Navigator ACT Group Intervention for Parents of Children with Disabilities

NCT03830476 | Completed

• 1 other identifier: Navigator ACT
• Study Type: interventional
• Target: 137
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

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

Keywords

Acceptance- and Commitment Therapy, ACT, parenting stress, parenting a child with disability, depression, anxiety, disabilities

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 2. Change (increase) in mindfulness skills

  [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: 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: 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: Change in psychological flexibility measured at baseline, immediately after the intervention and at three-four month follow-up]

Other Outcomes (3)

• Treatment Credibility Scale (TCS)

  Measured at baseline,and immediately after the intervention.

• Session Evaluation Form (SEF)

  Up to 3 months

• Patient Evaluation Form (PEF)

  Up to 3 months

Study Arms (2)

Acceptance- and Commitment therapy group

EXPERIMENTAL

Experiment group that receives the treatment direct after the baseline measurement.

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.

Behavioral: Treatment as usual.

Interventions

Acceptance- and Commitment therapy group for parents to children with disabilities BEHAVIORAL

ACT groups adjusted for parents of children with (any kind of) disabilities.

Also known as: Navigator ACT group treatment

Acceptance- and Commitment therapy group

Treatment as usual. BEHAVIORAL

Treatment as usual within outpatient disability services.

Treatment as usual

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Parent report their own and their child's sex/gender during the screening interview.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• deep depression with suicidality
• psychosis or manic episodes
• severe post-traumatic stress disorder (PTSD)
• homelessness or other extreme life situation

Sponsors & Collaborators

• Karolinska Institutet: lead
• Region Stockholm: collaborator

Study Sites (1)

Tiina Maria Holmberg Bergman

Knivsta, 74131, Sweden

Location

Related Links

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

MeSH Terms

Conditions

Developmental Disabilities; Child Behavior; Depression; Anxiety Disorders

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Neurodevelopmental Disorders; Mental Disorders; Behavior; Behavioral Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: Masking at baseline of both participant and care-provider.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Feasibility study and Randomised Controlled Trial

Study Record Dates

• First Submitted: February 2, 2019
• First Posted: February 5, 2019
• Study Start: January 2, 2016
• Primary Completion: October 31, 2021
• Study Completion: October 31, 2021
• Last Updated: September 23, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)