PACT Programme for Parents of Children With SHCN

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorChinese University of Hong Kong

About this trial

This randomised controlled trial aims to determine the efficacy of a 12-week, smartphone-based Prosocial-orientated Acceptance and Commitment Training (PACT) programme plus age-appropriate positive parenting advice on the psychological flexibility, prosociality, parenting competence and family functioning with parents of children with special health care needs as well as the mental well-being of parent-child dyads over 12 months follow-up.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Cantonese-speaking Hong Kong residents

Living together with the child who is at preschool/school-age (3-8 years old)

Caregivers who adopted the responsibility of taking care of the child,

has daily access to their iPhone and Android smartphones.

Disqualifiers

Parents who have diagnoses of severe mental illness or developmental disabilities, such as intellectual disabilities

Trial design

Design model

Parallel

Treatments tested in this trial

  • Prosocial-orientated Acceptance and Commitment Training plus positive parenting advice

    Behavioral

    The PACT group will receive a combination of 6 online modules and 4 group-based video conferencing sessions of Prosocial-orientated Acceptance and Commitment Training plus positive parenting advice via a mobile app across 12 weeks. The modules will cover real-life scenarios of daily parenting challenges in caring for a child with SHCN, followed by age-appropriate positive parenting advice based on the Centers for Disease Control and Prevention guidelines. After going through the scenarios, parents will be audio/visually guided to participate in ACT activities, including mindfulness exercises, ACT metaphors and experiential exercises, which will be used to increase psychological flexibility.

  • Positive parenting advice

    Behavioral

    The Control Group will receive a total of 6 online modules and 4 group-based video conferencing sessions in a closed group of 6-8, 60 minutes per session guided by a trained facilitator via the mobile app across 12 weeks. The online modules will provide identical contents to those in the PACT group, but no guided ACT metaphors or experiential exercises. The interaction sessions serve to review and discuss the contents of online modules, but without the contents related to ACT/prosociality.

Treatment groups

196 Participants
are divided into 2 treatment groups
Group A: PACT GroupExperimental treatment 1 intervention
Group B: Control GroupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Parental mental well-being

The 14-item Mental Health Continuum Short Form for Adults (MHC-SF) will be used to assess the emotional, social and psychological well-being of parents. MHC-SF can be scored between 0 and 5 (6 points Likert scale), which means that the total score on the scale can range from 0 to 70 points. Higher scores indicate a higher level of emotional wellbeing. scaleThe MHC-SF subscales possessed good convergent validity and internal consistencies in Western populations (Lamers et al., 2011).

Time frame
Change from baseline assessment to immediate, 3, 6 and 12 months post-intervention
2

Child mental well-being

The 25-item Strengths and Difficulties Questionnaire (SDQ, 25 items, 3-point Likert scale) will be adopted to evaluate the psychological adjustment of children with SHCN, in terms of conduct problems, hyperactivity, emotional symptoms, peer problems and prosocial behaviours. A total difficulties score can be generated by summing scores from all the scales except the prosocial scale. The resultant score ranges from 0 to 40. The SDQ is one of the most commonly used proxy reports from parents to assess the psychopathology of their children aged 3-16 years (Lai et al., 2010).

Time frame
Change from baseline assessment to immediate, 3, 6 and 12 months post-intervention

Secondary outcomes

1

Parental psychological flexibility

The 6-item PsyFlex (5-point Likert Scale) will assess all six therapeutic processes in Acceptance and Commitment Therapy (ACT). Each item refers to one of the core skills that ACT focuses on when developing psychological flexibility and well-being. The score is then interpreted such that higher scores represent higher psychological flexibility. (Hayes et al., 2011).

Time frame
Change from baseline assessment to immediate, 3, 6 and 12 months post-intervention
2

Parental prosociality

The 16-item Prosocialness Scale for Adults assesses 4 types of prosocial behaviours, including sharing, helping, taking care of, and feeling empathic with others from 1 (never/almost never) to 5 (almost always/always true) and summing all responses and finding the mean to get a total score (Caprara et al., 2005).

Time frame
Change from baseline assessment to immediate, 3, 6 and 12 months post-intervention
3

Parenting competence

The 17-item Chinese Version of the Parenting Sense of Competency Scale (C-PSOC; Ngai, Chan,\& Holroyd E, 2007) will be used to assess parents' perceptions of their abilities to manage parenting needs. The PSOC comprises two subscales - the Efficacy subscale and the Satisfaction subscale. The Efficacy subscale contains eight items measuring parents' perception of competence in the parenting role. Differently, the Satisfaction subscale contains nine items evaluating the satisfaction and comfort of parents with the parenting role. Each item is scored using a 6-point Likert scale, ranging from 1 (strongly disagree) to 6 (strongly agree). The total score ranges from 17 to 102, while subscale scores range for the Efficacy and Satisfaction subscales are 17 to 48 and 17 to 54, respectively. The higher the score, the higher sense of competence and satisfaction in parenting. The PSOC had adequate internal consistencies (α=.77-.85) and test-retest reliabilities (r=.87) among Hong Kong parents.

Time frame
Change from baseline assessment to immediate, 3, 6 and 12 months post-intervention
4

Family functioning

The 36-item Chinese version of the Pediatric Quality of Life Inventory Family Impact Module (PedsQL FIM; Chen et al., 2011) will be adopted to assess the impact of pediatric asthma comorbid with ADHD on parent health-related quality of life and the family functioning. The PedsQL FIM consists of 8 subscales: Physical Functioning (6 items), Emotional Functioning (5 items), Social Functioning (4 items), Cognitive Functioning (5 items), Communication (3 items), Worry (5 items), Daily Activities (3 items) and Family Relationships (5 items). The former six subscales measure parents' overall functioning, while the latter two subscales measure parent-reported family functioning. Each item has five Likert response options, which are 0 (never a problem) to 4 (almost always a problem). Items are then linearly transformed to a 0-100 scale (0 = 100, 1 = 75, 2 = 50, 3 = 25, 4 = 0) and averaged by the number of items, so that higher scores indicate better health-related quality of life.

Time frame
Change from baseline assessment to immediate, 3, 6 and 12 months post-intervention

Other outcomes

Sponsors and contacts

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Chinese University of Hong Kong

Lead sponsor

Hong Kong Children's Hospital

Collaborator

Hong Kong Young Women's Christian Association

Collaborator