Psychosocial ADHD Interventions - Brief Parent Training — PAINT  

ADHD Clinical Trial

Official title: A Non-randomized Pilot Study on Brief Behavioral Parent Training for Behavioral Problems of Children With ADHD Symptoms.

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• ADHD
• ADHD - Combined Type
• ADHD Predominantly Inattentive Type
• Attention Deficit Disorder with Hyperactivity
• Behavior Problem
• Behavioral Problem
• Behavioral Symptoms
• Child Behavior Problem
• Disruptive Behavior
• Problem Behavior

• NCT number: NCT05452954
• Study type: Interventional
• Source: Accare
• Status: Completed
• Phase: N/A
• Start date: March 16, 2021
• Completion date: April 6, 2023