Clinical trial NCT05452954: Psychosocial ADHD Interventions - Brief Parent Training
Official title: A Non-randomized Pilot Study on Brief Behavioral Parent Training for Behavioral Problems of Children With ADHD Symptoms.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: 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
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
Lead sponsor: Accare
Sponsor class: OTHER
First posted: 2022-07-12
Enrollment: 28
Sex: ALL
Minimum age (years): 4
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: open label
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* A) The child is diagnosed with ADHD according to DSM-5 as measured by the Parent Interview for Child Symptoms \[PICS\] and the Teacher Telephone Interview \[TTI\] or; B) The child has at least four impairing symptoms of ADHD (at least four symptoms of ADHD as measured by the Parent Interview for Child Symptoms \[PICS\] and at least two symptoms measured by the Teacher Telephone Interview \[TTI\]; and significant impairment rated \>3 on the Impairment Rating Scale \[IRS\]).
* The child is between four up to and including eleven years old and is attending a Dutch primary school.
* The child has an IQ higher than 70. If an IQ-score is not available, this will be estimated with two subtests of the Wechsler Intelligence Scale for Children-V (Dutch edition; WISC-V-NL) or the Wechsler Preschool and Primary Scale of Intelligence-III (Dutch edition; WPSSI-III-NL).
* Parents/caregivers have given their informed consent for participation.

Exclusion Criteria:

* Parents received behavioral parent training (individual or group) aimed at ADHD or behavioral problems of the child in the past year.
* The child is currently taking psychotropic medication or has taken psychotropic medication in the past month.
* The child has a DSM-5 or a DSM-IV-TR based diagnosis of an Autism Spectrum Disorder.
* There are problems with the child and/or the family that require immediate intensive intervention (e.g., crisis in the family).
* The child does not live in one household during weekdays.

Primary outcomes:
measure: Change in daily ratings of target behaviors by ecological momentary assessment
timeFrame: T0 (baseline) 1 week before intervention; T1 (post-training 1) 1 week after intervention session 2; T2 (post-training 2) 3 weeks after intervention session 2; T3 (follow-up) 3 weeks after intervention booster session.
Secondary outcomes:
measure: Change in inattentive, hyperactive and impulsive behaviors of the child.
timeFrame: T0 (baseline) 1 week before intervention; T2 (post-training) 3 weeks after intervention session 2; T3 (follow-up) 3 weeks after intervention booster session
measure: Change in children's symptoms of oppositional defiant disorder
timeFrame: T0 (baseline) 1 week before intervention; T2 (post-training) 3 weeks after intervention session 2; T3 (follow-up) 3 weeks after intervention booster session
measure: Change in disruptive problem behaviors of the child
timeFrame: T0 (baseline) 1 week before intervention; T2 (post-training) 3 weeks after intervention session 2; T3 (follow-up) 3 weeks after intervention booster session
measure: Change in impairment of the child
timeFrame: T0 (baseline) 1 week before intervention; T2 (post-training) 3 weeks after intervention session 2; T3 (follow-up) 3 weeks after intervention booster session
measure: Change in parenting sense of competence
timeFrame: T0 (baseline) 1 week before intervention; T2 (post-training) 3 weeks after intervention session 2; T3 (follow-up) 3 weeks after intervention booster session
Other outcomes:
measure: Parent satisfaction
timeFrame: T3 (follow-up) 3 weeks after intervention booster session
measure: Parent-rated acceptability of outcome measures
timeFrame: T3 (follow-up) 3 weeks after intervention booster session
measure: Therapist satisfaction
timeFrame: Through study completion, an average of 1,5 year.
measure: Treatment fidelity
timeFrame: Through study completion, an average of 1,5 year.
measure: Retention rate
timeFrame: Through study completion, an average of 1,5 year.
measure: Response and completion rate
timeFrame: Through study completion, an average of 1,5 year.
Locations:
city: Groningen
country: Netherlands
facility: Accare
Study officials:
affiliation: Accare
name: B. J. Van den Hoofdakker, Prof. dr.
role: PRINCIPAL_INVESTIGATOR
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