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ACT -Groups for Parents to Children With Disabilities (NavigatorACT)

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ClinicalTrials.gov Identifier: NCT03830476
Recruitment Status : Recruiting
First Posted : February 5, 2019
Last Update Posted : February 5, 2019
Sponsor:
Collaborator:
Stockholm County Council, Sweden
Information provided by (Responsible Party):
Tatja Hirvikoski, Karolinska Institutet

Brief Summary:
The main purpose of the pragmatic multicenter RCT is to investigate acceptance and commitment therapy groups in treatment of distress in parents to children with disabilities.in a clinical disability services context. Participants in the study are parents reporting symptoms of depression, anxiety or parenting stress due to parenting a child with disability. The participants have a child/children (0-17 years) currently enrolled in the disability services in Sweden.

Condition or disease Intervention/treatment Phase
Parenting Stress Disability, Developmental Behavior, Child Acceptance Processes Parent-Child Relations Behavioral: Acceptance- and Commitment therapy group for parents to children with disabilities Behavioral: Treatment as usual. Not Applicable

Detailed Description:

Navigator ACT group treatment consists of 5 sessions (each 3.5 hours), and is developed to address distress in parents raising a child with an Autism Spectrum Disorder and/or other disabilities.The aims of the study is to examine the feasibility, participant satisfaction 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. This pragmatic multicenter RCT will be conducted mainly in Stockholm County Council disability services but even in other regions in 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 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 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 satisfaction is measured by session- and course evaluations. Five self-rating questionnaire 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.

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


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: RCT
Masking: Double (Participant, Care Provider)
Masking Description: Masking at baseline of both participant and care-provider.
Primary Purpose: Treatment
Official Title: Acceptance and Commitment Therapy Group, Navigator ACT for Parents to Children With Disabilities
Actual Study Start Date : January 2, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety Parenting

Arm Intervention/treatment
Experimental: Acceptance- and Commitment therapy group
Experiment group that receives the treatment direct after the baseline measurement.
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

Active Comparator: Treatment as usual
Comparison group that receives treatment as usual and the Navigator ACT intervention appr 6 months later.
Behavioral: Treatment as usual.
Treatment as usual within outpatient disability services.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.


Other Outcome Measures:
  1. 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?



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03830476


Contacts
Contact: Tatja Hirvikoski, Associate professor +46708327637 tatja.hirvikoski@ki.se
Contact: Tiina Holmberg Bergman, M.Sc. +46705755788 tiina.holmberg.bergman@ki.se

Locations
Sweden
Karolinska Institute Recruiting
Stockholm, Sweden, 17177
Contact: Tiina Holmberg Bergman    705755788    tiina.holmberg.bergman@ki.se   
Principal Investigator: Tatja Hirvikoski, Docent         
Sponsors and Collaborators
Karolinska Institutet
Stockholm County Council, Sweden

Responsible Party: Tatja Hirvikoski, Associate Professor, Docent, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT03830476     History of Changes
Other Study ID Numbers: THirvikoski
First Posted: February 5, 2019    Key Record Dates
Last Update Posted: February 5, 2019
Last Verified: February 2019

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Tatja Hirvikoski, Karolinska Institutet:
Acceptance- and Commitment Therapy, Parenting stress, depression, anxiety, parenting, children with disabilities

Additional relevant MeSH terms:
Developmental Disabilities
Neurodevelopmental Disorders
Mental Disorders