Evaluating the Feasibility of FAM-SOTC Intervention for Families of Adolescents With ADHD: Pilot Study
Condition: Attention Deficit Hyperactivity Disorder Combined
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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).

      The following instruments will be used for caregivers to measure their satisfaction and
      changes in their adolescents' ADHD symptoms: family-support (ICE-FPSQ); illness beliefs
      (ICE-FIBQ); family-activity (ICE-EFFQ); coping health inventory for parents (CHIP); the
      general well-being schedule (GWB); treatment evaluation questionnaire (TEQ); paediatric
      quality of life questionnaire (PedsQL); ADHD Rating Scale-IV (ADHD-RS); adolescents
      Disruptive Behaviour Rating Scale (DBRS); and background list in which information about
      gender, age, education, work, family status, diagnoses, and other psychological treatment are
      selected. The instruments for the adolescents to measure their self-esteem and mastery before
      and after their parents received the intervention are the Rosenberg Self-Esteem scale (50)
      and the Perlin et.al Mastery scale, in addition to a background questionnaire in which
      information about gender, age and education will be recorded.

      Data analysis are based on Polit and Beck's implementation of descriptive statistics: 1)
      determine how many will agree to participate, 2) calculate median (the middle number) and
      interquartile range (IQR) (IQR = Q3-Q1, a measure of the spread of the number of sessions
      completed and mean length of time to complete the data collection form), 3) compute effect
      sizes and confidence intervals around estimates, 4) assess whether, for each person a
      reliable improvement will occur, 5) determine whether, a clinically significant change will
      occur in a responder analysis, 6) assess whether changes and benchmarks will be established
      to decide the feasibility, or if larger research is needed for the results to be deemed
      meaningful.

      Ethic guidelines from the International Council of Nursing for ethical principles with human
      beings will be used. Before families agree to participate in the study, they receive an email
      with information about their role in the research, the nature of the study, and data
      collection. In addition, they will receive contact information from a psychiatrist, in case
      if they will experience discomfort with participating. Those that can not participate when
      invited have the opportunity to participate later and those that chose to receive the
      intervention but not answer the questionnaires will receive the intervention without
      participating in the study. Participating in the study has no effect on other treatment
      offered at the Psychiatric Unit; participants received the treatment as usual.

      This feasibility study will help assess whether it is worth evaluating the 5-week FAM-SOTC
      intervention in a larger RCT study. As well as, representing methodological challenges for
      these families in a combination with a protocol of educational and support program for
      families of adolescents with ADHD to enhance adolescents' self-management behaviors. The
      results will be of interest to health care professionals working with ADHD adolescents
      patients. Additionally, our study will be of value to user organizations and policymakers
      administering education and support programs aimed at the prevention and treatment of ADHD in
      adolescents. In a way, to encouraging and empowering parents of adolescents wiht ADHD at
      psychiatric outpatient unit in their parenting caring role that can affect the families as a
      whole in a positive way.
    

Intervention name(s): psychosocial education in parents groups; psychosocial parents support, interviews with APN
Intervention type(s): Other; Other
Intervention description(s): psychosocial education; Family strength-oriented therapy conversation
Intervention model: Single Group Assignment
Intervention model description: Pilot-study
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ADHD; adolescents; advanced psychiatric nursing; caregivers; family strength therapeutic conversation; psychosocial education; psychosocial support