ParentsNCT05940168
Internet-delivered ACT (I-Navigator ACT) for Parents of Children With Disabilities
A study testing I-Navigator ACT and Navigator ACT group in people with Parents and Stress, Psychological, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
The purpose of the project is to evaluate the feasibility, acceptability, and effectiveness of the internet-delivered Acceptance and Commitment Therapy treatment (I-Navigator ACT) for parents who experience stress, distress, depression or anxiety that may be associated with being a parent of a child with disabilities. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parents, Stress, Psychological, Anxiety
- What is being tested?
- I-Navigator ACT and Navigator ACT group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 1 siteSweden
- Study dates
- 1 Feb 2021to 30 Nov 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being a parent of at least one child (4-17 years of age) with any or several of the following disabilities: autism spectrum disorder, attention deficit hyperactivity disorder, intellectual disability, physical disability (eg cerebral palsy), traumatic brain injury and/or a profund and multiple intellectual disability (PMID)
- Experiencing stress, distress, depression and/or anxiety that to some extent may be associated with being a parent of a child with a disability
- Having access to a personal computer or tablet with a stable internet connection
- In Study 2 (RCT) also: being able to participate in the group treatment OR the internet-delivered treatment
Who cannot join
- Currently experiencing a serious mental disorder (eg ongoing psychosis, acute suicidal behaviours) or currently being treated at an in-patient mental health facility
- Not experiencing stress, distress, depression and/or anxiety that to some extent may be associated with being a parent of a child with a disability
- Not being able to read, write or speak the Swedish language
- Not being able to participate in all planned sessions
- Not having access to a personal computer or tablet with a stable internet connection
- In Study 2 (RCT) also: not being able to participate in the group treatment OR the internet-delivered treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility, Effectiveness and Qualitative Experiences of Internet-delivered ACT for Parents of Children With Disabilities
The purpose of the project is to evaluate the feasibility, acceptability, and effectiveness of the internet-delivered Acceptance and Commitment Therapy treatment (I-Navigator ACT) for parents who experience stress, distress, depression or anxiety that may be associated with being a parent of a child with disabilities. The project consists of three studies:
Study 1: An open feasibility trial in which parents participate in an individual, clinician-supported internet-delivered Acceptance and Commitment Therapy treatment.
Read more
Study 2: A randomized controlled trial in which participants are randomly assigned either:
- Navigator ACT group treatment, where parents participate in an Acceptance and Commitment Therapy group together with other parents, led by two group leaders, or
- I-Navigator ACT internet-delivered Acceptance and Commitment Therapy treatment, where the parent participates on their own, coached by a clinician via a message function.
Study 3: A qualitative study in which a smaller sample of parents from the open feasibility trial participate in semi-structured interviews. The interviews take place after the parents have completed I-Navigator ACT.
All three studies are conducted in a clinical health care context.
Read the detailed description
Internet Navigator ACT (I-Navigator ACT) is an individual, internet-delivered Acceptance and Commitment Therapy (ACT) treatment, adapted from the manualized ACT group Navigator ACT for parents of children with disabilities. The purpose of I-Navigator ACT is to provide a treatment option that isn't bound by geography, especially beneficial for patients who have limited access to in-person support and care. I-Navigator ACT was developed with a co-creation approach, which included pilot testing with a small group of parents to gather their detailed feedback. Their feedback was considered for refining the treatment.
I-Navigator ACT consists of ten online modules with different themes based on ACT processes. Participants receive weekly written support from an experienced clinician (coach), via a message function. The program is available through the Swedish national platform for internet-delivered treatments (1177.se).
There are three studies planned in this project. The first study (Study 1) will be conducted as a open feasibility trial, in which all participating parents after enrolment and inclusion (via telephone or video call) will be allocated to the I-Navigator ACT treatment. The main purpose of this study is to evaluate feasibility and acceptability of the treatment. Feasibility is measured through treatment completion, treatment credibility and expectation, as well as treatment satisfaction. Preliminary outcomes regarding effectiveness will also be evaluated in this study. Participants are being assessed at pre-treatment, post-treatment, and three months post-treatment.
