Evaluation of the Feasibility of Family Strength-oriented Therapy Conversation for Families of 13-18 Years Old Adolescents With Attention-Deficit/Hyperactivity Disorder, at the Child and Adolescent Outpatient Unit: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Treatment Evaluation Questionnaire
研究概览
简要总结
Attention-deficit/hyperactivity disorder (ADHD), is a highly genetic and complex neurological disorder, where disruptive behavior, emotional imbalance, and lack of attention can interrupt with normal development of adolescents, self-awareness, and self-regulation in a way that has an impact on the family unit. Effective family intervention programs, that empower resilience and strength, to cope with the stressful situation from ADHD, are therefore needed. Nevertheless, there is a lack of knowledge regarding what type of interventions are the most effective for these families. As well as, little is known about the benefits of family-level intervention for families of adolescents with ADHD at outpatient care and what amount of combination in an intervention is appropriate. Psychiatric advanced practical nurse (APN) practitioners are in a key role to offer such an intervention. Therefore, the aim of this pilot study is to evaluate the feasibility of offering a family-level intervention, for parents of 13-17 years old adolescents with ADHD, at a Children and Adolescents' Psychiatric Outpatient Unit (BUGL). Also, to evaluate if the intervention, which consists of group educational sessions, family sessions, and access to evidence-based information's on ADHD, fitted the families.
A nurse-led educational and support intervention will be offered for parents of adolescents with ADHD once a week over a 5-week time period. First, there will be offered three group support sessions, with information about the general impact of the ADHD disorder on the family's daily life. Second, two special therapeutic conversations and support interviews will be offered to each family, where each parent can discuss their daily situation specifically and its impact on the family as a whole. Third, caregivers will have access to about 140 pages of evidence-based material on a closed website (pan pale) regarding the ADHD disorder in adolescents and its impact on the family.
The outcome of this process will help in determining the feasibility of subjecting the intervention to a more expensive and time-consuming randomized controlled trial (RCT) study.
详细描述
A pilot study is a cornerstone to represent many methodological design challenges when studying a vulnerable group of parents or when testing the feasibility of an intervention. Attrition of dropout is one of the most crucial components in intervention research for families of adolescents in third-line care as for families of adolescents with ADHD. Furthermore, motivation is important to keep parents engaged, as well as to minimize the risk of them dropping out of the study. In a pilot study, questions are asked regarding if the intervention can be done, and it is determined whether an intervention warrants further testing, and if so, how. This special design then elements the study as a small-scale study, before the main full-size study will be conducted. Further, this design of a study is also done to improve the quality, to evaluate the safety of the intervention, to re-evaluate the recruitment possibilities as well as to considering ethical aspects of a larger randomized control trial (RCT) study. This pilot study is therefore conducted to assess the feasibility of a 5-week Family strength-oriented therapy conversation (FAM-SOTC) intervention in an RCT. Preliminary research is used to assess the process, resources, management, and scientific value. This is an important factor in increasing the efficiency and results of future RCTs and preventing wasted time and resources.
From November 2018 until March 2019, will caregivers of adolescents aged 13-18 with a diagnosis of ADHD at BUGL be randomly selected and invited to participate in the study. Inclusion criteria for family participation are (a) adolescents diagnosed with ADHD at BUGL and (b) born between 2001 and 2007. (c) Caregivers needed to speak and read fluent Icelandic and (d) be living close to the capital city. Exclusion criteria are (a) caregivers not speaking or reading fluent Icelandic and (b) the family living in the countryside
The FAM-SOTC intervention emphasizes the family's strength and resilience, empowering parents of adolescents with ADHD to support themselves and their child. The FAM-SOTC requires nurses to build trust in the therapeutic relationship, listen to families, reflect on therapeutic questions, and offer appropriate evidence-based information and guidelines. The FAM-SOTC is based on the Calgary family assessment model (CFAM) and Calgary family intervention model (CFIM), as well as the illness beliefs model (IBM), which views suffering as stemming from the beliefs about the illness, but not the illness itself. Addressing beliefs about the illness presents a new path for helping families to handle stressful situations. In addition, Barkley's clinical manual for family assessment and intervention are used to guide caregivers step-by-step in how to deal with demanding ADHD symptoms. Clinical advice will be given to strengthen the supportive role of parents to improve the parent-teen relationship and the adolescent's adjustment.
The 5-week family strength-oriented therapeutic conversation intervention proceeded as follows: caregivers will be invited to participate once a week over a 5-week time period. First, a two-hour ADHD educational and psychosocial group support sessions will be held for caregivers (five families in a group, one per week over a 3-week period) that included general ADHD information, a 10-step process for supporting adolescents in a positive, constructive way, and problem-solving exercises to practice in the group and at home (a total of six hours of educational and psychosocial support sessions). Second, APNs led special therapeutic conversations and provided individualized support for each family (once a week for 2 weeks; 60-90 min each section, resulting in 2-3 hours of support for each family). The individualized support emerged from the therapeutic relationship and family relations and allowed caregivers to tell their narrative illness stories. Therapeutic questions are used for assessment (CFAM) of caregivers' strengths, resiliency, and resources to understand their need for further guidance and to recommend interventions (build on the CFIM) to identify facilitate and/or constrain beliefs. Thereby, the FAM-SOTC can strengthen family functioning, well-being, illness beliefs, and family support. Third, over the whole study period, parents received access to a website with about 140 pages of evidence-based (EB) - educational and informative material to be used as they wished.
