ParentingNavigatorACTNCT03830476
Navigator ACT Group Intervention for Parents of Children with Disabilities
A study testing Acceptance- and Commitment therapy group for parents to children with disabilities and Treatment as usual. in people with Parenting and Stress, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
The main purpose of the pragmatic multicenter studies is to investigate the trransdiagnostic, manualized Acceptance and Commitment Therapy (ACT) based group treatment (Navigator ACT) for treatment of stress and distress in parents of children with disabilities, and to investigate the concept of parental psychological… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parenting, Stress, Disability, Developmental
- What is being tested?
- Acceptance- and Commitment therapy group for parents to children with disabilities and Treatment as usual.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 137 participants
- Where
- 1 siteSweden
- Study dates
- 2 Jan 2016to 31 Oct 2021
- 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
- a parent to a child 0-18 years with diagnosed disability
- mild to severe symptoms of parental stress, depression or anxiety
- a possibility to participate in all group sessions
- an ability to function in a group
- a knowledge of the Swedish language
Who cannot join
- deep depression with suicidality
- psychosis or manic episodes
- severe post-traumatic stress disorder (PTSD)
- homelessness or other extreme life situation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Navigator ACT-Acceptance and Commitment Therapy-group Treatment for Distressed and Stressed Parents of Children with Disabilities
The main purpose of the pragmatic multicenter studies is to investigate the trransdiagnostic, manualized Acceptance and Commitment Therapy (ACT) based group treatment (Navigator ACT) for treatment of stress and distress in parents of children with disabilities, and to investigate the concept of parental psychological flexibility. The first phase includes a feasibility study (n=94) of the Navigator ACT for parents of children (0-17 years) with disabilties who participate in the Navigator ACT group treatment after being screened for symptoms of stress, depression and anxiety associated with the challenges of parenting. In the second phase (if treatment proves feasible), a randomised controlled trial (RCT) is conducted. In the RCT, approximately n=100 parents of children with disabilties were expected to be included, divided into experiment- and control groups. The recruitment takes places in several regions in Sweden. In addition, a psychometric evaluation of the main outcome instrument used in these studies, is going to be conducted. The Parental Acceptance and Action Questionnaire (PAAQ). In an additional study (expected n= ca 600), will focus on factors that explain treatment outcome and attrition.
Read the detailed description
Navigator ACT group treatment is a novel, manual-based, transdiagnostic group treatment developed in Habilitation and Health, the disability services in the region Stockholm, in Sweden. The treatment consists of 5 sessions (each 3.5 hours), and has a main aim of increasing psychological flexibility of stressed and distressed parents raising a child with disability. The studies included in this project examine the feasibility and effectiveness of the manual-based Navigator ACT group treatment in the Swedish habilitation services context. The guestions we ask are; Is the Navigator ACT a feasible treatment in the disability services context? Is it effective in (a) improving parental psychological flexibility (b) increasing mindfulness (c) reducing symptoms of depression and anxiety (d) reducing parenting stress (e) reducing parent-reported difficulties ior increasing prosocial behaviors(e.g., behavioral problems) of children with disability.
FAS 1: The feasibility study is conducted in 7 disability service clinics in Stockholm and Uppsala, Sweden.The feasibility of Navigator ACT in the disability services context is measured by attendance, that is: parents participating in at least 4 out of 5 sessions are considered as completers. The parent and treatment provider satisfaction is measured by session- and course evaluations. Both parents and group leaders treatment credibility and expectancy is measured as well. Five self-rating questionnaires are used to measure efficacy: The Mindfulness Awareness Attention Scale (MAAS), Parental Acceptance and Action Questionnaire (PAAQ) Parental Stress Scale (PSS) Hospital Anxiety and depression scale (HADS), The Strengths and Difficulties Questionnaire (SDQ). Self-rating questionnaires are administered to parents at the baseline (0-2 weeks before the treatment start, T1), at the end of the treatment (0-2 weeks after, T2) and at the follow-up (3-4 months after the end of the treatment, T3). The data will be analyzed from baseline T1 to T2 (post treatment) as well as from T1 (baseline) to T3 (follow-up) with separate series of repeated measures ANOVA between-group.