The second study (Study 2) will be conducted as a randomized controlled trial with two treatment arms. The randomized controlled trial is conducted to evaluate the effectiveness of the I-Navigator ACT treatment compared to the Navigator ACT group treatment. After enrolment and screening via telephone or video call, eligible participants are invited to an information meeting. Once the participants have given their informed consent and completed pre-treatment assessments, they are randomly assigned either the five-session Navigator ACT group, or the I-Navigator ACT treatment. The treatments run parallel during the same semester, and participants are being assessed at the same time points (pre-treatment, post-treatment, and three months post treatment). Effectiveness will be evaluated through the primary outcome measure of acceptance and action-based skills, and secondary outcome measures parental stress, depression and anxiety symptoms, experiential avoidance, mindfulness-based skills, and parent-rated child behavioral problems.
The third and final study (Study 3) will be a qualitative study based on semi-structured interviews, and will be utilizing a thematic content analysis. The interviews will mainly focus on the experience of participating in an internet-delivered ACT treatment for parents.
Data collection commenced in early spring of 2021 (beginning with the open feasibility study) and is projected to be completed by November 2023. N = 32 participants have been allocated to treatment in the open feasibility study, whereas n = 134 participants have been allocated to treatment in the RCT. Nine parents have participated in qualitative interviews.
- Conditions
- Parents, Stress, Psychological, Anxiety, Depression, Neurodevelopmental Disorders, Autism Spectrum Disorder
- Being tested
- I-Navigator ACT, Navigator ACT group
- Keywords
- Acceptance and Commitment Therapy, Mindfulness, Experiential avoidance, Autistic children, Parental stress, Disability, Mental health, Telehealth, Internet delivered treatment, Randomized controlled trial, Group therapy, Families, Qualitative study, Interviews
- Medical subject headings
- Stress, Psychological, Anxiety Disorders, Depression, Neurodevelopmental Disorders, Autism Spectrum Disorder, Attention Deficit Disorder with Hyperactivity, Intellectual Disability, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
I-Navigator ACTBehavioural
The intervention is an internet-delivered ten module Acceptance and Commitment Therapy treatment program for stressed and distressed parents of children with disabilities. The contents of the program is mostly text based, but also includes videos, mindfulness exercises and written exercises, as well as homework between modules.
Navigator ACT groupBehavioural
The intervention is a five session Acceptance and Commitment Therapy group treatment for stressed and distressed parents of children with disabilities. All five sessions have different themes and are held by two group leaders. Sessions are around two and a half hours long. Homework is given between sessions.
| Study group | Role | What they receive |
|---|---|---|
| Navigator ACT group | Active comparator | This is a manualized Acceptance and Commitment Therapy group-intervention for 8-16 parents of children with disabilities. The intervention consists of five group sessions with different themes, as well as a booster-session at three months after the fifth session. The intervention is held by two group leaders. Receives: Behavioral: Navigator ACT group |
| I-Navigator ACT | Experimental | This intervention is an internet-delivered version of the manualized Acceptance and Commitment Therapy group. The internet-delivered version is given as an individual treatment via a secure online treatment platform. It consists of ten separate chapters or modules. The duration of the intervention is 10-12 weeks, with a individual follow up-session by phone or video at three months after completion. Receives: Behavioral: I-Navigator ACT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study 1: Treatment completion rate
In this feasibility study (study 1), treatment completion is defined as completing 7 out of 10 intervention sessions/modules. The benchmark for good feasibility is 75% of participants completing the treatment.
Measured: Participants are assessed during the 10-12 weeks long treatment.
Study 2: Changes in parental psychological flexibility and experiential acceptance
Parental Acceptance and Action Questionnaire (PAAQ), a scale that targets psychological flexibility and experiential acceptance in the parenting context, i.e., measures to which extent parents' accept inner experiences related to parenting and the readiness to take appropriate and needed action in parenting (commitment to values-based actions). This was originally a 19-item scale.
Measured: Participants are assessed at the time of inclusion, circa two weeks prior to the beginning of the intervention (T1), post-treatment, at the time of completing the intervention (T2), and at around three months after completing the intervention (T3)
Study 3: Experiences of participating in an internet-delivered ACT treatment for parents
The semi-structured interviews with parents after they have participated in the I-Navigator ACT treatment are based on the following seven interview questions:
- How was your experience participating in I-Navigator ACT?
- What aspects of the treatment did you appreciate?
- What aspects of the treatment did you appreciate less?
- Have you noticed any changes in your life, or everyday life after going through the treatment? Could you describe them?
- What aspects of the treatment do you think will be useful to you?
- What would you like to change about the treatment?
- If you were given the possibility to participate in the treatment but in a different format, eg in a group context, or one-on-one with your care provider in a physical room, what do you think would have been different, and what would be quite similar to your experience? How do you think you would find that?
Measured: The interviews are conducted after (circa 3 months) parents have participated in the I-Navigator ACT treatment.
Secondary outcomes (10)
Study 1: Changes in general stress and parental stress
Participants levels of stress and distress are assessed through the Parental Stress Scale (PSS), which is a 18-item psychometric scale (scored 1-5, where 1 indicates that the participant "Completely disagrees" with the statement and 5 indicates that the participant "Completely agrees" with the statement). Low scores indicate low levels of parental stress, whereas high scores indicate high levels of parental stress.
Another measure of stress is the Perceived Stress Scale 4 Items (PSS-4), which is a 4-item psychometric scale (scored 0-4, where 0 indicates "Never" and 4 indicates "Very often"). Low scores indicate low levels of stress, whereas high scores indicate high levels of stress.
The PSS measurement scale targets the specific kind of stress experienced by many parents, especially the stress experienced by parents of children with psychological/behavioral problems and children with disabilities. The PSS-4 measurement scale is designed to measure common stress symptoms.
Measured: Participants are assessed at the time of inclusion, circa two weeks prior to the beginning of the intervention (T1), post-treatment, at the time of completing the intervention (T2), and at around three months after completing the intervention (T3)
Study 1: Changes in depression and anxiety symptoms
The Hospital Anxiety and Depression Scale (HADS) consists of 14 items (scored 0-4, where 0 - "Often", and 4 - "Never"), subsequently summarized for an overall score. Low scores indicate none or very mild depressive and/or anxiety symptoms, whereas high scores indicate clinical levels of severe depression and or/anxiety.
Measured: Participants are assessed at the time of inclusion, circa two weeks prior to the beginning of the intervention (T1), post-treatment, at the time of completing the intervention (T2), and at around three months after completing the intervention (T3)
Study 1: Changes in mindfulness-based skills
The Mindfulness Awareness Attention Scale (MAAS), a 15-item scale (scored 1-6, where 1 indicates "Almost always" and 7 indicates "Never") assessing dispositional mindfulness in regards to cognitive, emotional, physical, interpersonal and general domains.
Measured: Participants are assessed at the time of inclusion, circa two weeks prior to the beginning of the intervention (T1), post-treatment, at the time of completing the intervention (T2), and at around three months after completing the intervention (T3)
Study 1: Changes in psychological flexibility and experiential acceptance
The AAQ assessment is intended to measure psychological flexibility and experiential acceptance in a general context. It intends to measure to which extent one accepts inner experiences, and the readiness to take appropriate and needed action in one's life (commitment to values-based actions). AAQ is a 7-item psychometric scale (scored 1-7, where 1 indicates "Never true" and 7 indicates "Always true").
Measured: Participants are assessed at the time of inclusion, circa two weeks prior to the beginning of the intervention (T1), post-treatment, at the time of completing the intervention (T2), and at around three months after completing the intervention (T3)
Study 1: Change in child's difficulties and the impact of these difficulties on the child's family
The Strengths and Difficulties Questionnaire (P4-17 SDQ), a caregiver administered, 25-item extended version of SDQ used for behavior screening of children and adolescents in ages 4-17 years. The SDQ P4-17 covers common areas of emotional and behavioral difficulties and strengths. It also includes a caregiver reported impact and burden assessment.
