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

• ClinicalTrials.gov Identifier: NCT03830476
• Recruitment Status: Completed
• First Posted: February 5, 2019
• Last Update Posted: March 9, 2022
• Sponsor: Karolinska Institutet
• Collaborator: Region Stockholm
• Information provided by (Responsible Party): Tatja Hirvikoski, Karolinska Institutet

Tracking Information

• First Submitted Date: February 2, 2019
• First Posted Date: February 5, 2019
• Last Update Posted Date: March 9, 2022
• Actual Study Start Date: January 2, 2016
• Actual Primary Completion Date: October 31, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: 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: Navigator ACT Group Intervention for Parents to Children With Disabilities
• Official Title: 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: Interventional
• Study Phase: Not Applicable

Study Design

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

• Parenting
• Stress
• Disability, Developmental
• Behavior, Child
• Acceptance and Action Processes
• Parent-Child Relations
• Experiential Avoidance

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 21, 2022): 670
• Original Estimated Enrollment (submitted: February 2, 2019): 100
• Actual Study Completion Date: October 31, 2021
• Actual Primary Completion Date: October 31, 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• 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: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Sweden

Administrative Information

• NCT Number: NCT03830476
• Other Study ID Numbers: 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: Not Provided
• Current Responsible Party: Tatja Hirvikoski, Karolinska Institutet
• Original Responsible Party: Tatja Hirvikoski, Karolinska Institutet, Associate Professor, Docent
• Current Study Sponsor: Karolinska Institutet
• Original Study Sponsor: Same as current
• Collaborators: Region Stockholm
• Investigators: Not Provided
• PRS Account: Karolinska Institutet
• Verification Date: February 2022