FAS 2: Psychometric evaluation of the Parental Acceptance and Action Questionnaire (PAAQ).
FAS 2. The pragmatic multicenter RCT will be conducted in at least four regions of Sweden. Parents participating in the study have their children (0-17 years) currently enrolled in the disability services (experiment group n=42, control group n=42, totaling at least 84 parents, with the power calculation for medium large effect of 90% ES=0.50). To balance for attrition approximately 100 parents will be included in the study. The participants will be block randomized in several blocks. The experiment group will be receiving Navigator ACT treatment directly after the randomizing procedure, the Treatment-As-Usual (TAU) control group approximately six months after. The parents in the TAU group fill the effectiveness-related self-rating forms at the same measuring points as the parents in the experiment group as well during their own group process. The differences between the experiment and control groups will be analyzed by mixed-model linear regression.
FAS4: The aim of this study is reveal which parents get the most benefit of the Navigator ACT treatment, and what factors predict treatment competition vs. attrition.
The Regional Ethics Committee of Stockholm (2016/526-21-1,2016/115-31/4, 2017/573-31/5 ) has approved the studIes.
- Conditions
- Parenting, Stress, Disability, Developmental, Behavior, Child, Acceptance and Action Processes, Parent-Child Relations
- Being tested
- Acceptance- and Commitment therapy group for parents to children with disabilities, Treatment as usual.
- Keywords
- Acceptance- and Commitment Therapy, ACT, parenting stress, parenting a child with disability, depression, anxiety, disabilities
- Medical subject headings
- Developmental Disabilities, Child Behavior, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance- and Commitment therapy group for parents to children with disabilitiesBehavioural
Also called Navigator ACT group treatment
ACT groups adjusted for parents of children with (any kind of) disabilities.
Treatment as usual.Behavioural
Treatment as usual within outpatient disability services.
| Study group | Role | What they receive |
|---|---|---|
| Acceptance- and Commitment therapy group | Experimental | Experiment group that receives the treatment direct after the baseline measurement. Receives: Behavioral: Acceptance- and Commitment therapy group for parents to children with disabilities |
| Treatment as usual | Active comparator | Comparison group that receives treatment as usual and the Navigator ACT intervention appr 6 months later. Receives: Behavioral: Treatment as usual. |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. Change (increase) 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/needed action in parenting (commitment to values-based actions). Originally 19-item scale.
Measured: [Time Frame: Change in psychological flexibility measured at baseline, immediately after the intervention and at three-four month follow-up]
Secondary outcomes (4)
2. Change (increase) in mindfulness skills
The Mindfulness Awareness Attention Scale (MAAS), a 15-item scale (scored 1-6) assessing dispositional mindfulness in regards to cognitive, emotional, physical, interpersonal and general domains.
Measured: [Time Frame: Change in psychological flexibility measured at baseline, immediately after the intervention and at three-four month follow-up]
3. Change (decrease) in depression and anxiety
Hospital Anxiety and Depression Scale (HADS). Has 14 items scored 0 ("Often") - 3 ("Seldom"), subsequently summarized for an overall score; high scores indicate higher levels of depression or anxiety.
Measured: [Time Frame: Change in psychological flexibility measured at baseline, immediately after the intervention and at three-four month follow-up]
4. Change (decrease) in parental stress.
The Parental Stress Scale (PSS) is a18-item tool for measurement of parenting stress, scored 1-5 on a 5-point Likert scale. The initial factor has suggested four-factor structure for the PSS consisting of parental 1) rewards, 2) stressors, 3) lack of control and 4) satisfaction in parenting. High scores indicate higher levels of stress in parenting context.
Measured: [Time Frame: Change in psychological flexibility measured at baseline, immediately after the intervention and at three-four month follow-up]
5. Change (decrease) 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 as well as includes a caregiver reported impact- and burden assessment.