Measured: Participants are assessed at the time of inclusion, circa two weeks prior to the beginning of the intervention (T1), post-treatment, at the time of completing the intervention (T2), and at around three months after completing the intervention (T3)
Study 2: Changes in general stress and parental stress
Participants levels of stress and distress are assessed through the Parental Stress Scale (PSS), which is a 18-item psychometric scale (scored 1-5, where 1 indicates that the participant "Completely disagrees" with the statement and 5 indicates that the participant "Completely agrees" with the statement). Low scores indicate low levels of parental stress, whereas high scores indicate high levels of parental stress.
Another measure of stress is the Perceived Stress Scale 4 Items (PSS-4), which is a 4-item psychometric scale (scored 0-4, where 0 indicates "Never" and 4 indicates "Very often"). Low scores indicate low levels of stress, whereas high scores indicate high levels of stress.
The PSS measurement scale targets the specific kind of stress experienced by many parents, especially the stress experienced by parents of children with psychological/behavioral problems and children with disabilities. The PSS-4 measurement scale is designed to measure common stress symptoms.
Measured: Participants are assessed at the time of inclusion, circa two weeks prior to the beginning of the intervention (T1), post-treatment, at the time of completing the intervention (T2), and at around three months after completing the intervention (T3)
Study 2: Changes in depression and anxiety symptoms
The Hospital Anxiety and Depression Scale (HADS) consists of 14 items (scored 0-4, where 0 - "Often", and 4 - "Never"), subsequently summarized for an overall score. Low scores indicate none or very mild depressive and/or anxiety symptoms, whereas high scores indicate clinical levels of severe depression and or/anxiety.
Measured: Participants are assessed at the time of inclusion, circa two weeks prior to the beginning of the intervention (T1), post-treatment, at the time of completing the intervention (T2), and at around three months after completing the intervention (T3)
Study 2: Changes in mindfulness-based skills
The Mindfulness Awareness Attention Scale (MAAS), a 15-item scale (scored 1-6, where 1 indicates "Almost always" and 7 indicates "Never") assessing dispositional mindfulness in regards to cognitive, emotional, physical, interpersonal and general domains.
Measured: Participants are assessed at the time of inclusion, circa two weeks prior to the beginning of the intervention (T1), post-treatment, at the time of completing the intervention (T2), and at around three months after completing the intervention (T3)
Study 2: Changes in psychological flexibility and experiential acceptance
The AAQ assessment is intended to measure psychological flexibility and experiential acceptance in a general context. It intends to measure to which extent one accepts inner experiences, and the readiness to take appropriate and needed action in one's life (commitment to values-based actions). AAQ is a 7-item psychometric scale (scored 1-7, where 1 indicates "Never true" and 7 indicates "Always true").
Measured: Participants are assessed at the time of inclusion, circa two weeks prior to the beginning of the intervention (T1), post-treatment, at the time of completing the intervention (T2), and at around three months after completing the intervention (T3)
Study 2: Change in child's difficulties and the impact of these difficulties on the child's family
The Strengths and Difficulties Questionnaire (P4-17 SDQ), a caregiver administered, 25-item extended version of SDQ used for behavior screening of children and adolescents in ages 4-17 years. The SDQ P4-17 covers common areas of emotional and behavioral difficulties and strengths. It also includes a caregiver reported impact and burden assessment.
Measured: Participants are assessed at the time of inclusion, circa two weeks prior to the beginning of the intervention (T1), post-treatment, at the time of completing the intervention (T2), and at around three months after completing the intervention (T3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2023
- Study start1 Feb 2021
- Primary completion30 Nov 2023 (estimated)
- Study completion30 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ParentsStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The main study in this project (Study 2) is a randomized controlled trial in which the participants are randomly assigned either a group intervention (Navigator ACT), or an internet-delivered ACT intervention (I-Navigator ACT). No treatment-as-usual (TAU) or wait-list control groups are included in this model.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Region Stockholm, Forte, Stiftelsen Frimurarna Barnhuset
- Responsible party
- Principal investigator, Tatja Hirvikoski, Karolinska Institutet
- Investigators
- Tatja Hirvikoski, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05940168
- Sponsor's protocol ID
- I-Navigator ACT
- Status last verified
- Jul 2023
- First submitted
- 3 Jul 2023
- Last updated
- 11 Jul 2023
- Results posted
- No
- Data monitoring committee
- 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 11 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility, Effectiveness and Qualitative Experiences of Internet-delivered ACT for Parents of Children With Disabilities
- ClinicalTrials.gov ID
- NCT05940168
- Acronym / sponsor ID
- I-Navigator ACT
- Conditions
- Parents, Stress, Psychological, Anxiety, Depression, Neurodevelopmental Disorders, Autism Spectrum Disorder
- Keywords
- Acceptance and Commitment Therapy, Mindfulness, Experiential avoidance, Autistic children, Parental stress, Disability, Mental health, Telehealth
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Region Stockholm, Forte, Stiftelsen Frimurarna Barnhuset
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 30 Nov 2023 (estimated)
- Study completion
- 30 Nov 2023 (estimated)
- First posted
- 11 Jul 2023 (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.
