to the individual problems parents experience. To prevent relapse and possible use of other, more intensive and expensive treatments, parents can receive booster sessions in the first year after the brief training.
The trial will generate knowledge on the (cost)effectiveness of brief parent training with optional booster sessions for children with disruptive behaviors. 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.
- OBJECTIVES
Primary Objective: To examine the short- and long-term effectiveness of a brief and individually-tailored behavioral parent training program with optional booster sessions, compared to care as usual (CAU).
Secondary Objective(s): To investigate the cost-effectiveness of the brief parent training program, compared to CAU.
- STUDY DESIGN
We will conduct a two-armed randomized controlled trial. Referred children and their parents will be randomly assigned (equal randomization) to (a) three sessions of brief parent training, with optional booster sessions up to one year after the brief training, or (b) care as usual (CAU), as regularly provided by the mental health centers involved. There will be no restrictions regarding the type or duration of CAU (only the brief parent training will not be allowed) which may for example include psychoeducation, (long) parent training, child treatment (e.g., pharmacotherapy, cognitive behavioral therapy) or family therapy. Children in the brief parent training group will not receive CAU until the first posttreatment assessment (T1). After that, CAU is allowed and parents can repeatedly (maximum once every four weeks) make use of booster sessions with the therapist who provided the training. By comparing our intervention against CAU, we stringently test whether the brief intervention outperforms to the services families currently receive.
To ensure our findings reflect the real-world impact of the brief parent training (i.e., to test effectiveness rather than efficacy), we will fully embed the trial in Dutch routine mental health care. This will also allow us to generalize our findings to the large number of children with disruptive behaviors that are currently referred to mental health care facilities. The participating mental health care centers will be Accare (Groningen), Levvel (Amsterdam), UvA Minds (Amsterdam), Dokter Bosman (Amsterdam), and Psychologenpraktijk Kuin (Haarlem). Therapists who will provide the brief parent training will be psychologists with a Masters in Psychology/Orthopedagogy and postmaster education on behavioral therapy from the participating centers (in Dutch: basiscursus CGT) or be qualified as a cognitive behavioral therapist (in Dutch: CGW'er). All other clinicians from the participating centers can be involved in providing the care as usual. Type, frequencies, and duration of booster sessions and CAU will be tracked to be able to compare cost-effectiveness between arms.
To assess the cost-effectiveness, the costs involved in the health of participants who receive the brief parent training with optional booster sessions (e.g., mental health care, medication, educational needs, absence/ inability to work) will be compared to the costs involved in the health of participants who receive CAU. To properly assess cost-effectiveness and prevent the risk for deterioration that can result from being placed on a waitlist for treatment, families in the brief parent training condition will start with the brief parent training immediately after their assessment, before any other treatment (e.g., medication) has started.
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 the trial we have installed a parent advisory board (four members, one of them represents Parent Association for parents of children with disruptive behavioral problems and ADHD "Balans"). The board provided feedback and ideas for the current project and will meet bi-yearly in the first and last year of the project and yearly in years two, three, and four to discuss the setup of the studies (e.g., communication towards parents), and results. They will receive reimbursements for all meetings.
- STUDY POPULATION
The sample will consist of children with disruptive behavior problems who have been referred to one of the five participating Dutch mental healthcare centers. To enhance the generalizability of the results, we aim to include a diverse sample of the Dutch population of children with disruptive behaviors, thus, from a broad age range (2-12 years), of both sexes, and all cultural and socioeconomic backgrounds.
Based on (1) our prior study where we found medium short term effects on momentary assessed (i.e., daily) ratings of disruptive behavior compared to waitlist (range of Cohen's d .44 to .63, Hornstra et al., 2021); (2) studies showing medium intervention effects on disruptive behavior using parent-report rating scales (e.g., ECBI-I; see Appendix 5); and (3) the expectation that the care as usual will have small effects on disruptive behaviors, we estimate the effect of our brief parent training program as compared to CAU to be at least small (d = 0.25).
A power analysis has been performed using G*Power software (Faul et al., 2007). Based on an effect size of d = 0.25, two groups and three repeated measures (T0, T1, T2 for short term effectivity, with r = .60 between-measurement relation, a power of .80 and alpha = 0.25 (because we have two primary outcomes, alpha was set at .025), we need 50 participants per group, resulting in a total of 100 participants. Given that our data is clustered, we multiplied our total sample with 110%, resulting in a total number of 110 participants. This is in line with the number of participants in similar studies comparing behavioral treatments to treatment as usual (e.g., Van den Hoofdakker, 2007).
