Evaluating the Feasibility of FAM-SOTC Intervention for Families of Adolescents With ADHD: Pilot Study

NCT04378517 | Completed DMC

• 1 other identifier: UI-2019_ADHD-pilotstudy
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Attention Deficit Hyperactivity Disorder Combined

Keywords

ADHD; adolescents; advanced psychiatric nursing; caregivers; family strength therapeutic conversation; psychosocial education; psychosocial support

Outcome Measures

Primary Outcomes (23)

• Iceland-Family Perceived Support Questionnaire (ICE- FPSQ).

  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.

  T1 (at baseline in experimental group).

• Iceland-Family Perceived Support Questionnaire (ICE- FPSQ).

  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.

  T2 (post-intervention in experimental group, 6 weeks from T1)

• Iceland-Family Illness Beliefs Questionnaire (ICE-FIBQ)

  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.

  T1 (at baseline in experimental group).

• Iceland-Family Illness Beliefs Questionnaire (ICE-FIBQ).

  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.

  T2 (post-intervention in experimental group, 6 weeks from T1).

• Iceland-Expressive Family Functioning Questionnaire (ICE-EFFQ).

  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.

  T1 (at baseline in experimental group).

• Iceland-Expressive Family Functioning Questionnaire (ICE-EFFQ).

  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.

  T2 (post-intervention in experimental group, 6 weeks after baseline).

• Treatment Evaluation Questionnaire

  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.

  T2 (post-intervention in experimental group, 6 weeks after baseline).

• Coping health inventory for parents (CHIP)

  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.

  T1 (at baseline in experimental group).

• Coping health inventory for parents (CHIP)

  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.

  T2 (post-intervention in experimental group, 6 weeks after baseline).

• The General Well-Being Schedule (GWBS)

  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.

  T1 (at baseline in experimental group).

• The General Well-Being Schedule (GWBS)

  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.

  T2 (post-intervention in experimental group, 6 weeks after baseline).

• The PedsQL-Family Impact Module.

  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.

  T1 (at baseline in experimental group).

• The PedsQL-Family Impact Module.

  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.

  T2 (post-intervention in experimental group, 6 weeks after baseline).

• Attention-deficit Hyperactivity Disorder Rating Scale - IV (ADHD-RS)

  The ADHD-RS a checklist for children aged 5-17 years old for diagnosing ADHD in the classification found in the Diagnostic and Statistical Manual of Mental Disorder, 4th Edition (DSM-IV) and/or in the 10th revision of the International Statistical Classification of Diseases (ICD-10). The questionnaire has 18 items that consists of two subscales: in attention (9 items) and hyperactivity-impulsivity (9 items). Higher score indicates more symptoms.

  T1 (at baseline in experimental group).

• Attention-deficit Hyperactivity Disorder Rating Scale - IV (ADHD-RS)

  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.

  T2 (post-intervention in experimental group, 6 weeks after baseline).

• Disruptive Behavior Rating Scale (DBRS)

  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.

  T1 (at baseline in experimental group).

• Disruptive Behavior Rating Scale (DBRS)

  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.

  T2 (post-intervention in experimental group, 6 weeks after baseline).

• Rosenberg Self-Esteem Scale

  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.

  T1 (at baseline in experimental group).

• Rosenberg Self-Esteem Scale

  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.

  T2 (post-intervention in experimental group, 6 weeks after baseline).

• Perlin´s Self-Mastery Scale

  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.

  T1 (at baseline in experimental group).

• Perlin´s Self-Mastery Scale

  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.

  T2 (post-intervention in experimental group, 6 weeks after baseline).

• Background for parents questionnaire

  Questions about gender, age, education, work, family status, diagnoses, other psychological treatments. Mostly open-ended questions.

  T1 (at baseline in experimental group).

• Background questionnaire for adolescents'

  Questions about gender, age, school and work. Mostly open-ended questions.

  T1 (at baseline in experimental group).

Study Arms (1)

ADHD FAM-SOTC support: A Pilot Study

OTHER

Phase-I, a pilot study to evaluate the feasibility of offering a 5-week intervention for families of adolescents diagnosed with ADHD at BUGL. The outcome helps to determining the feasibility of subjecting the intervention to a more rigour and a more expensive and time-consuming RCT. Phase-II and III are an RCTs to determine the benefit of a FAM-SOTC intervention: Is there a significant difference in the impact of FAM-SOTC intervention: From caregiver's perspective (phase II) on the experience of support for, family functioning, believes, coping patterns, general well-being, parental adaptation and parental assessment of ADHD symptoms and adolescent developmental disruptive behaviour, compared to caregivers receiving delayed treatment? From adolescents' perspective (Phase-III) in the assessment of adolescents own self-awareness and self-esteem, after their parents receive FAM-SOTC intervention, compared to a group of adolescents where caregivers receive delayed treatment?

Other: psychosocial education in parents groups; Other: psychosocial parents support, interviews with APN

Interventions

psychosocial education in parents groups OTHER

psychosocial education

ADHD FAM-SOTC support: A Pilot Study

psychosocial parents support, interviews with APN OTHER

Family strength-oriented therapy conversation

ADHD FAM-SOTC support: A Pilot Study

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

Sponsors & Collaborators

• University of Iceland: lead

Study Sites (1)

University of Iceland, Faculty of Nursing

Reykjavik, Iceland

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Interviews as Topic

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Ása V Þórisdóttir, PhD

  University of Iceland

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Model Details: Pilot-study

Study Record Dates

• First Submitted: May 4, 2020
• First Posted: May 7, 2020
• Study Start: November 13, 2018
• Primary Completion: February 20, 2019
• Study Completion: March 27, 2019
• Last Updated: February 21, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

IC (1)