UMIN-CTR Clinical Trial

Public title

Adaptation of SOLACE program and its efficacy to reduce effects of
stigma on mental health of parents of children with autism spectrum
disorders: A Randomized Controlled Trial.

Acronym

Randomized Controlled Trial, Efficacy, Stigmatization protection program for parents, Autism Spectrum Disorder, mental health

Scientific Title

Adaptation of SOLACE program and its efficacy to reduce effects of
stigma on mental health of parents of children with autism spectrum
disorders

Scientific Title:Acronym

Randomized Controlled Trial, Efficacy, Stigmatization protection program for parents, Autism Spectrum Disorder, mental health

Region

Asia(except Japan)

Condition

Reduction in the level of self-stigma, social stigma, depression, anxiety,
stress and improvement in social support, self-esteem and self-compassion in parents of
children with ASD

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

1. To review indigenous literature on stigma, its misconception, myths, impact and coping
in cultural context in mothers of children with ASD to find out unique cultural aspects.
2. To adapt SOLACE from phase I.
3. To find out efficacy of adapted SOLACE program to combat stigma in parents of
children with ASD through RCT

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

To assess the efficacy of SOLACE program and to reduce effects of stigma on mental health of mothers of children with autism spectrum disorders(ASD). The measurement tools would be DASS(Lovibond & Lovibond, 1995), Perceived Autism Related Stigma by Association Scale (Rizwi & Batool, 2020),Perceived Courtesy Stigma Scale (PCSS) (Chan & Lam 2017),Self-esteem scale, Positive Meaning of Caregiving, Self-compassion Scale, Social support. This outcome will be measured within 4 months.

Key secondary outcomes

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Single blind -participants are blinded

Control

No treatment

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking

NO

Concealment

Central registration

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Other

Interventions/Control_1

Experimental group will receive SOLACE program to reduce the effects of stigma on mental health of mothers of children with autism spectrum disorders (ASD). This group will receive education about SOLACE program in about 10 sessions(only mothers will be given 8 sessions and Fathers will be given 2 sessions). Each session will be approximately 60-90 minutes.

Interventions/Control_2

Control group -1 will receive no treatment.

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1. Those who have received diagnosed of their child 1-2 year ago.
2. Whose children are mild to moderate on spectrum (pre-diagnosed).
3. Screened out mothers having moderate to high level of stigma on Perceived Autism
Related Stigma by Association Scale (Rizwi & Batool, 2020) will be selected.
4. Having access to the internet.
5. Having familiarity with mobile usage.
6. Having social media accounts like WhatsApp and Facebook will be recruited.
7. Having intact marriages.
8. Whose spouses are also available and give consent for sessions.
9. Mothers from Lahore.

Key exclusion criteria

1. Having an ASD child with comorbid conditions.
2. Having more than one diagnosed ASD child.
3. Who have been diagnosed with severe psychiatric illness themselves.
4. Divorced/single mother

Target sample size

100

Name of lead principal investigator

1st name	Fatima
Middle name	Salman
Last name	Qazi

Organization

Centre for Clinical Psychology, University of the Punjab, Lahore, Punjab, Pakistan

Division name

Lahore, Punjab, Pakistan

Zip code

54590

Address

F7H8+HFV, Canal Rd, Quaid-i-Azam Campus, Lahore, Punjab

TEL

03224081556

Email

fatima.qazi264@gmail.com

Name of contact person

1st name	Fatima
Middle name	Salman
Last name	Qazi

Organization

Centre for Clinical Psychology, University of the Punjab, Lahore, Punjab, Pakistan

Division name

Lahore, Punjab, Pakistan

Zip code

54590

Address

F7H8+HFV, Canal Rd, Quaid-i-Azam Campus, Lahore, Punjab

TEL

042-99230533

Homepage URL

https://pu.edu.pk/home/department/45

Email

info.ccpsy@pu.edu.pk

Institute

Centre for Clinical Psychology, University of the Punjab, Lahore, Punjab, Pakistan

Institute

Department

Personal name

Organization

Self-funded

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Centre for Clinical Psychology, University of the Punjab, Lahore, Punjab, Pakistan

Address

F8V2+V96, Quaid-i-Azam Campus, Lahore, Punjab

Tel

042-99230533

Email

info.ccpsy@pu.edu.pk

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2025

Year

05

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

50

Results

The culturally adapted SOLACE program significantly reduced stigma by association and parent self-stigma, while improving self-compassion, positive meaning in caregiving, social and spousal support, and self-esteem. Significant reductions were also observed in depression, anxiety, and stress scores compared to the control group.