- 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 care as usual after the parent training program. 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 disruptive behaviors (e.g., hyperactivity, impulsivity, symptoms of oppositional defiant and conduct disorder) 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 disruptive behaviors 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.
- METHODS
Demographic information about participants will be collected with a self-composed questionnaire, which measures age, gender, ethnicity, educational background, household composition, previous pharmacological and non-pharmacological treatments, medical conditions and clinical classifications) .
PRIMARY AND SECONDARY STUDY PARAMETERS
The primary outcomes of the study will be (a) the severity of four individual target disruptive behaviors that parents want to address in the training and (b) parent-reported disruptive behaviors on the Intensity scale of the Eyberg Child Behavior Inventory (ECBI-I). The secondary outcomes of the study will be 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 values. The investigators will furthermore explore parents' and therapists' evaluations of the brief parent training program. All outcomes are described in more detail below.
MODERATORS
The moderators of the study will be parental attachment as measured with the 12-item version of the Revised Experiences in Close Relationship (ECR-R) questionnaire (Wei et al., 2007), parental psychopathology as measured with the 25 items of the Strengths and Difficulties questionnaire (SDQ) for parents (https://www.sdqinfo.org/Adult/), parental reward responsivity as measured with the 8-item Reward Responsiveness (RR) questionnaire (Van den Berg et al., 2010), and parent-reported child reward responsivity and punishment sensitivity as measured with 22 items of the Sensitivity to Punishment and Sensitivity to Reward Questionnaire for Children (SPSRQ-C) (Luman et al., 2012).
STUDY PROCEDURES
Parents of children with disruptive behavior problems who have been referred to one of the five participating Dutch mental healthcare centers (Accare, Levvel, Dokter Bosman, UvA minds, and Praktijk Kuin) will be recruited by clinicians within these centers. After the diagnostic assessment of their child and before any treatment has started, the clinicians involved in the diagnostic phase will inform parents about the study and hand out the information letter. Parents who are interested can give their contact information to the clinicians. The researchers will use this contact information to further inform parents about the research through telephone calls. If parents want to participate, the researchers will ask them to provide informed consent. Both legal caretakers (if present) of the child are asked to provide consent. Parents will have at least 14 days to decide upon participation and ask the researchers any questions. If needed, parents can ask for more time to decide upon participation.
To measure the primary and secondary outcomes and candidate moderators of treatment response, parents in both treatment arms will be asked to make audiotapes of their mealtime routines, fill out questionnaires, and answer short daily phone calls (five days in a row) on four measurement occasions.
For parents in the intervention condition, these measurements will occur be before the brief training (T0), one week after the brief training (T1), six months after T1 (T2), and twelve months after T1 (T3). For parents in the control condition, similar measurement time points will be used as for parents in the intervention condition: at baseline, before any intervention (T0), eight weeks after T0 (T1), six months after T1 (T2), and twelve months after T1 (T3 ). The questionnaires will together take 30 to 45 minutes per measurement occasion and making the audiotapes and the phone calls will take two to three minutes each per measurement occasion. Furthermore, parents in the intervention condition will fill out the ECBI-I questionnaire during and two weeks after each booster session, which will take a couple of minutes. The parent advisory board considers this time investment to be acceptable.
Subjects can leave the study at any time for any reason if they wish to do so without any consequences.
- STATISTICAL ANALYSIS
PRIMARY AND SECONDARY STUDY PARAMETERS
Data will be analyzed on an intention-to-treat basis. Differences between the arms in demographic variables will be analyzed with ANOVA's (continuous variables) and chi-squared tests (categorical variables). To examine the effects of the intervention on the primary outcomes we will conduct multilevel analyses (mixed modeling). Mixed model analysis takes missing data into account (Twisk et al., 2013). Four hierarchical levels will be distinguished: outcomes (level 1), nested within children (level 2), nested within therapists (level 3), nested within sites (level 4).
To assess cost-effectiveness of the intervention compared to CAU we will calculate the Incremental Cost effectiveness Ratio (ICER) from a societal perspective. We will perform both a cost utility analysis (based on quality-adjusted life years, calculation based on the EQ-5D; QALYs) and a cost-effectiveness analysis (based on ECBI scores). An ICER is calculated by dividing the difference in total cost, by the difference in total effect (either utility or point on the ECBI). We will compare this ICER based on relevant willingness to pay thresholds. Bootstrapping will be used to calculate the reliability of our estimate.
For these analyses, health care costs (including cost for mental health care) will be constructed by multiplying consumption by the reference prices provided in the Cost Manual of the Dutch National Health Care Institute. Costs of medication by using prices provided by the Dutch National Health Care Institute (medicijnkosten.nl). Costs in other sectors will be calculated using reference prices provided in the Manual Intersectoral Costs and Benefits (Drost et al., 2014). These costs will be extrapolated to the previous 12 months.
To examine the effects of the intervention on the secondary outcomes we will also conduct multilevel analyses (mixed modeling) with four hierarchical levels: outcomes (level 1), nested within children (level 2), nested within therapists (level 3), nested within sites (level 4).
MODERATORS
To examine whether the candidate moderating variables influence the effect of the treatment, these variables will be added as interaction effects to the multilevel analysis.
- ETHICAL CONSIDERATIONS
The children with disruptive behaviors (i.e., minors) will not be directly involved in the study. Specifically, they will not be present during the brief parent training sessions and all measures will be parental measures. Furthermore, diverse populations and participants will not be denied treatment.
Parents in the parent training condition will receive a brief parent training program that uses the behavioral techniques that were identified as effective for disruptive behaviors (e.g., hyperactivity, impulsivity, symptoms of oppositional defiant and conduct disorder) in our recent microtrial (Hornstra et al., 2021) and the broader literature. The risk of any physical or mental harm of the study is very low and not to be expected higher than what may be expected in daily life of the parents and their children. We will exclusively use conventional methods and interventions and the study is embedded in mental healthcare settings. The children of participating parents have been referred for disruptive behavior and parents who visit the participating clinical institutions seek treatment for these problems. Adverse effects of the parent training will be monitored (Allan & Chacko, 2018; Linden, 2013) and can be evaluated with the therapist in subsequent sessions to see if and how problems can be resolved as part of the training or in additional booster sessions. After the parent training, parents wishing to receive additional guidance can request extra booster sessions and/or care as usual, depending on their needs. Tailoring the care that will be provided to parents' needs will minimize the chance of any physical or mental harm.
To debrief participants, after the study is finished parents who wish to learn about the results of the study can request this information from the researchers. We will inform parents about the possibility to ask for this information in the information letter.
- ADMINISTRATIVE ASPECTS, MONITORING AND PUBLICATION
HANDLING AND STORAGE OF DATA AND DOCUMENTS
Digital data, both raw and processed/analyzed data will be stored at a study specific highly secured folder within the Accare network. This study specific folder can only be accessed by authorized personnel, who are involved in this study.
All questionnaire data and processed audio files will be stored in one, pseudonymized file, that is accompanied by a 'readme' text file that contains a code book explaining the meaning of all variables. The file contains separate pages ("tabs") for all different questionnaires at all different timepoints. A separate logbook-file will be created documenting all decisions that will be made during the process from raw to published data. Old versions of all these documents will be stored, document names will contain their date to ensure version control.
Non-digital data (e.g. paper questionnaires) will be stored in a locked archive at Accare.
Management of the data and access permissions are with the principal investigator of the research project.
Access permissions are controlled by the research project's principal investigator. Raw data containing identifiable information such as the separate log containing patient identification number and study code will be kept strictly separate from the processed data and can only be accessed by the supervisors, research assistant and PhD student. The processed, pseudonymized data will be available for fellow researchers and made available (restricted access) for re-use. Requests for re-use of data will be evaluated by the steering committee who will check whether the research question falls within the scope of the informed consent .
After the research project has been completed (i.e., data collection, data analysis and publishing of research articles completed) all the digital data will be transferred to a study specific folder for long-term storage. The folder can only be accessed by the Principal Investigator and by authorized personnel after approval of the Principal Investigator. This data storage environment allows for careful access management and is only accessible with username and password. Data storage is backed-up automatically daily.
All the research data will be stored for 15 years after the data collection has been completed (i.e. last research assessment for the last patient has been performed). Raw audio-files, that may contain personal information, will be stored for 15 years in an encrypted folder.