At the beginning of the study, participants will provide written informed consent with agreeing to participate. Data will be collected with accurate, reliable questionnaires through the research electronic data capture (REDCap) data management platform. Caregivers and adolescents answer different questionnaires at the same time. The baseline measurement is taken at time one (t1) before caregivers received the intervention, and follow-up questionnaires are given at time two (t2) after the intervention (post-intervention), 5-weeks from baseline (t1).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(a) Adolescents, aged 13-17 diagnosed with ADHD at a Children's and Adolescent's Psychiatric unit at Landspitali - The National University Hospital of Iceland (BUGL). (b) Born between 2001 and
- •(c) Caregivers needed to speak and read fluent Icelandic and (d) be living close to the capital city.
排除标准
- •(a) Caregivers do not speak or read fluent Icelandic and (b) the family live in the countryside.
结局指标
主要结局
Treatment Evaluation Questionnaire
时间窗: T2 (post-intervention in experimental group, 6 weeks after baseline).
Caregivers answered a questionnaire regarding group care giving sessions and individual care giving sessions regarding education, conversation, tasks, and support. Answers to the questionnaire are either given as yes/no, open answers or a 5-point scale with a scoring range from 1 to 5; a higher score indicates a more positive experience.
Iceland-Expressive Family Functioning Questionnaire (ICE-EFFQ).
时间窗: T2 (post-intervention in experimental group, 6 weeks after baseline).
ICE-EFFQ is a 17-item instrument within four categories: emotions, collaboration and problem-solving, communication and behavior. The questionnaire is a 5-point scale with a scoring range from 1 to 5; a higher score indicates a good family function.
Disruptive Behavior Rating Scale (DBRS)
时间窗: T2 (post-intervention in experimental group, 6 weeks after baseline).
The DBRS is an 8-statement rating-scale were parents list the symptoms of op-positional defiant disorder (ODD) and conduct disorder (CD). The scale is with a scoring range from 0 to 4; a higher score indicates more anti-developmental disorder.
Perlin´s Self-Mastery Scale
时间窗: T2 (post-intervention in experimental group, 6 weeks after baseline).
The Mastery scale is a 7-items questionnaire for adolescents. It is a 4-point scale format ranging from strongly agree to strongly disagree. A higher score indicates a better mastery.
Iceland-Family Perceived Support Questionnaire (ICE- FPSQ).
时间窗: T2 (post-intervention in experimental group, 6 weeks from T1)
The ICE-FPSQ is a 14-item questionnaire about support and education perceived from nurses within of two categories: cognitive and emotional support. It uses a scale with a scoring from 1-5; the higher scores indicate a better family function.
Rosenberg Self-Esteem Scale
时间窗: T2 (post-intervention in experimental group, 6 weeks after baseline).
The Rosenberg Self-Esteem scale is a 10-item questionnaire for adolescents that measures self-worth by measuring both positive and negative feelings about the self-esteem. It is a 4-point scale format ranging from strongly agree to strongly disagree. Higher scores indicate higher self-esteem of positive thinking for building resilience.
The General Well-Being Schedule (GWBS)
时间窗: T2 (post-intervention in experimental group, 6 weeks after baseline).
GWBS is an 18-item instrument measuring positive and negative feelings: anxiety, depression, general health, positive well-being, self-control and vitality. The first 14 questions are 6-point scale (1=all of the time, 6=none of the time) and questions 15-18 are 1-10-point rating scales defined by adjectives feeling at each end.
Iceland-Family Illness Beliefs Questionnaire (ICE-FIBQ)
时间窗: T1 (at baseline in experimental group).
The ICE-FIBQ is a 7-item instrument that measure beliefs regarding illnesses among families who had members suffering from long-term illnesses. The questionnaire is a 5-point scale; higher scores indicate more reassurance regarding caregiver beliefs.
Iceland-Family Illness Beliefs Questionnaire (ICE-FIBQ).
时间窗: T2 (post-intervention in experimental group, 6 weeks from T1).
The ICE-FIBQ is a 7-item instrument that measure beliefs regarding illnesses among families who had members suffering from long-term illnesses. The questionnaire is a 5-point scale; higher scores indicate more reassurance regarding caregiver beliefs.
Coping health inventory for parents (CHIP)
时间窗: T2 (post-intervention in experimental group, 6 weeks after baseline).
The CHIP measures parental coping patterns when parents have a child who is seriously and/or chronically ill. The CHIP comprises three sub-scales (dimensions) measuring three different coping patterns: a) maintaining family integration, co-operation, and an optimistic definition of the situation; b) maintaining social support, self-esteem, and psychological stability; and c) understanding the healthcare situation through communication with other parents and consultation with the healthcare team. The questionnaire is a 5-point scale; higher scores indicate more coping ability.
The PedsQL-Family Impact Module.
时间窗: T2 (post-intervention in experimental group, 6 weeks after baseline).
The Family Impact Module is an instrument of 37 items that measures family's quality of life. Eight sub-scales of parents functioning that compact physical, emotional, social, cognitive, communications, worrying, daily activity and relationships in the family. It is scale with a scoring range from 0 to 4; a higher score indicates a better quality of life.
Background questionnaire for adolescents'
时间窗: T1 (at baseline in experimental group).
Questions about gender, age, school and work. Mostly open-ended questions.
Attention-deficit Hyperactivity Disorder Rating Scale - IV (ADHD-RS)
时间窗: T2 (post-intervention in experimental group, 6 weeks after baseline).
The ADHD-RS a checklist for children aged 5-17 years old for diagnosing ADHD in DSM-IV and ICD-10. The questionnaire has 18 items that consists of two sub-scales: in attention (9 items) and hyperactivity-impulsivity (9 items). Higher score indicates more symptoms.
Background for parents questionnaire
时间窗: T1 (at baseline in experimental group).
Questions about gender, age, education, work, family status, diagnoses, other psychological treatments. Mostly open-ended questions.
次要结局
未报告次要终点
研究者
Erla Kolbrún Svavarsdóttir
professor
University of Iceland