The purpose of the project is to evaluate the feasibility, acceptability, and effectiveness of the internet-delivered Acceptance and Commitment Therapy treatment (I-Navigator ACT) for parents who experience stress, distress, depression or anxiety that may be associated with being a parent of a child with disabilities. The project consists of three studies:
Study 1: An open feasibility trial in which parents participate in an individual, clinician-supported internet-delivered Acceptance and Commitment Therapy treatment.
Study 2: A randomized controlled trial in which participants are randomly assigned either:
- Navigator ACT group treatment, where parents participate in an Acceptance and Commitment Therapy group together with other parents, led by two group leaders, or
- I-Navigator ACT internet-delivered Acceptance and Commitment Therapy treatment, where the parent participates on their own, coached by a clinician via a message function.
Study 3: A qualitative study in which a smaller sample of parents from the open feasibility trial participate in semi-structured interviews. The interviews take place after the parents have completed I-Navigator ACT.
All three studies are conducted in a clinical health care context.
Detailed description
Internet Navigator ACT (I-Navigator ACT) is an individual, internet-delivered Acceptance and Commitment Therapy (ACT) treatment, adapted from the manualized ACT group Navigator ACT for parents of children with disabilities. The purpose of I-Navigator ACT is to provide a treatment option that isn't bound by geography, especially beneficial for patients who have limited access to in-person support and care. I-Navigator ACT was developed with a co-creation approach, which included pilot testing with a small group of parents to gather their detailed feedback. Their feedback was considered for refining the treatment.
I-Navigator ACT consists of ten online modules with different themes based on ACT processes. Participants receive weekly written support from an experienced clinician (coach), via a message function. The program is available through the Swedish national platform for internet-delivered treatments (1177.se).
There are three studies planned in this project. The first study (Study 1) will be conducted as a open feasibility trial, in which all participating parents after enrolment and inclusion (via telephone or video call) will be allocated to the I-Navigator ACT treatment. The main purpose of this study is to evaluate feasibility and acceptability of the treatment. Feasibility is measured through treatment completion, treatment credibility and expectation, as well as treatment satisfaction. Preliminary outcomes regarding effectiveness will also be evaluated in this study. Participants are being assessed at pre-treatment, post-treatment, and three months post-treatment.
The second study (Study 2) will be conducted as a randomized controlled trial with two treatment arms. The randomized controlled trial is conducted to evaluate the effectiveness of the I-Navigator ACT treatment compared to the Navigator ACT group treatment. After enrolment and screening via telephone or video call, eligible participants are invited to an information meeting. Once the participants have given their informed consent and completed pre-treatment assessments, they are randomly assigned either the five-session Navigator ACT group, or the I-Navigator ACT treatment. The treatments run parallel during the same semester, and participants are being assessed at the same time points (pre-treatment, post-treatment, and three months post treatment). Effectiveness will be evaluated through the primary outcome measure of acceptance and action-based skills, and secondary outcome measures parental stress, depression and anxiety symptoms, experiential avoidance, mindfulness-based skills, and parent-rated child behavioral problems.
The third and final study (Study 3) will be a qualitative study based on semi-structured interviews, and will be utilizing a thematic content analysis. The interviews will mainly focus on the experience of participating in an internet-delivered ACT treatment for parents.
Data collection commenced in early spring of 2021 (beginning with the open feasibility study) and is projected to be completed by November 2023. N = 32 participants have been allocated to treatment in the open feasibility study, whereas n = 134 participants have been allocated to treatment in the RCT. Nine parents have participated in qualitative interviews.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- The main study in this project (Study 2) is a randomized controlled trial in which the participants are randomly assigned either a group intervention (Navigator ACT), or an internet-delivered ACT intervention (I-Navigator ACT). No treatment-as-usual (TAU) or wait-list control groups are included in this model.
| Arm | Type | Receives |
|---|---|---|
| Navigator ACT group | Active comparator | Behavioral: Navigator ACT groupThis is a manualized Acceptance and Commitment Therapy group-intervention for 8-16 parents of children with disabilities. The intervention consists of five group sessions with different themes, as well as a booster-session at three months after the fifth session. The intervention is held by two group leaders. |
| I-Navigator ACT | Experimental | Behavioral: I-Navigator ACTThis intervention is an internet-delivered version of the manualized Acceptance and Commitment Therapy group. The internet-delivered version is given as an individual treatment via a secure online treatment platform. It consists of ten separate chapters or modules. The duration of the intervention is 10-12 weeks, with a individual follow up-session by phone or video at three months after completion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Being a parent of at least one child (4-17 years of age) with any or several of the following disabilities: autism spectrum disorder, attention deficit hyperactivity disorder, intellectual disability, physical disability (eg cerebral palsy), traumatic brain injury and/or a profund and multiple intellectual disability (PMID)
- Experiencing stress, distress, depression and/or anxiety that to some extent may be associated with being a parent of a child with a disability
- Having access to a personal computer or tablet with a stable internet connection
- In Study 2 (RCT) also: being able to participate in the group treatment OR the internet-delivered treatment
Key exclusion criteria (6 listed)
- Currently experiencing a serious mental disorder (eg ongoing psychosis, acute suicidal behaviours) or currently being treated at an in-patient mental health facility
- Not experiencing stress, distress, depression and/or anxiety that to some extent may be associated with being a parent of a child with a disability
- Not being able to read, write or speak the Swedish language
- Not being able to participate in all planned sessions
- Not having access to a personal computer or tablet with a stable internet connection
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 |
|---|---|---|
| I-Navigator ACTThe intervention is an internet-delivered ten module Acceptance and Commitment Therapy treatment program for stressed and distressed parents of children with disabilities. The contents of the program is mostly text based, but also includes videos, mindfulness exercises and written exercises, as well as homework between modules. | Behavioural | I-Navigator ACT |
| Navigator ACT groupThe intervention is a five session Acceptance and Commitment Therapy group treatment for stressed and distressed parents of children with disabilities. All five sessions have different themes and are held by two group leaders. Sessions are around two and a half hours long. Homework is given between sessions. | Behavioural | Navigator ACT group |
Primary outcome
Study 1: Treatment completion rate
Time frame: Participants are assessed during the 10-12 weeks long treatment.
In this feasibility study (study 1), treatment completion is defined as completing 7 out of 10 intervention sessions/modules. The benchmark for good feasibility is 75% of participants completing the treatment.
Study 2: Changes in parental psychological flexibility and experiential acceptance
Time frame: Participants are assessed at the time of inclusion, circa two weeks prior to the beginning of the intervention (T1), post-treatment, at the time of completing the intervention (T2), and at around three months after completing the intervention (T3)
Parental Acceptance and Action Questionnaire (PAAQ), a scale that targets psychological flexibility and experiential acceptance in the parenting context, i.e., measures to which extent parents' accept inner experiences related to parenting and the readiness to take appropriate and needed action in parenting (commitment to values-based actions). This was originally a 19-item scale.
Study 3: Experiences of participating in an internet-delivered ACT treatment for parents
Time frame: The interviews are conducted after (circa 3 months) parents have participated in the I-Navigator ACT treatment.
The semi-structured interviews with parents after they have participated in the I-Navigator ACT treatment are based on the following seven interview questions: 1. How was your experience participating in I-Navigator ACT? 2. What aspects of the treatment did you appreciate? 3. What aspects of the treatment did you appreciate less? 4. Have you noticed any changes in your life, or everyday life after going through the treatment? Could you describe them? 5. What aspects of the treatment do you think will be useful to you? 6. What would you like to change about the treatment? 7. If you were given the possibility to participate in the treatment but in a different format, eg in a group context, or one-on-one with your care provider in a physical room, what do you think would have been different, and what would be quite similar to your experience? How do you think you would find that?
10 secondary outcomes
Study 1: Changes in general stress and parental stress
Time frame: Participants are assessed at the time of inclusion, circa two weeks prior to the beginning of the intervention (T1), post-treatment, at the time of completing the intervention (T2), and at around three months after completing the intervention (T3)
Study 1: Changes in depression and anxiety symptoms
Time frame: Participants are assessed at the time of inclusion, circa two weeks prior to the beginning of the intervention (T1), post-treatment, at the time of completing the intervention (T2), and at around three months after completing the intervention (T3)
Study 1: Changes in mindfulness-based skills
Time frame: Participants are assessed at the time of inclusion, circa two weeks prior to the beginning of the intervention (T1), post-treatment, at the time of completing the intervention (T2), and at around three months after completing the intervention (T3)
Study 1: Changes in psychological flexibility and experiential acceptance
Time frame: Participants are assessed at the time of inclusion, circa two weeks prior to the beginning of the intervention (T1), post-treatment, at the time of completing the intervention (T2), and at around three months after completing the intervention (T3)
Study 1: Change in child's difficulties and the impact of these difficulties on the child's family
Time frame: Participants are assessed at the time of inclusion, circa two weeks prior to the beginning of the intervention (T1), post-treatment, at the time of completing the intervention (T2), and at around three months after completing the intervention (T3)
Study 2: Changes in general stress and parental stress
Time frame: Participants are assessed at the time of inclusion, circa two weeks prior to the beginning of the intervention (T1), post-treatment, at the time of completing the intervention (T2), and at around three months after completing the intervention (T3)
Study 2: Changes in depression and anxiety symptoms
Time frame: Participants are assessed at the time of inclusion, circa two weeks prior to the beginning of the intervention (T1), post-treatment, at the time of completing the intervention (T2), and at around three months after completing the intervention (T3)
Study 2: Changes in mindfulness-based skills
Time frame: Participants are assessed at the time of inclusion, circa two weeks prior to the beginning of the intervention (T1), post-treatment, at the time of completing the intervention (T2), and at around three months after completing the intervention (T3)
Study 2: Changes in psychological flexibility and experiential acceptance
Time frame: Participants are assessed at the time of inclusion, circa two weeks prior to the beginning of the intervention (T1), post-treatment, at the time of completing the intervention (T2), and at around three months after completing the intervention (T3)
Study 2: Change in child's difficulties and the impact of these difficulties on the child's family
Time frame: Participants are assessed at the time of inclusion, circa two weeks prior to the beginning of the intervention (T1), post-treatment, at the time of completing the intervention (T2), and at around three months after completing the intervention (T3)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2023.
- Individual participant dataSharing planned: No
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The Decision To Enroll In Therapeutic Clinical Trials In A Pediatric Cancer Clinical Network
Knowledge, Attitudes, Practice
RecruitingObservational study
Psychotherapy for Irritability in Youth: Comparing Active Treatment to Nonactive Psychoeducation Supportive Psychotherapy
Irritability, Disruptive Mood Dysregulation Disorder
Not yet recruiting
Effectiveness of a 10-week Multicomponent Intervention Combined With Parent Education on Binge Eating Behavior in Children and Adolescents
Binge Eating Disorder, Binge Eating
Not yet recruiting
"Family Resilience And Mind-body Enhancement" (FRAME): A Randomised Controlled Trial
Autism
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.
Tatja Hirvikoski, PhD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing I-Navigator ACT and Navigator ACT group in people with Parents and Stress, Psychological, run by Karolinska Institutet at 1 site in Sweden.
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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 11 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
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?
Study 1: Treatment completion rate (time frame: Participants are assessed during the 10-12 weeks long treatment.). The study lists 3 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 11 Jul 2023.