Results date posted

2025

Year

09

Month

13

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

The baseline characteristics of the participants, enrolled in our study are given below: A total of 50 mothers of children with autism were recruited and randomly allocated to the experimental group (n = 25) and wait-list control group (n = 25). Of these, 47 participants (94%) completed the study, with three dropouts due to personal reasons. The mean age of mothers was 34.58 years (SD = 5.79), while the mean age of fathers was 40.82 years (SD = 4.81), with no significant between-group differences. The average age of children was 5.06 years (SD = 1.53), and the mean age at diagnosis was 3.16 years (SD = 0.95), with a significant difference observed between groups (p = 0.03).

Most participating children were male (74%), and the majority of mothers were housewives (98%). The family structure was predominantly joint (74%), with nuclear families constituting 26%. Autism severity, as measured by CARS, was distributed across mild (48%), moderate (48%), and severe (4%) categories, with no significant group differences. Importantly, none of the children presented with comorbid diagnoses, ensuring sample homogeneity.

Attendance at the parent support group was universal, with 100% participation across both experimental and control groups, highlighting strong engagement and feasibility.

Stratified randomization was conducted on site (venue of recruitment), child's severity level of autism and baseline stigma scores. Overall, baseline demographic and clinical characteristics were comparable between the intervention and wait-list control groups, indicating initial equivalence of the two arms prior to the intervention.

Participant flow

A total of 70 mothers of children with autism were initially screened for eligibility. Of these, 20 were excluded: 11 did not meet inclusion criteria, 8 declined participation, and 1 was excluded for other reasons (e.g., comorbid conditions or not meeting the required stigma score). The remaining 50 mothers met the eligibility criteria and were randomized into the intervention group (n = 25) or the wait-list control group (n = 25).

Among those randomized, 47 participants (94%) completed the study. Three participants dropped out due to personal reasons, including family bereavement or relocation. All participants who completed the intervention attended every session, resulting in a high level of adherence. Fathers of the participating mothers (n = 50) were also recruited for two structured sessions aimed at strengthening spousal support, and they were evenly distributed across both groups.

Thus, the final sample analyzed under the intent-to-treat (ITT) principle consisted of 50 mothers (25 intervention, 25 control), with complete outcome data available for 47 mothers at post-assessment and 47 mothers at two-month follow-up.

Adverse events

None

Outcome measures

A range of validated standardized measures (translated and adapted into Urdu where required) were used to evaluate both primary and secondary outcomes of the trial.

Depression, Anxiety and Stress Scale (DASS-21; Lovibond & Lovibond, 1995): A self-report questionnaire measuring severity of depression, anxiety, and stress symptoms. Higher scores reflect greater psychological distress.

Perceived Autism-Related Stigma by Association Scale (PARSA; Rizvi & Batool, 2020): Assesses stigma experienced by parents of autistic children within Pakistani cultural context, covering attitudes of community, behaviors of community, and emotional burden. Higher scores indicate stronger perceived stigma.

Parent Stigma Scale (PSS; Eaton et al., 2019): Measures internalized stigma among parents, including self-blame, self-shame, and negative parent self-beliefs.

Self-Esteem Scale (RSE; Rosenberg, 1965): Assesses global self-worth on a 4-point scale, with lower scores reflecting reduced self-esteem.

Positive Meaning to Caregiving Scale (PMC; Lodder et al., 2020): Evaluates the extent to which parents derive positive meaning and personal growth from caregiving responsibilities.

Self-Compassion Scale (SCS; Neff, 2003): Measures six domains of self-compassion including self-kindness, common humanity, mindfulness, and reduced self-criticism.

MOS Social Support Survey (Sherbourne & Stewart, 1991): Assesses availability and adequacy of emotional, informational, and tangible social support.

Childhood Autism Rating Scale (CARS; Schopler et al., 1988): Used to confirm autism diagnosis and assess severity of autism symptoms.

Together, these measures captured stigma (both public and internalized), self-compassion, caregiving meaning, social/spousal support, self-esteem, and parental psychological well-being.

Plan to share IPD

IPD sharing Plan description

Recruitment status

Open public recruiting

Date of protocol fixation

2024

Year

02

Month

15

Day

Date of IRB

2024

Year

12

Month

08

Day

Anticipated trial start date

2024

Year

11

Month

11

Day

Last follow-up date

2025

Year

03

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2024

Year

11

Month

11

Day

Last modified on

2025

Year

09

Month

13

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064116

Single case data URL

Value
https://center6.umin.ac.jp/ice/64116