Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The goal of this randomized controlled trial is to test the effectiveness of a resilience intervention and an adherence intervention in improving health-related quality of life (HRQoL) among perinatally infected HIV positive children and their HIV positive mothers in China.
The main questions it aims to answer are:
Participating mother-child dyads in the two intervention arms will receive two sessions of dyadic intervention. Researchers will compare the above-described outcomes between participants in the two intervention arms and the control arm (treatment as usual) to see the effectiveness of the interventions.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Resilience intervention | Experimental | Participants (mother-child dyads) will receive two biweekly sessions of dyadic resilience intervention. |
|
| Adherence intervention | Experimental | Participants (mother-child dyads) will receive two biweekly sessions of dyadic adherence intervention. |
|
| Control | No Intervention | Participants will receive usual medical treatment. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Resilience intervention | Behavioral | Contents of the first session include:
Contents of the second session include:
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of health-related quality of life (HRQoL) | HRQoL will be measured by the Chinese short version of the World Health Organization Quality of Life (Whoqol Group, 1998). Possible scores range from 0 (worst HRQoL) to 104 (Best HRQoL). | Baseline, 2 weeks (immediately after the last session of intervention), 1 month and 3 months |
| Change of depressive symptoms | Depressive symptoms will be measured by the Patient Health Questionnaire-9 (Kroenke, Spitzer, & Williams, 2001). Possible scores range from 0 to 27, with a higher score indicating more depressive symptoms. | Baseline, 2 weeks (immediately after the last session of intervention), 1 month and 3 months |
| Change of anxiety symptoms | Anxiety symptoms will be measured by the Generalized Anxiety Disorder 7-item version (Spitzer et al., 2006). Possible scores range from 0 to 21, with a higher score indicating more anxiety symptoms. | Baseline, 2 weeks (immediately after the last session of intervention), 1 month and 3 months |
| Change of resilience factors | Resilience factors will be measured by the 25-item Connor-Davidson Resilience Scale (Connor & Davidson, 2003). Possible scores range from 0 to 100, with a higher score indicating better resilience. | Baseline, 2 weeks (immediately after the last session of intervention), 1 month and 3 months |
| Change of HAART adherence | Adherence will be measured by (a) a visual analog scale asking the level of adherence (Zhang et al., 2020). Possible scores range from 0 (never adhere) to 10 (always adhere); and (b) single-item questions asking about missing and delayed doses in the last three days, seven days (one week) and 30 days (one month). Children will be asked to report their own adherence behaviors, and mothers will be asked to report both their own and their children's. |
| Measure | Description | Time Frame |
|---|---|---|
| Change of mother-child relationship and interaction: Dyadic coping | Dyadic coping will be assessed by two subscales from the Dyadic Coping Inventory (Bodenmann, 2008), namely the common dyadic coping and the evaluation of the dyadic coping subscale. Possible scores range from 7 to 35, with a higher score indicating a higher level of dyadic coping. | Baseline, 2 weeks (immediately after the last session of intervention), 1 month and 3 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Xiaonan N. Yu, Dr. | City University of Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangxi Center for Disease Prevention and Control | Nanning | Guangxi | 530027 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Adherence intervention | Behavioral | Contents of the first session include:
Contents of the second session include:
|
|
| Baseline, 2 weeks (immediately after the last session of intervention), 1 month and 3 months |
| Change of mediators in the resilience intervention: Perceived stigma | Perceived stigma will be assessed by the 8-item HIV Stigma Scale (Berger et al., 2001; Li et al., 2016). Possible scores range from 8 to 32, with a higher score indicating a higher level of perceived stigma. | Baseline, 2 weeks (immediately after the last session of intervention) |
| Change of mediators in the resilience intervention: Emotional regulation | Emotional regulation will be assessed by the Emotional Management Strategy Questionnaire (Fabrizio et al., 2015). Possible scores range from 10 (worst emotional regulation) to 60 (best emotional regulation). | Baseline, 2 weeks (immediately after the last session of intervention) |