MONITORING AND QUALITY ASSURANCE
Intervention integrity will be assessed using procedures of Abikoff (Abikoff et al., 2013; Abikoff et al., 2014). This implies that all intervention sessions (including the booster sessions) will be audiotaped. For every therapist delivering the training, the first session will be checked and therapists will receive feedback on intervention integrity and fidelity by cognitive behavior therapists with extensive experience in behavioral parent training programs. Further, audiotapes of 20% randomly selected sessions will be scored on intervention integrity and fidelity during the study by independent evaluators. After each session, the therapists/clinicians have to complete a fidelity checklist in which they will be asked which topics were covered. During the entire study, therapists and researchers will have monthly meetings to monitor intervention integrity of the sessions.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Brief behavioral parent training with optional booster sessions A brief, individualized, three-session parent training that exists of two (bi)weekly individually tailored training sessions of two hours and a third session of one hour in which the training will be evaluated, and maintenance training will be provided. After that, parents wishing to receive additional support can receive single booster sessions maximum once every four weeks and/or receive care as usual. |
Behavioral: Brief behavioral parent training with optional booster sessions
A brief and individually-tailored behavioral parent training program that combines stimulus control and contingency management techniques to treat children's disruptive behaviors in three (bi)weekly sessions and optional booster sessions.
Other Names:
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| Active Comparator: Care as usual (CAU) The care that is usually provided by the clinical institutions to treat children's disruptive behaviors. There will be no restrictions regarding type or duration of CAU (only the brief parent training will not be allowed) which may for example include psychoeducation, (long) parent training, child treatment (e.g., pharmacotherapy, cognitive behavioral therapy) or family therapy. |
Behavioral: Care as usual
The care that is usually provided by the clinical institutions to treat children's disruptive behaviors. There will be no restrictions regarding type or duration of CAU (only the brief parent training will not be allowed) which may for example include psychoeducation, (long) parent training, child treatment (e.g., pharmacotherapy, cognitive behavioral therapy) or family therapy.
Other Names:
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Outcome Measures
Primary Outcome Measures
- Change in individually determined daily ratings of disruptive behaviors [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)]
The first primary outcome measure will be change in parents' daily ratings of four selected target behaviors. Target behaviors will be selected from an adapted version of the List of Target Behaviors. On a list of 31 problem behaviors parents indicate whether these behaviors occur daily (yes/no). For the items scored as yes parents rate the severity of the behaviors on a 5-point Likert scale ranging from 1 (not severe) to 5 (extremely severe). Parents will choose four target behaviors from this list that they prefer to work on in the training. They will also be asked in which situations these behaviors occur. For each measurement occasion, during at least four consecutive schooldays, we will make daily phone calls with parents to evaluate whether the four selected target behaviors occurred in the past 24 hours in the selected situation (yes/no). Items scored as Yes will be rated on a 5-point Likert scale ranging from 1 (not severe) to 5 (extremely severe).
- Change in parent-reported disruptive behaviors [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.]
The second primary outcome measure will be change in parent-reported disruptive behaviors. Children's disruptive behaviors will be assessed by the Dutch version of the Intensity scale of the Eyberg Child Behavior Inventory (ECBI-I). The ECBI-I is a 36-item questionnaire for parents of children aged 2 to 16, consisting of two scales. The Intensity scale measures the frequency of specific problem behavior on a 7-point Likert scale from 1 (never) to 7 (always). On the Problem scale, parents report whether the specific behavior-item is problematic for parents or not on a dichotomous scale (0=no; 1=yes).
Secondary Outcome Measures
- Change in child well-being [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 child well-being will be assessed with the Health-Related Quality of Life Questionnaire (KINDL-R). Parents will rate their children's quality of life on 20 items regarding emotional well-being, self-esteem, family functioning, social contacts, and school. Parents have to rate the items on a Likert scale ranging from never (1) to all the time (5).
- Change in parenting behaviors [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 will be assessed with the Alabama Parenting Questionnaire (APQ). The APQ is a 42-item parent-report measure assessing five categories of parenting practices (Involvement, Positive Parenting, Poor Monitoring/Supervision, Inconsistent Discipline, and Corporal Punishment). Parents will rate on a 5-point scale ranging from 1 (never) to 5 (always), with higher scores representing higher levels of the particular parenting category.
- Change in parent and child behaviors (audiotapes - masked measure) [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 parent and child behaviors will also be assessed with a masked measure, based on the method that was used by Herbert et al. (2013). Parents will be asked to audio record their mealtime routines (also according to out parent advisory board, audio records are preferred over video records given that they are perceived as less invasive and interfering). Mealtimes are notoriously busy times in family lives and are thus excellently suited as an ecologically valid measure. Using this recording the following behaviors will be scored using a global coding system: parental behavior (both positive and negative parenting), child misbehavior/negative behavior, and emotional talk. All tapes will be scored by an assessor masked to treatment allocation. A subsample of tapes will be double coded to calculate interrater reliability.
- Change in parenting stress [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 stress will be assessed with the Parental Stress Scale (PSS). The PSS is an 18-item parent report scale that measures positive (e.g., emotional benefits) and negative (e.g., restrictions) aspects of parenting. Parents have to agree or disagree with statements concerning parenting (e.g., "Caring for my child(ren) sometimes takes more time and energy than I have to give.") on a 5-point scale ranging from 1 (strongly disagree) to 5 (strongly agree).
- Change in parenting self-efficacy [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 will be measured with the Efficacy subscale of the Parenting Sense of Competence Scale (PSOC). On the eight items of this subscale, parents have to rate their capability level and problem-solving ability regarding their parental role on a 6-point scale, ranging from strongly disagree (1) to strongly agree (6).
- Change in quality of the parent-child relation [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 will be measured with the parent version of the Ouder-Kind Interactie Vragenlijst-Revised (OKIV-R), which is the Dutch version of the Parent-Child Interaction Questionnaire-Revised (PACHIQ-R). On 21 items, parents have to rate their relationship with their child on a 5-point scale, ranging from strongly disagree (1) to strongly agree (5). The OKIV-R measures the parent-child relationship on two subscales: Acceptance and Conflict resolution, and as a total score.
- Evaluations of the program by parents - Questionnaire [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.]
To measure parents' satisfaction and opinion about the brief parent training, parents will be asked to fill in a self-developed satisfaction questionnaire, which is based on questions of the Parent Satisfaction Questionnaire, the Therapy Attitude Inventory, and the questionnaire that was used in Breider et al. (2019). Parents have to answer 13 questions about their satisfaction with the brief parent training on T1 and 3 questions about their satisfaction with the booster sessions (if used) on T3 on a 5-point scale ranging from 1 (strongly disagree) to 5 (strongly agree) and give the brief parent training a grade between 1 (bad) and 10 (good).
- Evaluations of the program by parents - Focus Groups [After the inclusion of participants in the trial is finished, which is anticipated to be in January 2025.]
To measure parents' satisfaction and opinion about the brief parent training, focus groups will be organized with a number of participating parents. In these groups the new program will be qualitatively evaluated and important information about feasibility and barriers and facilitators for the implementation of the training in clinical settings will be gathered.
- Evaluations of the program by therapists - Questionnaire [After the inclusion of participants in the trial is finished, which is anticipated to be in January 2025.]
To measure therapists' satisfaction and opinion about the brief parent training, therapists will be asked to fill in a self-developed satisfaction questionnaire, which is based on questions of the Parent Satisfaction Questionnaire, the Therapy Attitude Inventory, and the questionnaire that was used in Breider et al. (2019). Therapists have to answer approximately 15 questions on a 5-point scale ranging from 1 (strongly disagree) to 5 (strongly agree) and give the brief parent training a grade between 1 (bad) and 10 (good).
- Evaluations of the program by therapists - Focus Groups [After the inclusion of participants in the trial is finished, which is anticipated to be in January 2025.]
To measure therapists' satisfaction and opinion about the brief parent training, focus groups will be organized with a number of therapists, in which important barriers and facilitators for implementation of the program will be identified.
- Change in consumption of health care [Before the brief training/before any intervention (T0) and twelve months after T1 (T3).]
Change in consumption of mental health care within the organization where the child is treated will be measured by drawing up an inventory (based on patient records) of the use of the booster sessions and CAU. Consumption of other health care will be assessed with a questionnaire on intensive youth care ('Vragenlijst Intensieve Jeugdzorg'). Parents will complete this modular questionnaire about the use and intensity of health care of both child and parent in the past three months. Also, losses in productivity of the parent will be assessed by this instrument.
- Change in costs of health care [Before the brief training/before any intervention (T0) and twelve months after T1 (T3).]
Change in health care costs (including cost for mental health care) will be constructed by multiplying consumption by the reference prices provided in the Cost Manual of the Dutch National Health Care Institute. Costs of medication by using prices provided by the Dutch National Health Care Institute (medicijnkosten.nl). Costs in other sectors will be calculated using reference prices provided in the Manual Intersectoral Costs and Benefits. These costs will be extrapolated to the previous 12 months.
- Change in utilities [Before the brief training/before any intervention (T0) and twelve months after T1 (T3).]
Change in utilities will be calculated based on the EuroQol-5D-5L (EQ-5D) questionnaire, which parents will be asked to fill out. The EuroQol-5D-5L measures five items (mobility, self-care, daily activities, pain, and anxiety/depression) on a 5-level categorical scale.
Eligibility Criteria
Criteria
Inclusion Criteria:
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The child is aged between 2 and 12 years;
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Parents have to identify at least four disruptive behaviors of the child at home that they want to target in the training (using a list of 25 target disruptive behaviors (Van den Hoofdakker 2007; Hornstra et al., 2021). The items are based on child behaviors that are commonly targeted in parent training in clinical practice, confirming ecological validity.
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Parents have to rate their child > 130 (sumscore) on the Intensity scale of the Eyberg Child Behavior Inventory (ECBI-I), which contains 36 items on which parents rate the intensity of their child's disruptive behaviors from 1 (never) to 7 (always).
Exclusion Criteria:
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Psychotropic medication use of the child (currently or in the month before the training);
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The child has received a clinical diagnosis of autism spectrum disorder;
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The child has a known IQ-score < 70. When no IQ-score is available, the child can be included in the study and the IQ-score does not have to be measured;
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Parents received parent training aimed at remediating disruptive behaviors of the concerned child in the year before the study;
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Not a suitable period for the parents and/or the child to participate in the study (e.g., moving, divorce);
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The child is not living in the same household during at least four weekdays, to ensure that our primary measure will be reported by the same informant(s).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Accare | Groningen | Netherlands | 9723 HE |
Sponsors and Collaborators
- Accare
Investigators
- Principal Investigator: Barbara J. Van den Hoofdakker, Prof. dr., Accare Child Study Center; University Medical Center Groningen; University of Groningen
- Principal Investigator: Saskia Van der Oord, Prof. dr., KU Leuven
Study Documents (Full-Text)
None provided.More Information
Publications
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- Abikoff HB, Thompson M, Laver-Bradbury C, Long N, Forehand RL, Miller Brotman L, Klein RG, Reiss P, Huo L, Sonuga-Barke E. Parent training for preschool ADHD: a randomized controlled trial of specialized and generic programs. J Child Psychol Psychiatry. 2015 Jun;56(6):618-31. doi: 10.1111/jcpp.12346. Epub 2014 Oct 16.
- Allan, C., & Chacko, A. (2018). Adverse events in behavioral parent training for children with ADHD: An under-appreciated phenomenon. The ADHD Report, 26(1), 4-9. https://doi.org/10.1521/adhd.2018.26.1.4
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- Bearss K, Johnson C, Handen B, Smith T, Scahill L. A pilot study of parent training in young children with autism spectrum disorders and disruptive behavior. J Autism Dev Disord. 2013 Apr;43(4):829-40. doi: 10.1007/s10803-012-1624-7.
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- Breider S, de Bildt A, Nauta MH, Hoekstra PJ, van den Hoofdakker BJ. Self-directed or therapist-led parent training for children with attention deficit hyperactivity disorder? A randomized controlled non-inferiority pilot trial. Internet Interv. 2019 Aug 8;18:100262. doi: 10.1016/j.invent.2019.100262. eCollection 2019 Dec.
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- Dekkers TJ, Hornstra R, van der Oord S, Luman M, Hoekstra PJ, Groenman AP, van den Hoofdakker BJ. Meta-analysis: Which Components of Parent Training Work for Children With Attention-Deficit/Hyperactivity Disorder? J Am Acad Child Adolesc Psychiatry. 2022 Apr;61(4):478-494. doi: 10.1016/j.jaac.2021.06.015. Epub 2021 Jul 2.
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- Hornstra R, van der Oord S, Staff AI, Hoekstra PJ, Oosterlaan J, van der Veen-Mulders L, Luman M, van den Hoofdakker BJ. Which Techniques Work in Behavioral Parent Training for Children with ADHD? A Randomized Controlled Microtrial. J Clin Child Adolesc Psychol. 2021 Nov-Dec;50(6):888-903. doi: 10.1080/15374416.2021.1955368. Epub 2021 Aug 23.
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- METc 2022/221
- file number 60-63600-98-1