Clinical trial NCT06040996: Evaluation of Improving Parenting Skills Adult ADHD (IPSA): A New Parent Training Program for Parents With ADHD
Official title: A Randomized Controlled Trial of Improving Parenting Skills Adult ADHD (IPSA): A New Parent Training Program for Parents Who Themselves Have ADHD
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Parenting
Adult ADHD
Parent-Child Relations
Child Behavior Problem
Keywords: Parenting
Parent training
Parental ADHD
Parenting skills
Parental Self-Efficacy
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Region Stockholm
First posted: 2023-09-18
Enrollment: 109
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: IPSA (Improving Parenting Skills adult ADHD) is a new parent training (PT) program developed and adapted for parents who themselves have Attention-Deficit/Hyperactivity Disorder (ADHD).

This study evaluates the efficacy of the IPSA program, that is, whether participation in IPSA is associated with desired treatment outcomes (e.g., improved parental self-efficacy). In addition, it examines the program's feasibility (e.g., what parents think about the program, the extent to which parents complete the program, and program safety).

The study is a so called randomized controlled trial (RCT), where participants are randomly assigned to one of two groups: Treatment (IPSA) or Control (continued routine services; offered IPSA approximately six months later).

Participants are adults with ADHD (any form) that have at least one child in the ages between 3 and 11 years. Data are primarily collected using questionnaires, completed by parents before and after IPSA, as well as in connection with an IPSA booster session (follow-up).

Detailed description: DESIGN: An RCT with parallel groups, where eligible individuals are block randomized on each clinical site to one of two groups (ratio 1:1): Treatment (IPSA directly) or Control (continued routine services; offered IPSA approximately six months later). Each block includes 18 participants. Randomization is done using a digital randomization tool. Allocation (treatment or control) is masked to participants and study staff administering the screening/inclusion/assessment procedures until after the baseline assessment (including pre-intervention questionnaires) has been completed.

SETTING: The study is carried out by the Center of Neurodevelopmental Disorders at Karolinska Institutet (KIND), Karolinska Institutet, Sweden, in collaboration with an ADHD Center run by the publicly-funded Habilitation \& Health, Stockholm Health Care Services, Region Stockholm, Sweden. Originally, the plan was to gradually involve external clinical sites (e.g., regular outpatient psychiatric clinics) in the data collection. However, this plan was first postponed and later cancelled due to the Covid-19 pandemic.

ETHICS: The study has been approved by the Regional Ethics Committee of Stockholm, Sweden (dnr. 2017/2435-31/5, 2019-06362, and 2023-03871-02).

PARTICIPANTS: Parents (≥ 18 years of age) with a formal ADHD diagnosis (any form) having at least one child aged 3 to 11 years, recruited via the project web site as well as among families enrolled at the involved clinical site.

SAMPLE SIZE: Power calculations (with 1 - β = .80, α = .05, medium to large effect sizes) has resulted in an estimated sample size of n ≥ 100.

RESEARCH QUESTIONS: The research questions are primarily concerned with the efficacy of IPSA, secondarily with the feasibility of the program. In addition, the investigators will explore the potentially moderating or mediating effects of baseline variables and levels of active participation on efficacy outcomes.

EFFICACY: The effect of IPSA is examined using self- and parental report scales administered before (pre; T1) and immediately after (post; T2) IPSA, as well as approximately 1.5-3 months after program completion, in connection with an IPSA booster session (follow-up; T3). Specifically, the investigators examine whether participation in IPSA is associated with positive treatment outcomes with respect to the study's primary outcome (parental self-efficacy) and secondary outcomes (parental stress, levels of household disorganization or frequency and perception of disruptive behavior problems in the participant's target child). In addition, parents' time management and organizational skills are followed from pre to post IPSA.

FEASIBILITY: The feasibility of IPSA is evaluated based attendance records and parental reports. The investigators assess whether IPSA is an acceptable intervention (i.e., treatment satisfaction, treatment credibility), examine levels of active participation (i.e., program completion rates, levels of homework completion, use of introduced parenting skills, and management of a targeted parent-child interaction situation), and monitor potential harms (including parental reports of general perceived stress, symptoms of anxiety/depression and adverse events).

TREATMENT INTEGRITY: Intervention sessions are recorded (audio only). Treatment integrity (assessed in terms of facilitator adherence/fidelity) is examined in 20% of group sessions (randomly selected), using checklists covering program elements and content.

Eligibility criteria: Inclusion Criteria: Adults (≥ 18 years) with a formal ADHD diagnosis (any form), having:

* at least one child in the ages between 3 and 11 years
* sufficient knowledge of Swedish to participate actively in the intervention without an interpreter
* possibility to participate in the intervention during the intended period (regardless of allocation)

Exclusion Criteria:

* other neurodevelopmental disabilities, that is autism or intellectual disability
* ongoing serious psychiatric condition (e.g., major depression, suicidality, psychosis, substance use disorder) for which treatment needs to be prioritized
* ongoing family crisis or equivalent that needs to be prioritized with other types of interventions

Primary outcomes:
measure: Parental Self-Efficacy
timeFrame: Administered at baseline (pre IPSA; T1) and immediately after the intervention (post IPSA; T2), as well as at follow-up (up to three months after program completion; T3).
Secondary outcomes:
measure: Parental Stress
timeFrame: Administered at baseline (pre IPSA; T1) and immediately after the intervention (post IPSA; T2), as well as at follow-up (up to three months after program completion; T3).
measure: Household Disorganization/Home Chaos
timeFrame: Administered at baseline (pre IPSA; T1) and immediately after the intervention (post IPSA; T2), as well as at follow-up (up to three months after program completion; T3).
measure: Child behavior problems
timeFrame: Administered at baseline (pre IPSA; T1) and immediately after the intervention (post IPSA; T2), as well as at follow-up (up to three months after program completion; T3).
Other outcomes:
measure: Time management and organizational skills
timeFrame: Administered at baseline (pre IPSA; T1) and immediately after the intervention (post IPSA; T2).
measure: Feasibility (acceptability): Program acceptability
timeFrame: Immediately after program completion (up to six months after baseline).
measure: Feasibility (acceptability): Session acceptability
timeFrame: At the end of each IPSA session, up to the booster session (up to three months after program completion).
measure: Feasibility (acceptability): Intervention Credibility
timeFrame: Up to six weeks after baseline.
measure: Feasibility (active participation): Program completion
timeFrame: Attendance is registered for every IPSA session, up to the booster session (up to three months after program completion).
measure: Feasibility (active participation): Homework completion
timeFrame: At the beginning of IPSA sessions 6 through 14 (up to six months after baseline).
measure: Feasibility (active participation): Use of introduced parenting skills
timeFrame: At baseline (pre IPSA; T1) and immediately after the intervention (post IPSA; T2), as well as at follow-up (up to three months after program completion; T3).
measure: Feasibility (active participation): Management of a targeted parent-child interaction situation
timeFrame: During the first and the last regular IPSA sessions (up to six months after baseline).
measure: Feasibility (potential harms): General perceived stress
timeFrame: At baseline (pre IPSA; T1) and immediately after the intervention (post IPSA; T2), as well as at follow-up (up to three months after program completion; T3).
measure: Feasibility (potential harms): Anxiety/Depression
timeFrame: At baseline (pre IPSA; T1) and immediately after the intervention (post IPSA; T2), as well as at follow-up (up to three months after program completion; T3).
measure: Feasibility (potential harms): Adverse Events and Serious Adverse Events
timeFrame: Up to the follow-up (up to three months after program completion).
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Institutet
Study officials:
affiliation: Karolinska Institutet
name: Tatja Hirvikoski, Ass. Prof.
role: PRINCIPAL_INVESTIGATOR
References: