Chronic IllnessesNCT03901027
FAM-SOTC Intervention for Families of Children With Chronic Illnesses
A study testing Therapeutic Conversation Interventions in people with Chronic Illnesses, run by University of Iceland.
Trial summary
Purpose: A growing number of families with children are dealing with chronic illnesses or health problems that places increased demand on the family. Nurses are in a core position to support and empower these families. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Illnesses
- What is being tested?
- Therapeutic Conversation Interventions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2015to 31 Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Being a parents of children/adolescents with diabetes, arthritis, epilepsy or sleeping disorder with ADHD who were in active treatment at a University Hospital.
- Parents needed to be fluent in the Icelandic language.
Who cannot join
- Parents who did not understand Icelandic or English.
- Parents who could not read or write at the 4th grade level.
About this study
Official title: The FAM-SOTC Intervention: Families of Children With Chronic Illnesses
Purpose: A growing number of families with children are dealing with chronic illnesses or health problems that places increased demand on the family. Nurses are in a core position to support and empower these families. The benefit of therapeutic conversation between nurses and families dealing with health problems have shown positive results and therefore received increasing attention. The aim of this study was to evaluate the benefits of two sessions of the Family Strength Oriented Therapeutic Conversation (FAM-SOTC) intervention, offered by advanced practice nurses (APN), for parents of children and adolescents with Juvenile idiopathic arthritis (JIA), epilepsy, diabetes, and with sleep disturbance with attention deficit hyperactivity disorder (ADHD).
Design: The effectiveness of the intervention was tested within a quasi-experimental study with one group pre- and-posttest design.
Method: The intervention was based on the Calgary family assessment and intervention models and the Illness Beliefs model and was offered in March 2015--December 2016. Parents (N=31) at the Children's Hospital at the National University Hospital of Iceland, got two sessions of the FAM-SOTC intervention focusing on emotional support, evidence based information and recommendations and on the strengths of family members.
Read the detailed description
Sample Data were collected at the Children's Hospital (CH) at the National University Hospital of Iceland (NUHI) in Reykjavik, Iceland. The population of Iceland is about 340,000 people. The incidence of diabetes among children in Iceland is 18 per year, and similar frequency among children and adolescents is reported regarding arthritis, epilepsy and sleeping disorder with ADHD. Participants in this study were 31 primary caregivers who all were the mothers of the children/adolescents with diabetes, arthritis, epilepsy or sleeping disorder with ADHD (see Table 1). A research assistant offered all the primary caregivers (N = 39; n=38 mothers and n=1 father) of children with one of the above-mentioned illnesses/disorders at the time of the data collection, to participate in the study. The 31 primary caregivers, who signed the consent form, participated in the study and represented 80% response rate. Parents completed online the questionaires at the clinic, before they started the first session and then again after the second session. Three APN ,specialists in the child illness diagnosis and who had special graduate educational training in family system nursing or had a doctorate degree in family nursing, offered the families the FAM-SOTC intervention. The parents meet with the APN at the Children´s Hospital without the child in both sessions, but each session lasted for 45 to 90 minutes. The sessions were offered with 4-8 weeks interval.
Description of the FAM-SOTC intervention The description of the development of the FAM-SOTC as well as a figure of the FAM-SOTC intervention, has been published elsewhere.
The first FAM-SOTC session:
When the APN had greeted the parents and made them comfortable, a family assessment was conducted by drawing a family tree and the quality of the family relations indicated, as well as asking them who belonged to their family. Therapeutic questions were used and parents asked questions like where they got support from? The parents were encouraged to talk about their child's illness experience and to reflect on how they perceived the diagnose of the child/adolescent. Further, the main concerns of each of the parent where explored by using therapeutic questions such as: (a) What is your greatest challenge now? and (b) If something could be different, what would that be? Throughout the therapeutic conversaton's the nurse acknowledge the suffering of each family member and normalized their emotional responses. The nurse than drew attention to the family strengths that had been observed. Potential resources were then discussed and the nurse offered advice and education. At the end of the therapeutic conversations the nurse again mentioned the parents strengths and resources and a time was set for the next appointment.
The second FAM-SOTC session:
In the second session a revision was made from the first session. Parents were encouraged to talk about their experience and change in their daily life and how the chronic illness or disorder affected them and the family as a unit. In addition, therapeutic questions were used such as (a) What is the greatest challenge facing your family now? (b) Who in your family do you think the illness has the most impact on? (c) What has been most/less helpful for you to do, to cope with the illness diagnose(s)? The parents were told what the APN had learned from their conversation, from their strengths and from their concerns. Furthermore, the parents emotional responses were acknowledge by telling them that their feelings and worries were normal for parents of children with chronic illnesses/disorders who were in similar situations'. Potential resources for each family were identified. Information and advice was offered and before finishing this session, parents were reminded of taking care of their own health and well-being.
Procedures Data were collected from March 2015 to december 2016 using online LimeSurvey program (a professional online survey). The parents signed an informed consent which was provided by a clinical nurse specialist on each of the units, who participated in the study. The parents were given a code to login to online LimeSurvey where they could fill out the questionnaires.
Ethical approval Approval for the study was received from the Scientific Ethical Board of the participating hospital (39/2014). A notification of the study was sent to the National Bioethics Committee in Iceland (S7110).
- Conditions
- Chronic Illnesses
- Being tested
- Therapeutic Conversation Interventions
- Keywords
- Parents, Children, Chronic Illnesses
- Medical subject headings
- Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic Conversation InterventionsBehavioural
Parents (N=31) at the Children's Hospital at the National University Hospital of Iceland, got two sessions of the FAM-SOTC intervention focusing on emotional support, evidence based information and recommendations and on the strengths of family members. The parents meet with the Advanced Practice Nurse at the Children´s Hospital without the child in both sessions, but each session lasted for 45 to 90 minutes. The sessions were offered with 4-8 weeks interval.
| Study group | Role | What they receive |
|---|---|---|
| Parents of children with chronic illnesses | Experimental | psycho-educational intervention for parents Receives: Behavioral: Therapeutic Conversation Interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
The ICE-Perceived Family Support from nurses Questionnaire (14-Items) at baseline
Has two factors: Cognitive (alpha=0.874) and emotional (alpha=0.937) support. Total alpha= 0.952. Has been reported to be both reliable and valid. The range of the scores is between 1-5. The total scale score range from 14-70, with higher score indicating better outcome.
Measured: 1 week
The ICE-Perceived Family Support from nurses Questionnaire (14-Items)
Has two factors: Cognitive (alpha=0.874) and emotional (alpha=0.937) support. Total alpha= 0.952. Has been reported to be both reliable and valid. The range of the scores is between 1-5. The total scale scores range from 14-70, with higher score indicating better outcome.
Measured: 8-10 weeks
The ICE-Family Illness Beliefs Questionnaire (7-Items) at baseline
I a one factor instrument regarding families illness beliefs. Alpha=0.789-0.910. The instrument has been reported to be both reliable and valid. The range of the scores is between 1-5. The total scale score range from 7-35, with higher score indicating better outcome.
Measured: 1 week
The ICE-Family Illness Beliefs Questionnaire (7-Items)
I a one factor instrument regarding families illness beliefs. Alpha=0.789-0.910. The instrument has been reported to be both reliable and valid. The range of the scores is between 1-5.
Measured: 8-10 weeks The total scale score range from 7-35, with higher score indicating better outcome.
Secondary outcomes (4)
the PedsQL-Family Impact Module (36-item) at baseline
The instrument assess the impact of pediatric chronic health conditions on parents and families. It includes 8 subscales regarding physical functioning, emotional functioning, social functioning, cognitive functioning, communications, worry, daily activities and family relationships. The instrument has been reported to be both valid and reliable and has been psychometrically tested with Cronbach's alpha of 0.970). The range of the scores is between 1-5. The total scale score range from 36-180, with higher score indicating better outcome.
Measured: 1 week
the PedsQL-Family Impact Module (36-item)
The instrument assess the impact of pediatric chronic healht conditions on parents and families. It includes 8 subscales regarding physical functioning, emotional functioning, social functioning, cognitive functioning, communications, worry, daily activities and family relationships. The instrument has been reported to be both valid and reliable and has been psychometrically tested with Cronbach's alpha of 0.970). The range of the scores is between 1-5. The total scale score range from 36-180, with higher score indicating better outcome.
Measured: 8-10 weeks
The PedsQL-Healthcare Satisfaction Generic Module (24-items) at baseline
The items are grouped into 6 domains associated with health care satisfaction: information, family inclusion, communication , technical skills, emotional needs and overall satisfaction. The instrument has been reported to be valid and has been psychometrically tested with cronbach´s alpha of 0.79. The range of the scores is between 1-5. The total scale score range from 24-120, with higher score indicating better outcome.
Measured: 1 week
The PedsQL-Healthcare Satisfaction Generic Module (24-items)
The items are grouped into 6 domains associated with health care satisfaction: information, family inclusion, communication , technical skills, emotional needs and overall satisfaction. The instrument has been reported to be valid and has been psychometrically tested with cronbach´s alpha of 0.79. The range of the scores is between 1-5. The total scale score range from 24-120, with higher score indicating better outcome.
Measured: 8-10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2019
- Study start1 Mar 2015
- Primary completion31 Dec 2016
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic IllnessesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The effectiveness of the intervention was tested within a quasi-experimental study with one group pre- and-posttest design.
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Iceland
- Sponsor type
- University, hospital or other
- Collaborators
- Landspitali University Hospital
- Responsible party
- Sponsor
- Investigators
- Ása Þórisdóttir, Study director, University of Iceland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03901027
- Sponsor's protocol ID
- UIceland-12019EKS
- Status last verified
- Apr 2019
- First submitted
- 20 Mar 2019
- Last updated
- 8 Apr 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The FAM-SOTC Intervention: Families of Children With Chronic Illnesses
- ClinicalTrials.gov ID
- NCT03901027
- Acronym / sponsor ID
- UIceland-12019EKS
- Conditions
- Chronic Illnesses
- Keywords
- Parents, Children, Chronic Illnesses
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of IcelandUniversity, hospital or other
- Collaborators
- Landspitali University Hospital
- Study start
- 1 Mar 2015 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 3 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Purpose: A growing number of families with children are dealing with chronic illnesses or health problems that places increased demand on the family. Nurses are in a core position to support and empower these families. The benefit of therapeutic conversation between nurses and families dealing with health problems have shown positive results and therefore received increasing attention. The aim of this study was to evaluate the benefits of two sessions of the Family Strength Oriented Therapeutic Conversation (FAM-SOTC) intervention, offered by advanced practice nurses (APN), for parents of children and adolescents with Juvenile idiopathic arthritis (JIA), epilepsy, diabetes, and with sleep disturbance with attention deficit hyperactivity disorder (ADHD).
Design: The effectiveness of the intervention was tested within a quasi-experimental study with one group pre- and-posttest design.
Method: The intervention was based on the Calgary family assessment and intervention models and the Illness Beliefs model and was offered in March 2015--December 2016. Parents (N=31) at the Children's Hospital at the National University Hospital of Iceland, got two sessions of the FAM-SOTC intervention focusing on emotional support, evidence based information and recommendations and on the strengths of family members.
Detailed description
Sample Data were collected at the Children's Hospital (CH) at the National University Hospital of Iceland (NUHI) in Reykjavik, Iceland. The population of Iceland is about 340,000 people. The incidence of diabetes among children in Iceland is 18 per year, and similar frequency among children and adolescents is reported regarding arthritis, epilepsy and sleeping disorder with ADHD. Participants in this study were 31 primary caregivers who all were the mothers of the children/adolescents with diabetes, arthritis, epilepsy or sleeping disorder with ADHD (see Table 1). A research assistant offered all the primary caregivers (N = 39; n=38 mothers and n=1 father) of children with one of the above-mentioned illnesses/disorders at the time of the data collection, to participate in the study. The 31 primary caregivers, who signed the consent form, participated in the study and represented 80% response rate. Parents completed online the questionaires at the clinic, before they started the first session and then again after the second session. Three APN ,specialists in the child illness diagnosis and who had special graduate educational training in family system nursing or had a doctorate degree in family nursing, offered the families the FAM-SOTC intervention. The parents meet with the APN at the Children´s Hospital without the child in both sessions, but each session lasted for 45 to 90 minutes. The sessions were offered with 4-8 weeks interval.
Description of the FAM-SOTC intervention The description of the development of the FAM-SOTC as well as a figure of the FAM-SOTC intervention, has been published elsewhere.
The first FAM-SOTC session:
When the APN had greeted the parents and made them comfortable, a family assessment was conducted by drawing a family tree and the quality of the family relations indicated, as well as asking them who belonged to their family. Therapeutic questions were used and parents asked questions like where they got support from? The parents were encouraged to talk about their child's illness experience and to reflect on how they perceived the diagnose of the child/adolescent. Further, the main concerns of each of the parent where explored by using therapeutic questions such as: (a) What is your greatest challenge now? and (b) If something could be different, what would that be? Throughout the therapeutic conversaton's the nurse acknowledge the suffering of each family member and normalized their emotional responses. The nurse than drew attention to the family strengths that had been observed. Potential resources were then discussed and the nurse offered advice and education. At the end of the therapeutic conversations the nurse again mentioned the parents strengths and resources and a time was set for the next appointment.
The second FAM-SOTC session:
In the second session a revision was made from the first session. Parents were encouraged to talk about their experience and change in their daily life and how the chronic illness or disorder affected them and the family as a unit. In addition, therapeutic questions were used such as (a) What is the greatest challenge facing your family now? (b) Who in your family do you think the illness has the most impact on? (c) What has been most/less helpful for you to do, to cope with the illness diagnose(s)? The parents were told what the APN had learned from their conversation, from their strengths and from their concerns. Furthermore, the parents emotional responses were acknowledge by telling them that their feelings and worries were normal for parents of children with chronic illnesses/disorders who were in similar situations'. Potential resources for each family were identified. Information and advice was offered and before finishing this session, parents were reminded of taking care of their own health and well-being.
Procedures Data were collected from March 2015 to december 2016 using online LimeSurvey program (a professional online survey). The parents signed an informed consent which was provided by a clinical nurse specialist on each of the units, who participated in the study. The parents were given a code to login to online LimeSurvey where they could fill out the questionnaires.
Ethical approval Approval for the study was received from the Scientific Ethical Board of the participating hospital (39/2014). A notification of the study was sent to the National Bioethics Committee in Iceland (S7110).
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The effectiveness of the intervention was tested within a quasi-experimental study with one group pre- and-posttest design.
| Arm | Type | Receives |
|---|---|---|
| Parents of children with chronic illnesses | Experimental | Behavioral: Therapeutic Conversation Interventionspsycho-educational intervention for parents |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Being a parents of children/adolescents with diabetes, arthritis, epilepsy or sleeping disorder with ADHD who were in active treatment at a University Hospital.
- Parents needed to be fluent in the Icelandic language.
Key exclusion criteria (2 listed)
- Parents who did not understand Icelandic or English.
- Parents who could not read or write at the 4th grade level.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therapeutic Conversation InterventionsParents (N=31) at the Children's Hospital at the National University Hospital of Iceland, got two sessions of the FAM-SOTC intervention focusing on emotional support, evidence based information and recommendations and on the strengths of family members. The parents meet with the Advanced Practice Nurse at the Children´s Hospital without the child in both sessions, but each session lasted for 45 to 90 minutes. The sessions were offered with 4-8 weeks interval. | Behavioural | Parents of children with chronic illnesses |
Primary outcome
The ICE-Perceived Family Support from nurses Questionnaire (14-Items) at baseline
Time frame: 1 week
Has two factors: Cognitive (alpha=0.874) and emotional (alpha=0.937) support. Total alpha= 0.952. Has been reported to be both reliable and valid. The range of the scores is between 1-5. The total scale score range from 14-70, with higher score indicating better outcome.
The ICE-Perceived Family Support from nurses Questionnaire (14-Items)
Time frame: 8-10 weeks
Has two factors: Cognitive (alpha=0.874) and emotional (alpha=0.937) support. Total alpha= 0.952. Has been reported to be both reliable and valid. The range of the scores is between 1-5. The total scale scores range from 14-70, with higher score indicating better outcome.
The ICE-Family Illness Beliefs Questionnaire (7-Items) at baseline
Time frame: 1 week
I a one factor instrument regarding families illness beliefs. Alpha=0.789-0.910. The instrument has been reported to be both reliable and valid. The range of the scores is between 1-5. The total scale score range from 7-35, with higher score indicating better outcome.
The ICE-Family Illness Beliefs Questionnaire (7-Items)
Time frame: 8-10 weeks The total scale score range from 7-35, with higher score indicating better outcome.
I a one factor instrument regarding families illness beliefs. Alpha=0.789-0.910. The instrument has been reported to be both reliable and valid. The range of the scores is between 1-5.
4 secondary outcomes
the PedsQL-Family Impact Module (36-item) at baseline
Time frame: 1 week
the PedsQL-Family Impact Module (36-item)
Time frame: 8-10 weeks
The PedsQL-Healthcare Satisfaction Generic Module (24-items) at baseline
Time frame: 1 week
The PedsQL-Healthcare Satisfaction Generic Module (24-items)
Time frame: 8-10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ása Þórisdóttir study director
University of Iceland
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic Conversation Interventions in people with Chronic Illnesses, run by University of Iceland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The ICE-Perceived Family Support from nurses Questionnaire (14-Items) at baseline (time frame: 1 week). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2019.