Psychosocial ADHD Interventions - Brief Parent Training
Condition: ADHD; ADHD - Combined Type; ADHD Predominantly Inattentive Type; ADHD, Predominantly Hyperactive-Impulsive Type; Behavior Problem; Behavioral Problem; Problem Behavior; Behavioral Symptoms; Child Behavior Problem; Disruptive Behavior
MeSH terms: Attention Deficit Disorder with Hyperactivity; Problem Behavior; Behavioral Symptoms
Study type: Interventional

Summary: 
      This pilot study investigates a new, easily applicable, individually tailored first-line
      behavioral training for parents of children (4-12 years) with (symptoms of) ADHD, that will
      be provided in an early stage, before other treatments have been applied. In this pilot study
      the feasibility of the newly developed intervention will be evaluated by exploring program
      acceptability, including client satisfaction, recruitment, retention, treatment fidelity and
      therapist satisfaction. Also acceptability of potential outcome measures will be explored,
      including preliminary tests of efficacy.
    

Detailed description: 
      The study will be a non-randomized pilot study. The newly developed brief behavioral parent
      training has not been studied yet. Therefore, the current project aims at evaluating its
      feasibility. Furthermore, this project aims to explore whether parents' and their children's
      functioning improves from pre to post intervention. This will be assessed by investigating
      changes over time in the treatment group, and, if possible, by comparing these with changes
      in a control group that was included in a previous microtrial with an almost identical design
      and intervention.

      OBJECTIVES

      The primary objective of this study is evaluating the feasibility of the newly developed
      behavioral parent training This will be done by exploring its acceptability, including client
      satisfaction, recruitment, retention, treatment fidelity and therapist satisfaction.
      Furthermore, the acceptability of both primary and secondary outcome measures will be
      evaluated on a number of variables, such as frequency and duration of the assessment
      according to participants and response and completion rates. Preliminary tests of efficacy
      will be conducted by investigating changes over time in the treatment group, and, if
      possible, comparing all outcome measures with control data from a previous study that has an
      almost identical design.

      METHODS

      Design

      Baseline measurement (all outcome measures) will be done one week before session 1 (T0). The
      primary outcome will be assessed one and three weeks after session 2 (T1 and T2). At T2, all
      other outcome measures will be assessed as well. Follow-up measurement (all outcome measures)
      will be done three weeks after the booster session (T3). Sessions and measurements are
      planned the same way as could be done in a future RCT.

      Participants

      Participants are parents of children between four up to and including eleven years old with
      behavioral problems and diagnosed with ADHD or at least four symptoms of ADHD according to
      DSM-5.

      Treatment

      The intervention consists of three sessions; two two-hours training sessions and a one-hour
      booster session. Treatment will take place in an outpatient child and adolescent mental
      health setting. Therapists will be well-trained in behavioral techniques and experienced in
      behavioral parent training for children with behavioral problems.

      Outcome variables

      To assess feasibility, the following outcome measures are investigated:

        -  Parent satisfaction (25 items)

        -  Parent-rated acceptability of primary and secondary outcome measures (7 descriptive
           items)

        -  Therapist satisfaction (short self-developed evaluation questionnaire)

        -  Treatment fidelity (audio records of sessions; percentage addressed session items)

        -  Recruitment (average number of included patients each month, number of patients meeting
           the inclusion criteria but not willing to participate)

        -  Retention rate (percentage study drop-out and percentage treatment drop-out)

        -  Response and completion rates on outcome measures (percentage of parents that responded
           at all timepoints, percentage of completed measures at all time-points)

      For a preliminary test of efficacy, primary outcomes are daily ratings of four individually
      selected target behaviors. Secondary outcomes are:

        -  Inattentive, hyperactive and impulsive behaviors of the child (SWAN)

        -  Children's symptoms of oppositional defiant disorder (DBDRS)

        -  Disruptive problem behaviors of the child (ECBI)

        -  Impairment of the child (IRS)

        -  Parenting sense of competence (PSOC) See 'Outcomes Measures' for more details on all
           measures.

      Statistics

      For a preliminary test of efficacy, two research questions are formulated. The primary
      research question concerns the change from pre to post intervention within the treatment
      group. To analyze whether participants improve on daily ratings of problem behavior (primary
      outcome measure), a weekly mean-level will be derived on the basis of the daily ratings of
      the selected target behaviors in specific situations over five schooldays.

      The secondary research question for preliminary efficacy concerns the comparison of the
      treatment group with historic controls. The change on primary and secondary outcome measures
      in the intervention group will be compared to the change in the historic control group.

      Both research questions will be answered by a multilevel analysis (mixed modeling), which
      takes missing data into account. Three hierarchical levels will be distinguished: outcomes
      (level 1) nested within subjects (level 2), nested in therapists (level 3). A random
      intercept at therapist level will be included only if the Likelihood Ratio Test shows a
      significant improvement of the model fit. Condition (parent training vs control) will be
      inserted as between subjects factor and time (T1, T2, T3) as within subjects variable. To
      control for baseline differences, T0 scores will be inserted as fixed factor. As an historic
      control group will be used, also age, sex, ADHD symptoms (as measured by the SWAN) and ODD
      symptoms (as measured by the DBDRS) at T0 will be included, but only when groups differ on
      these variables at T0.

      Data will be analyzed on an intention to treat basis. In all statistical analyses an alpha of
      0.05 will be used.

      Power analysis

      A power analysis was executed for the primary pre-post within group analysis. Taking into
      account the lowest within condition effect size found in a previous study on brief behavioral
      parent training (d=.57), an effect size of f=.285 (f=d/2) is assumed for this power analysis.
      Given alpha=.05 and power 1-β=.80, a total number of 28 study participants will be required.
    

Intervention name(s): Brief behavioral parent training
Intervention type(s): Behavioral
Intervention description(s): In the newly developed intervention, both stimulus control and contingency management techniques will be offered in a brief behavioral parent training consisting of two intervention sessions and one booster session.
Other intervention name(s): paint-p; Psychosocial ADHD Interventions - Parent-training
Intervention model: Single Group Assignment
Intervention model description: open label
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: behavioral parent training; brief behavioral parent training; first-line behavioral parent training; psychosocial ADHD intervention; parent training; first-line treatment ADHD; children 4-11 years