Measured: [Time Frame: Change in psychological flexibility measured at baseline, immediately after the intervention and at three-four month follow-up]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2019
- Study start2 Jan 2016
- Primary completion31 Oct 2021
- Study completion31 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ParentingStudies 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
- Feasibility study and Randomised Controlled Trial
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Region Stockholm
- Responsible party
- Principal investigator, Tatja Hirvikoski, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03830476
- Sponsor's protocol ID
- Navigator ACT
- Acronym
- NavigatorACT
- Status last verified
- Sep 2024
- First submitted
- 2 Feb 2019
- Last updated
- 23 Sep 2024
- 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 23 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Navigator ACT-Acceptance and Commitment Therapy-group Treatment for Distressed and Stressed Parents of Children with Disabilities
- ClinicalTrials.gov ID
- NCT03830476
- Acronym / sponsor ID
- NavigatorACT / Navigator ACT
- Conditions
- Parenting, Stress, Disability, Developmental, Behavior, Child, Acceptance and Action Processes, Parent-Child Relations
- Keywords
- Acceptance- and Commitment Therapy, ACT, parenting stress, parenting a child with disability, depression, anxiety, disabilities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Region Stockholm
- Study start
- 2 Jan 2016 (actual)
- Primary completion
- 31 Oct 2021 (actual)
- Study completion
- 31 Oct 2021 (actual)
- First posted
- 5 Feb 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.
The main purpose of the pragmatic multicenter studies is to investigate the trransdiagnostic, manualized Acceptance and Commitment Therapy (ACT) based group treatment (Navigator ACT) for treatment of stress and distress in parents of children with disabilities, and to investigate the concept of parental psychological flexibility. The first phase includes a feasibility study (n=94) of the Navigator ACT for parents of children (0-17 years) with disabilties who participate in the Navigator ACT group treatment after being screened for symptoms of stress, depression and anxiety associated with the challenges of parenting. In the second phase (if treatment proves feasible), a randomised controlled trial (RCT) is conducted. In the RCT, approximately n=100 parents of children with disabilties were expected to be included, divided into experiment- and control groups. The recruitment takes places in several regions in Sweden. In addition, a psychometric evaluation of the main outcome instrument used in these studies, is going to be conducted. The Parental Acceptance and Action Questionnaire (PAAQ). In an additional study (expected n= ca 600), will focus on factors that explain treatment outcome and attrition.
Detailed description
Navigator ACT group treatment is a novel, manual-based, transdiagnostic group treatment developed in Habilitation and Health, the disability services in the region Stockholm, in Sweden. The treatment consists of 5 sessions (each 3.5 hours), and has a main aim of increasing psychological flexibility of stressed and distressed parents raising a child with disability. The studies included in this project examine the feasibility and effectiveness of the manual-based Navigator ACT group treatment in the Swedish habilitation services context. The guestions we ask are; Is the Navigator ACT a feasible treatment in the disability services context? Is it effective in (a) improving parental psychological flexibility (b) increasing mindfulness (c) reducing symptoms of depression and anxiety (d) reducing parenting stress (e) reducing parent-reported difficulties ior increasing prosocial behaviors(e.g., behavioral problems) of children with disability.
FAS 1: The feasibility study is conducted in 7 disability service clinics in Stockholm and Uppsala, Sweden.The feasibility of Navigator ACT in the disability services context is measured by attendance, that is: parents participating in at least 4 out of 5 sessions are considered as completers. The parent and treatment provider satisfaction is measured by session- and course evaluations. Both parents and group leaders treatment credibility and expectancy is measured as well. Five self-rating questionnaires are used to measure efficacy: The Mindfulness Awareness Attention Scale (MAAS), Parental Acceptance and Action Questionnaire (PAAQ) Parental Stress Scale (PSS) Hospital Anxiety and depression scale (HADS), The Strengths and Difficulties Questionnaire (SDQ). Self-rating questionnaires are administered to parents at the baseline (0-2 weeks before the treatment start, T1), at the end of the treatment (0-2 weeks after, T2) and at the follow-up (3-4 months after the end of the treatment, T3). The data will be analyzed from baseline T1 to T2 (post treatment) as well as from T1 (baseline) to T3 (follow-up) with separate series of repeated measures ANOVA between-group.
