Navigator ACT Group Intervention for Parents of Children With Disabilities

Stress Clinical Trial

— NavigatorACT  

Official title:

Navigator ACT-Acceptance and Commitment Therapy-group Treatment for Distressed and Stressed Parents of Children With Disabilities

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03830476
• Other study ID #: Navigator ACT
• Status: Completed
• Phase: N/A
• Start date: January 2, 2016
• Est. completion date: October 31, 2021

Study information

• Verified date: August 2023
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main purpose of the pragmatic multicenter studies is to investigate the trransdiagnostic, manualized acceptance and commitment (ACT) therapy group treatment (Navigator ACT) in treatment of stress and distress in parents of children with disabilities, and to investigate the concepts of experiential avoidance and psychological flexibility in the context of parenting. 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 a randomised controlled trial (RCT) is conducted. In the RCT, we expect to include approximately n=100 parents of children with disabilties divided into experiment- and control groups. The recruitment takes places in several regions in Sweden. In addition, we are going to complete a psychometric evaluation of the main outcome instrument used in these studies, The Parental Acceptance and Action Questionnaire (PAAQ). In an additional study (expected n= ca 600), we will predict factors that explain treatment outcome and attrition as well as investigate process variables in a mediation model,

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. The treatment consists of 5 sessions (each 3.5 hours), and is developed to address stress and distress in parents raising a child with disability. The aims of the several studies included in this project is to examine the feasibility and effectiveness/efficacy 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? Is it effective in (a) improving parental psychological flexibility/experiential acceptance (b) increasing mindfulness (c) reducing symptoms of depression and anxiety (d) reducing parenting stress (e) reducing parent-reported difficulties (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 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 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 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. An additional aim is to investigate what treatment specific ACT processes mediate the treatment outcomes.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 129
• Est. completion date: October 31, 2021
• Est. primary completion date: October 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• a parent to a child 0-17 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

Related Conditions & MeSH terms

• Behavior, Child
• Depression
• Depression, Anxiety
• Developmental Disabilities
• Disability, Developmental
• Parent-Child Relations
• Parenting
• Stress

Intervention

Behavioral:
• Acceptance- and Commitment therapy group for parents to children with disabilities
ACT groups adjusted for parents of children with (any kind of) disabilities.
• Treatment as usual.
Treatment as usual within outpatient disability services.

Locations

Country	Name	City	State
Sweden	Tiina Maria Holmberg Bergman	Knivsta

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	Region Stockholm

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Treatment Credibility Scale (TCS)	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?	Measured at baseline,and immediately after the intervention.
Other	Session Evaluation Form (SEF)	Measures treatment satisfaction regarding each treatment session	Up to 3 months
Other	Patient Evaluation Form (PEF)	Measures overall treatment satisfaction	Up to 3 months
Primary	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.	[Time Frame: Change in psychological flexibility measured at baseline, immediately after the intervention and at three-four month follow-up]
Secondary	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.	[Time Frame: Change in psychological flexibility measured at baseline, immediately after the intervention and at three-four month follow-up]
Secondary	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.	[Time Frame: Change in psychological flexibility measured at baseline, immediately after the intervention and at three-four month follow-up]
Secondary	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.	[Time Frame: Change in psychological flexibility measured at baseline, immediately after the intervention and at three-four month follow-up]
Secondary	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.	[Time Frame: Change in psychological flexibility measured at baseline, immediately after the intervention and at three-four month follow-up]

External Links

•   Acceptance and Commitment Therapy Group Intervention for Parents of Children with Disabilities (Navigator ACT): An Open Feasibility Trial