A Randomized Controlled Trial of Improving Parenting Skills Adult ADHD (IPSA): A New Parent Training Program for Parents Who Themselves Have ADHD
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 109
- 试验地点
- 2
- 主要终点
- Parental Self-Efficacy
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
结局指标
主要结局
Parental Self-Efficacy
时间窗: 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).
Measured with the Parental Self-Efficacy scale (PSE; Ulfsdotter, Enebrink, \& Lindberg, 2014). Expected to change from pre to post IPSA. Higher scores mean better outcome.
次要结局
- Child behavior problems(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).)
- Parental Stress(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).)
- Household Disorganization/Home Chaos(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).)
研究者
Tatja Hirvikoski
Associate professor
Karolinska Institutet