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Recruiting NCT07345806

A Pilot Study on an ACT-Based Program for Individuals With Special Needs and Their Caregivers

No phase Interventional Parenting Stress Psychological Flexibility

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Acceptance and Commitment Therapy.
Who it may be relevant to
Registry conditions: Parenting Stress, Psychological Flexibility. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Hong Kong
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Promoting Wellbeing and Personal Values: A Pilot Study on a Group-Based Program for Individuals With Special Needs and Their Caregivers

Overview

Parenting children with special health care needs can be stressful and weigh on the caregivers' mental health. For the individuals with special needs, the mismatch between their needs and the normative practice in the world around them can be frustrating and detrimental to their functioning. The demands and concerns to these families can be so real that it may not be sensible to examine the validity or helpfulness of the distressing thoughts or feelings but to promote psychological flexibility, which is a key to value-guided living. This pilot study explores the effects and feasibility of a group-based intervention for families of individuals with special health care needs.

Interventions

  • Behavioral Acceptance and Commitment Therapy
    Acceptance and Commitment Therapy (ACT) is a well-established and evidence-based psychotherapy for individuals at different ages and with different clinical needs. The protocol used in the current study is adapted from an established local group intervention and tailored to families of individuals with special health care needs.

Primary outcome measures

  • Change from Baseline in Psychological Flexibility as Measured by the Multidimensional Psychological Flexibility Inventory [Time frame: From baseline (T0) to two (T1), four (T2), and six (T3; post-intervention) weeks into treatment]
  • Change from Baseline in Psychological Inflexibility as Measured by the Multidimensional Psychological Flexibility Inventory [Time frame: From baseline (T0) to two (T1), four (T2), and six (T3; post-intervention) weeks into treatment]
  • Change from Baseline in Psychological Well-being as Measured by the 5-Item World Health Organization Well-being Index [Time frame: From baseline (T0) to two (T1), four (T2), and six (T3; post-intervention) weeks into treatment]
  • Change from Baseline in Parenting Stress as Measured by the Parenting Stress Scale [Time frame: From baseline to six weeks into treatment]
Secondary outcome measures (4)
  • Change from Baseline in Child Externalizing as Measured by the Strengths and Difficulties Questionnaire [Time frame: From baseline to six weeks into treatment (i.e., post-intervention)]
  • Change from Baseline in Child Internalizing as Measured by the Strengths and Difficulties Questionnaire [Time frame: From baseline to six weeks into treatment (i.e., post-intervention)]
  • Participants' Satisfaction with the Intervention Program [Time frame: Six-week into treatment (i.e., post-intervention)]
  • Participants' Personal Narratives on Their Experience with the Intervention Program [Time frame: Within six weeks after completing the treatment]

Eligibility criteria

Inclusion criteria

  • be at or older than 18 years old
  • understand Cantonese
  • read as well as write Chinese

Exclusion criteria

  • with borderline or greater intellectual deficits
  • weak language abilities
  • severe conditions related to mental, emotional, and/or behavioral functioning

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Hong Kong · 1 center
  • The Salvation Army SKY Family and Child Development Centre — Mong Kok

Identifiers

NCT: NCT07345806 · EA250563

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