FAS 2: Psychometric evaluation of the Parental Acceptance and Action Questionnaire (PAAQ).
FAS 2. The pragmatic multicenter RCT will be conducted in at least four regions of Sweden. Parents participating in the study have their children (0-17 years) currently enrolled in the disability services (experiment group n=42, control group n=42, totaling at least 84 parents, with the power calculation for medium large effect of 90% ES=0.50). To balance for attrition approximately 100 parents will be included in the study. The participants will be block randomized in several blocks. The experiment group will be receiving Navigator ACT treatment directly after the randomizing procedure, the Treatment-As-Usual (TAU) control group approximately six months after. The parents in the TAU group fill the effectiveness-related self-rating forms at the same measuring points as the parents in the experiment group as well during their own group process. The differences between the experiment and control groups will be analyzed by mixed-model linear regression.
FAS4: The aim of this study is reveal which parents get the most benefit of the Navigator ACT treatment, and what factors predict treatment competition vs. attrition.
The Regional Ethics Committee of Stockholm (2016/526-21-1,2016/115-31/4, 2017/573-31/5 ) has approved the studIes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- Feasibility study and Randomised Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Acceptance- and Commitment therapy group | Experimental | Behavioral: Acceptance- and Commitment therapy group for parents to children with disabilitiesExperiment group that receives the treatment direct after the baseline measurement. |
| Treatment as usual | Active comparator | Behavioral: Treatment as usual.Comparison group that receives treatment as usual and the Navigator ACT intervention appr 6 months later. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- a parent to a child 0-18 years with diagnosed disability
- mild to severe symptoms of parental stress, depression or anxiety
- a possibility to participate in all group sessions
- an ability to function in a group
- a knowledge of the Swedish language
Key exclusion criteria (4 listed)
- deep depression with suicidality
- psychosis or manic episodes
- severe post-traumatic stress disorder (PTSD)
- homelessness or other extreme life situation
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 |
|---|---|---|
| Acceptance- and Commitment therapy group for parents to children with disabilitiesAlso: Navigator ACT group treatmentACT groups adjusted for parents of children with (any kind of) disabilities. | Behavioural | Acceptance- and Commitment therapy group |
| Treatment as usual.Treatment as usual within outpatient disability services. | Behavioural | Treatment as usual |
Primary outcome
1. Change (increase) in parental psychological flexibility and experiential acceptance
Time frame: [Time Frame: Change in psychological flexibility measured at baseline, immediately after the intervention and at three-four month follow-up]
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/needed action in parenting (commitment to values-based actions). Originally 19-item scale.
4 secondary outcomes
2. Change (increase) in mindfulness skills
Time frame: [Time Frame: Change in psychological flexibility measured at baseline, immediately after the intervention and at three-four month follow-up]
3. Change (decrease) in depression and anxiety
Time frame: [Time Frame: Change in psychological flexibility measured at baseline, immediately after the intervention and at three-four month follow-up]
4. Change (decrease) in parental stress.
Time frame: [Time Frame: Change in psychological flexibility measured at baseline, immediately after the intervention and at three-four month follow-up]
5. Change (decrease) in child's difficulties and the impact of these difficulties on the child's family.
Time frame: [Time Frame: Change in psychological flexibility measured at baseline, immediately after the intervention and at three-four month follow-up]
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 23 Sep 2024.
- Acceptance and Commitment Therapy Group Intervention for Parents of Children with Disabilities (Navigator ACT): An Open Feasibility TrialLink provided by the sponsor.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acceptance- and Commitment therapy group for parents to children with disabilities and Treatment as usual. in people with Parenting and Stress, 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 5 inclusion and 4 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 23 Sep 2024. 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?
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?
1. Change (increase) in parental psychological flexibility and experiential acceptance (time frame: [Time Frame: Change in psychological flexibility measured at baseline, immediately after the intervention and at three-four month follow-up]). 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 23 Sep 2024.