Efficacy of a psychoeducational intervention in caregivers of people with intellectual disabilities: A randomized controlled trial (EDUCA-IV trial)

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Abstract

Background

People with intellectual disabilities (ID) are usually cared for by their own parents, families or informal caregivers. Caring for a person with ID can have a negative impact on caregivers' mental health (burden, depression, anxiety). The main aim of the EDUCA-IV trial was testing the efficacy of a psychoeducational intervention program (PIP) versus standard practice and to see whether the PIP intervention would reduce the caregiver's burden at post-intervention (4 months) and at follow-up (8 months).

Method

This was a multi-centre randomised controlled trial including 194 caregivers (96 randomised to PIP, 98 to control condition). PIP intervention consists of 12 weekly group sessions. The control group received treatment as usual. Primary outcomes measured included the Zarit Burden Interview (ZBI). Secondary outcomes were caregivers' mental health (GHQ-28), anxiety (STAI) and depression (CES-D).

Results

The decrease of ZBI scores was not significant at 4 months. There was significant decrease in the GHQ scores at 4 and 8 months. CES-D showed relevant results at follow-up. Intention to treat analyses showed similar results.

Conclusions

The PIP intervention seems not to be effective reducing burden, but appears to have a positive result on general mental health. The program was well received and valued by caregivers.

Section snippets

What this paper adds?

Relatives are the ones who usually care for people with intellectual disability (ID), and, as informal caregivers, they may experience negative psychological consequences (i.e. caregiver burden, mental health issues, depression or anxiety). Despite this issue being well-known and described, there is a lack of well-designed studies assessing psychological interventions that could help caregivers cope with demanding/stressful situations. In this randomised controlled study we tested the efficacy

Hypothesis and design

The principal hypothesis of the EDUCA-IV trial is that informal caregivers allocated to the PIP condition would show less burden at post-intervention endpoint (4 months), and at follow-up (8 months) than caregivers allocated to control condition (wait list). The secondary hypothesis was that caregivers allocated to PIP condition would also show a significant improvement in mental health conditions (well-being, depression, and anxiety) after intervention and at follow-up compared to caregivers

Recruitment, losses to follow-up and fidelity

A total of 323 dyads were assessed for eligibility. 73 did not meet selection criteria, and 56 refused to participate. The remaining 194 caregivers were recruited to participate and randomised (96 to PIP and 98 to control condition), from October 2015 to January 2016. The last visit took place throughout the period June – September 2016. Fig. 1 shows the trial flowchart. Data from 7 research sites were included in the analysis. The median recruitment by research site was 27.7 caregivers (range

Discussion

Parents providing ongoing care to people with intellectual disabilities are found to be at risk of adverse mental health outcomes such as burden, distress, depression or anxiety. The current study endorses this problem (baseline scores) and has tested the efficacy of a psychoeducational intervention in a sample of informal caregivers of people with intellectual disabilities. According to our results, we cannot confirm the primary hypothesis related to the efficacy of our intervention.

Measures

Conclusions

Our study shows that informal caregivers of people with intellectual disabilities may present negative consequences that affect their mental health (burden, distress, risk of depression and anxiety) and should receive assistance, especially those with a higher burden. We developed a psychoeducational intervention (12 group weekly sessions) to improve their psychological wellbeing. Using an experimental methodology, we found positive results on general mental health but not on caregiver burden,

Declaration of Competing Interest

None.

Acknowledgements

The EDUCA-IV trial was funded by Sisters Hospitallers. The role of the funding source was limited to economic support. It was not involved in the study process, preparation or submission of the manuscript.

The EDUCA-IV researchers involved are Salud Jiménez Ballesteros, Yolanda Martínez Campos, Mª Ángeles Burgos Pulido, Elena Navarro Mateos, María del Carmen Mesa Martínez, Ana Isabel Pérez González, María de los Ángeles Iañez Velazco, Iván Martínez Rodríguez, Cristina García Hernández, Jesica

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