| Change of mediators in the resilience intervention: Positive coping | Positive coping will be assessed by a combination of the positive reappraisal subscale from the Cognitive Emotion Regulation Questionnaire (Garnefski et al., 2002; Zhu et al., 2008) and the Emotional Processing Subscale from the Emotional Approach Coping Scales (Stanon et al., 2000; Tse et al., 2020). Possible scores range from 8 to 40, with a higher score indicating better positive coping. | Baseline, 2 weeks (immediately after the last session of intervention) |
| Change of mediators in the resilience intervention: Social support | Social support will be assessed by a combination of the Perceived Social Support Scale (Blumenthal et al., 1987; Huang, Jiang, & Ren, 1996), the possible scores of which range from 0 (lowest level of support) to 72 (highest level of support), and the usage of support subscale of the Social Support Assessment Scale (Xiao & Yang, 1987), the possible scores of which range from 3 (lowest level of support utilization) to 12 (highest level of support utilization) | Baseline, 2 weeks (immediately after the last session of intervention) |
| Change of mediators in the resilience intervention: Self-efficacy | Self-efficacy will be assessed by the General Self-Efficacy Scale (Schwarzer & Aristi, 1997). Possible scores range from 10 to 40, with a higher score indicating a higher level of efficacy. | Baseline, 2 weeks (immediately after the last session of intervention) |
| Change of mediators in the adherence intervention: Adherence information, motivation, and behavioral skills | Adherence information, motivation, and behavioral skills will be assessed by the LifeWindows Information-Motivation-Behavioral Skills Antiretroviral Therapy Adherence Questionnaire (LifeWindows Project Team, 2006; Peng et al., 2020). Possible scores of the information, motivation, and behavioral skills subscale range from 9 to 45, 8 to 40, and 13 to 65, respectively, with a higher score indicating a higher level of information, motivation, and behavioral skills. | Baseline, 2 weeks (immediately after the last session of intervention) |
| Change of mediators in the adherence intervention: Illness perception | Illness perception will be assessed by the Brief Illness Perception Questionnaire (Broadbent et al., 2006). Possible scores of each of the eight items range from 0 to 10, and each item will be used separately. | Baseline, 2 weeks (immediately after the last session of intervention) |
| Change of mediators in the adherence intervention: Adherence efficacy | Adherence efficacy will be assessed by the HIV Treatment Adherence Self-Efficacy Scale (Johnson et al., 2007; Sun et al., 2016). Possible scores range from 0 to 120, with a higher score indicating a higher level of perceived efficacy. | Baseline, 2 weeks (immediately after the last session of intervention) |
| Change of mediators in the adherence intervention: Children's medication-taking responsibility | Children's medication-taking responsibility perception and allocation (between mother and child) will be assessed by two visual analog scales respectively. Possible scores of each item range from 0 to 10, with a higher score indicating more self-responsibility than mother-responsibility. | Baseline, 2 weeks (immediately after the last session of intervention) |
| Change of mother-child relationship and interaction: Mother-child closeness | Mother-child closeness will be assessed by the Closeness subscale of the Network of Relationships-Relationship Quality Version (Buhrmester & Furman, 2008; Kong et al., 2012), the possible scores of which range from 15 (lowest level of closeness) to 90 (highest level of closeness) and the Inclusion of Other in the Self Scale (Aron, A., Aron, N., & Smollan, 1992), the possible scores of which range from 1 (lowest level of closeness) to 7 (highest level of closeness). | Baseline, 2 weeks (immediately after the last session of intervention), 1 month and 3 months |
| Change of mother-child relationship and interaction: Family harmony | Family harmony will be assessed by the Family Harmony Scale (Kavikondala et al., 2016). Possible scores range from 10 to 60, with a higher score indicating a higher level of harmony. | Baseline, 2 weeks (immediately after the last session of intervention), 1 month and 3 months |
| Change of mother-child relationship and interaction: Mother-child conflict | Mother-child conflict will be measured by the frequency and intensity of parent-child conflicts (Yau & Smetana, 1996), the possible scores of which range from 2 (no conflict) to 10 (highest level of conflict). | Baseline, 2 weeks (immediately after the last session of intervention), 1 month and 3 months |
| Change of mother-child relationship and interaction: Relationship satisfaction | Relationship satisfaction will be assessed by a single-item relationship ladder. Possible scores range from 0 to 10, with a higher score indicating a higher level of satisfaction. | Baseline, 2 weeks (immediately after the last session of intervention), 1 month and 3 months |