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Navigator ACT Group Intervention for Parents to Children With Disabilities (NavigatorACT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03830476
Recruitment Status : Completed
First Posted : February 5, 2019
Last Update Posted : March 9, 2022
Sponsor:
Collaborator:
Region Stockholm
Information provided by (Responsible Party):
Tatja Hirvikoski, Karolinska Institutet

Tracking Information
First Submitted Date  ICMJE February 2, 2019
First Posted Date  ICMJE February 5, 2019
Last Update Posted Date March 9, 2022
Actual Study Start Date  ICMJE January 2, 2016
Actual Primary Completion Date October 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 2, 2019)
1. Change (increase) in parental psychological flexibility [ 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 15-item scale that targets psychological flexibility in the parenting context, i.e. measures to which extent parents' accept inner and outer experiences as they are and are willing to take action in parenting situations
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 2, 2019)
  • 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] ]
    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.
  • 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] ]
    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.
  • 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] ]
    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.
  • 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] ]
    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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: February 2, 2019)
Treatment Credibility Scale (TCS) [ Time Frame: Time Frame: Measured at baseline, immediately after the intervention and at three month follow-up] ]
As a measure of feasibility, TCS is used to measure the expectation of improvement and treatment credibility. The TCS is a visual analogue scale rated from "Low credibility"/ "Not at all" (0) to "High credibility"/"Very much" (10) and the score calculated is a mean of all items. The TCS was administered after providing thorough information and presentation of the treatment content at baseline and after completion of the treatment. The item wording after adjustment to the current study were: (1) How logical does Navigator ACT treatment seem to you? (2) How confident are you that this treatment will reduce your distress? (3) Would you recommend Navigator ACT to a friend experiencing the same type of distress? (4) How successful do you feel this type of intervention is in improving your psychological health? 5) At this very moment, to what degree the intervention has improved your psychological health?
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Navigator ACT Group Intervention for Parents to Children With Disabilities
Official Title  ICMJE Navigator ACT-Acceptance and Commitment Therapy-group Treatment for Distressed and Stressed Parents to Children With Disabilities
Brief Summary The main purpose of the pragmatic multicenter studies is to investigate acceptance and commitment (ACT) therapy groups in treatment of distress in parents to children with disabilities, as well as to investigate the concept of psychological flexibility in the context of parenting. The first phase includes a feasibility study (n=94) of Navigator ACT for parents to children with disabilties (participating in the Navigator ACT group treatment for symptoms of stress, depression and anxiety). In the second phase a randomised controlled trial (RCT) is conducted (expected n=approximately 100 parents to children with disabilties). The participants are parents tochild/children 0-17 years and currently living in Sweden.
Detailed Description

Navigator ACT group treatment is manual-based, transdiagnostic, novel intervention developed in Habilitation and Health diability services in Stockholm. The treatment consists of 5 sessions (each 3.5 hours), and is developed to address distress in parents raising a child with disabilities.The aims of the study is to examine the feasibility, social validity, participant satisfaction, credibility and efficacy of the manual-based Navigator ACT group treatment in (a) improving psychological/behavioral flexibility (b) increasing mindfulness (c) reducing symptoms of depression and anxiety (d) reducing parenting stress (e) reducing 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. The pragmatic multicenter RCT will be conducted mainly in the regions of Stockholm and Västmanland disability services. 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 control group approximately six months after. The parents in the control group fill the efficacy-related self-rating forms at the same measuring points as the parents in the experiment group as well during their own group process.

The Regional Ethics Committee of Stockholm (2016/526-21-1,2016/115-31/4, 2017/573-31/5 ) has approved the studIes

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Feasibility study and Randomised Controlled Trail
Masking: Single (Care Provider)
Masking Description:
Masking at baseline of both participant and care-provider.
Primary Purpose: Treatment
Condition  ICMJE
  • Parenting
  • Stress
  • Disability, Developmental
  • Behavior, Child
  • Acceptance and Action Processes
  • Parent-Child Relations
  • Experiential Avoidance
Intervention  ICMJE
  • Behavioral: Acceptance- and Commitment therapy group for parents to children with disabilities
    ACT groups adjusted for parents to children with (any kind of) disabilities.
    Other Name: Navigator ACT group treatment
  • Behavioral: Treatment as usual.
    Treatment as usual within outpatient disability services.
Study Arms  ICMJE
  • Experimental: Acceptance- and Commitment therapy group
    Experiment group that receives the treatment direct after the baseline measurement.
    Intervention: Behavioral: Acceptance- and Commitment therapy group for parents to children with disabilities
  • Active Comparator: Treatment as usual
    Comparison group that receives treatment as usual and the Navigator ACT intervention appr 6 months later.
    Intervention: Behavioral: Treatment as usual.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 21, 2022)
670
Original Estimated Enrollment  ICMJE
 (submitted: February 2, 2019)
100
Actual Study Completion Date  ICMJE October 31, 2021
Actual Primary Completion Date October 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • a parent to a child 2-17 years with 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

Exclusion Criteria:

  • deep depression with suicidality
  • psychosis or manic episodes
  • severe post-traumatic stress disorder (PTSD)
  • homelessness or other extreme life situation
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Gender Based Eligibility: Yes
Gender Eligibility Description: Parent report their own and their child's gender during the screening interview.
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03830476
Other Study ID Numbers  ICMJE Navigator ACT
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Tatja Hirvikoski, Karolinska Institutet
Original Responsible Party Tatja Hirvikoski, Karolinska Institutet, Associate Professor, Docent
Current Study Sponsor  ICMJE Karolinska Institutet
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Region Stockholm
Investigators  ICMJE Not Provided
PRS Account Karolinska Institutet
Verification Date February 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP